Certificate Programmes

Institute of Good Manufacturing Practices India R
IGMPI
Global accredited training & certification provider
Conferred with QUALITY COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD &
ASSOCHAM Services Excellence Award 2017
Trusted by organizations & training participants in over 30 countries

Training | Certification | Education | Research
PROSPECTUS
CERTIFICATE PROGRAMMES IN
 GMP for Finished Pharmaceuticals & Good  Drug Registration (US Market-ANDA, NDA etc)
Manufacturing Practice in Manufacturing,  Preparation and Submission of Drug Master File (DMF)
Processing, Packing, or Holding of Drugs.  Prescription to OTC Switch
 GMP In Manufacturing, Packing, or Holding  Computer System Validation
Human Food  Pharmaceutical Validation
 Food and Drug Regulatory Agencies  Computer Aided Drug Design (CADD)
 Process Analytical Technology  Good Clinical Practices (GCP)
 Documentation in QA & QC Department  Analytical Testing and Equipment
 Registration of Drug and Dossier Preparation (CTD  Sterile Manufacturing
and eCTD submissions)  Naturopathic Science
 Drug Registration (European market)  Quality by Design
 Drug Registration (GCC countries)  Chemical Safety
 Drug Registration (African countries)  HVAC Systems Validation
 Drug Registration (India)  Certificate in Quality Management System for Medical
 WHO-GMP Devices (ISO 13485)
 European Union (EU) Medical Devices Regulation  Medical Devices Directive, CE Marking for Europe
 In Vitro Diagnostic Medical Device Directive – CE (93/42/EEC)
Marking for Europe (98/79/EC)  Technical Documentation (93/42/EEC)
 EU IVD Medical Device Regulation
(3 Months Advanced Programme)

IGMPI
About IGMPI
Institute of Good Manufacturing Practices India, registered as a non-profit society ( under The
Societies Registration Act,1860) with Government of India recognised by the Department of Industrial
Policy & Promotion, Ministry of Commerce & Industry, Government of India, accredited Vocational
Institution of Ministry of HRD, Government of India, approved training Institute of Food Safety and
Standards Authority of India (FSSAI) and affiliated with Life Sciences Sector Skills Council (SSC) and
Food Industry Sector Skills Council of National Skill Development Corporation (NSDC) -presents
unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an
essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic,
medical device and food manufacturing. GMP in itself is the most dynamic part which witnesses
frequent changes in terms of newer rules being added and older ones being renewed. Keeping self
updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs
and practices.
Our group of learned professionals from above mentioned sectors of the Pharma, Healthcare and
Food industries have put together their knowledge; know about and practical experiences in form of
this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition
as stronger and better training platform provider for professionals and students in the aeas of GMP,
Quality Assurance and Control, Pharma, Food and healthcare Regulatory Affairs, Clinical Research,
Pharmaceutical IPR and Good Laboratory Practice and Product Management. The importance of
quality healthcare and foods is known to our founders and thus numerous efforts are being made to
offer friendly but effective and easy regular, part-time and online/distance sources of GMP training,
Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research,
Pharmaceutical IPR and Good Laboratory Practice in form of formal classroom studies,
distance/online/interactive courses, online seminars, as well as onsite training programmes along
with knowledge of worldwide affairs of the industry; in short a round-the-clock help for any
information in these areas needed by anybody from around the world. Based on high standard of
quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality
Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management,
Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design
and Discovery, Food QA&QC etc areas have been approved by Quality Council of India, which is an
autonomous body and an accreditation authority for education & vocational training providers under
the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of
India.
The IGMPI's team of technology experts and other Industry advisors together pursue to make cGMP
knowledge, training in the area of Pharma and Food manufacturing easily accessible, through this
platform.
IGMPI
Accreditation and Awards

Institute of Good Manufacturing Practices India (IGMPI) is registered as a non-profit society with its
own Memorandum of Association and bye-laws under The Societies Registration Act, 1860,
Government of India.
IGMPI is recognized by Department of Industrial Policy & Promotion, Ministry of Commerce &
Industry, Government of India and is an accredited Vocational Institution of Ministry of HRD,
Government of India (AVI no-710367) and all the courses of IGMPI are approved for life time
empanelment under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh also.
The quality based Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing
Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control,
Public Health, Nanotechnology, Product Management, Sales and Marketing Management, Clinical
Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding
have been duly assessed and approved by Quality Council of India, Government of India based on
fulfillment of following criteria:
1. Course Content
2. Course Design
3. Course Material
4. Instructors
5. Class size & Attendance
6. Facilities
7. Evaluation of Students
8. Written Examination
9. Certificate
IGMPI is also an ISO 9001:2015 Certified Organisation accredited under Dubai Accreditation Center
(DAC), Accreditation Department, Government of Dubai, UAE and has been conferred with QUALITY
COUNCIL OF INDIA (QCI) – D.L. SHAH NATIONAL QUALITY AWARD – Certificate of Merit 2015 &
ASSOCHAM Services Excellence Award 2017.
IGMPI is affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council
set up by National Skill Development Corporation (NSDC) as well.
IGMPI is an approved Training Institute of Food Safety and Standards Authority of India (FSSAI)
(FSSAI ID: TPINS18) IGMPI PHARMA® is licensed by Department of Food Safety & Drug Administration
under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006.
IGMPI is a PMKVY (Pradhan Mantri Kaushal Vikas Yojna) affiliated training partner ( SMART TP
Number: Tp010908)
IGMPI also offers International Register of Certificated Auditors (IRCA) Accredited Lead Auditor
course periodically.
IGMPI is also registered under Section 23 (2), Rule 56 (1), Trade Marks Act, 1999, Government of India
(Reference No. 2738626).
IGMPI
Quality Council of India (QCI)

Quality Council of India is set up by the Government of India to establish and operate national
accreditation structure and promote quality through National Quality Campaign. QCI is registered as a
non-profit society with its own Memorandum of Association. QCI is governed by a Council of 38
members and Chairman of QCI is appointed by the Prime Minister on recommendation of the industry
to the government. The Department of Industrial Policy & Promotion, Ministry of Commerce &
Industry, is the nodal ministry for QCI.
National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of
International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory
to its MLAs for Quality Management Systems, Environmental Management Systems and Product
Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation
(ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for
Inspection.
National Skill Development Corporation (NSDC)

The National Skill Development Corporation (NSDC), working under the aegis of the Ministry of Skill
Development and Entrepreneurship, is an apex organization for skill development in the country. The
NSDC is responsible for overseeing the many Sector Skill Councils as well as other skill development and
promotional activities across the country. It also implements many Government of India skill schemes such
as Pradhan Mantri Kaushal Vikas Yojana (PMKVY) and UDAAN.
NSDC was set up by the Government of India as part of the national skill development mission in order to
fulfill the growing need for skilled manpower across sectors. The Chairman of NSDC is nominated by
Government of India.
IGMPI
ADVISORY BOARD AND TEAM

Dr. Mahesh C Gupta, Chief Advisor: Dr. Mahesh
C Gupta is an experienced and internationally
reputed Scientist in the field of calibration,
quality assurance and testing. He has worked
with many government organizations like
National Physical Laboratory (NPLI), New Delhi
for 32 years and later with Dubai Central
Laboratory, Dubai as Principal Quality Officer.
He has also played a vital role in developing lab
accreditation program of India as Head National
Calibration Program. He is also the founder
president of Indian quality association. He has expertise and proficiency in various fields like
calibration, GLP, analytical techniques, quality assurance, laboratory inter-comparison, proficiency
testing, QMS and many more. With his knowledge and rich experience, he is focused on practical
aspects of current needs, contemporary and emerging trends, besides alerting the laboratories for
future challenges. A PhD from Indian Institute of Technology (IIT), New Delhi, Dr. Mahesh C Gupta has
been associated as a research fellow of Optical Society of India, Fellow of Indian Society of Lighting
Engineers and Vacuum society of India. He is also currently managing Lab World Magazine –a
renowned world class magazine dedicated to Quality Testing and Calibration laboratories in all
sectors- as the Editor in Chief.
Mr. Vinod Kumar Arora, Principal Advisor: Mr. Vinod Kumar Arora is an internationally acclaimed
industry professional having 35 years of rich experience in pharmaceutical development in the areas
of Generics, Differentiated, NDDS/NCE Dosage Forms. He is now associated with IGMPI as an advisor.
He joined Ranbaxy in 1983 where he initially worked as scientist for almost 4 years. He rejoined
Ranbaxy in 1994 where graduated to Vice President level from Assistant Director position. During his
association with Ranbaxy he developed products - Generics, Differentiated Generics, NDA's and NCE-
Global, market specific and OTC. Prior to his association with Ranbaxy, he worked as an Assistant
General Manager with the Formulation Development Research in Cadila Laboratories, Ahmedabad
and helped in setting up of Onco-manufacturing facility and developed several oncology products. He
has expertise in Dosage Form development in the area of dosage forms – Solids -Tablets / Capsules /
Granules / Pellets /PFOS/TFOS; Non-solids –Liquid /Injectables including Lyophilised/Topicals,
Inhalations – DPI/ pMDI and Nasal Spray, Dosage Forms Technology such as Nanotechnology, Depot
Injection; Modified Release tablets/suspension, Self-Emulsifying System, Oro dispersing tablets/oro -
dissolving strips; Particles/Pellets coating and has good understanding of current Good Manufacturing
Practices and QA/QC. He has made presentations to NDAC Committee for New Drugs Approval in
India, had meetings with Oman MOH and Pre IND meetings with USFDA. He has also
authored/coauthored over 100 patents in the area of NCE/ Differentiated products /NDDS/Generics.
With his knowledge and rich experience, he is focused on practical aspects of current needs,
contemporary and emerging trends, besides alerting the pharmaceutical industries for future
challenges. He is holding many honorary positions -Member of Indian Pharmacopoeia Scientific Body ,
Panel member of INMAS-DRDO, Ranbaxy Science Foundation Scholars Award , Global Expert
committee member of DFE Pharma , Germany and Distinguished Scientist from World Whos Who
IGMPI
Society , Member of Indian Pharma Committee of Make in India Campaign etc. He was felicitated by
Hon'ble former President of India, Dr A P J Abdul Kalam for development and launch of first NCE – Anti
malarial from India. Mr. Vinod Arora is a M. Pharm degree holder from BHU and DBM from IMM, New
Delhi. As one of our principal advisors he will be supporting our initiatives nationally and
internationally to rest of faculty members of IGMPI in imparting education, training and continuing
education programs as well as our knowledge dissemination initiatives like Current GMP,QA/QC,
Regulatory affairs ,Clinical research guidelines and news updates.
Mr. Syed Q. Abbas, Advisor: An eminent and a dynamic person, with a rich experience of 37 years in the
food Industry. Prior to associating with IGMPI, Mr Abbas has been working in the Food Corporation of
India under both state and central governments in the various departments. He has specialized
experience in Storage and Preservation of food grains, Quality Assurance and Quality Control & Supply
Chain Management. He has a rich exposure in food safety and quality. He has successfully carried out
audits, faced CAG and statutory audits for food safety and quality in the FCI. He has provided trainings
and has organized a series of workshops for food professionals. He is presently active in providing our
Faculty of Food Safety & Quality his valuable leadership to take it to the new level in the future.
Ms. Rajni Jha, Advisor: Ms. Rajni Jha, an expert professional in International Regulatory Affairs and
Quality Assurance for APIs for US, European as well as Asia-Pacific markets completed her M.Sc. and
Post M.Sc Research work from I.I.T., Kanpur. She has more than 20 years of rich experience working
with various pharmaceutical companies like Ranbaxy, Morepen Laboratories, Torrent Pharma,
Nicholas Piramal, Unimark Labs, Glenmark Generics and Indswift Labs Ltd.
She is associated with IGMPI for development of training modules , e-lectures, personal lectures,
workshops etc. Owing to her skills and proficiency; she had been leading a team of both RA and QA
personnel from different departments. Her key responsibilities and roles included submission of API
Dossiers including Drug Master Files (DMFs), Technical Data Packages (TDPs) and their updates,
Supplements, Amendments, Responses to Queries of different Intermediates & APIs for Filing
purposes to Regulatory authorities of various countries as per current global Regulatory guidelines for
approvals across all markets (USA, Europe, Australia, Latin America, Asia Pacific, Russia, etc.),
development and upgradation of various Protocols /Checklists for CQA as well as RA, assessment of
various outsourced DMFs and maintenance of existing DMFs, preparation and streamlining of SOPs,
etc. She has also successfully completed USFDA, PMDA, TGA, MHRA and Greece Authority audits for
GMP compliance for outsourced intermediates and APIs as a part of QA function. She has attended
various conferences/seminars on Regulatory Affairs, Quality Assurance and compliance through both
domestic and International training programs. She has also been actively involved in imparting
internal training and creating awareness on current GMP requirements, data generation with respect
to regulatory requirements and updating of systems with current regulatory requirements across
different departments in various organizations through training modules and workshops.
Dr. Manjusha Rajarshi, Advisor: Dr. Manjusha Rajarshi has more than 20 years of rich experience in
the pharmaceutical industry (various companies -Bayer, Aventis Pasteur, Unichem, B. Braun); Her
various career moves from training department, medical department, clinical operations and
regulatory affairs and medical affairs. Her industry exposures include: Clinical trial sites and sponsor
sites audited for GCP compliance; PV skills assessed via PV inspections of EMA from global
headquarters; for 4 years, Local Person Responsible for PV, with Servier, India. She is honourable
member of i) the Medical Committee with OPPI (organization of Pharmaceutical Producers of India),
member of the committee for deliberations of GCP guidelines, PV guidelines to the Indian
IGMPI
Regulatory Authorities ii) Pharmacy Council of India (PCI), iii) Indian Society of Clinical Research (ISCR),
iv) Indian Association for Statistics in Clinical Trial. Besides, therapeutic areas handled by her are
cardiology, diabetology, venous diseases, neuro-psychiatry, vaccines and many other internal
medicinal therapies. She has more than 25 publications published on behalf of international journals
such as IJCP, American Journal of Cardiovascular Drugs, Neurology, International Journal of Cardiology,
Diabetes Research etc
Ms. Amrita Bhattacharya, Associate Professor: Amrita is associated with IGMPI as an Associate
Professor. She is engaged in developing modules, e-lectures at her best in the disciplines of Good
Manufacturing Practices, Clinical Research, Quality Assurance, Quality Control, Pharmacovigilance,
Public Health & Hospital Administration. She has worked with many pharmaceutical & healthcare
companies like many pharmaceutical companies like Fortis Clinical Research and Jubilant Clinsys
having more than 6 years of experience. She has successfully conducted clinical studies for US FDA,
EMEA, DCGI & for several reputed Pharma companies. She is also having technical expertise in
conducting Clinical Trials Phase I & Phase II. Amrita has also performed pre-qualification and post-
qualification audits for Quality Assurance & Quality Control & Good Manufacturing Practices. Amrita
has completed her graduation in Microbiology from Lady Amritbai Daga &Smt. Ratnidevi Purohit
College for Women, Nagpur and Master's Degree in Biotechnology from Rani Durgavati University,
Jabalpur.
Ms. Sneha Gupta, Senior Faculty Member: She is a highly experienced Regulatory Affairs professional
with exceptionally positive personality. She has specialized experience in managing all kinds of
Regulatory and Start-up activities for Clinical Research (across multiple therapeutic areas), Product
Registrations, Quality Management, Training Workshops and Conferences for India and South-east
Asia. She possess working knowledge of key International Regulations (that of USFDA, EMEA, Health
Canada and WHO) for the Pharmaceutical and Clinical Research Industry. Ms. Sneha is a “Certified
Trainer” for clinical trials regulatory affairs and corporate behavior. Her academic profile encompasses
B. Tech in Biotechnology and Masters in Clinical Research along with a Certificate Course in Intellectual
Property Rights (IPR). Also, she has undergone professional trainings/certifications in Schedule-Y and
Indian GCP; Good Laboratory Practices (GLP); IPR and TRIPS Agreement; Preparation, Filing and
Review of Regulatory documents; Guidelines for Cosmetic Registration and Import and many others.
Apart from Regulatory and Study Start-Up Operations Management, her areas of expertise include
Quality Control and Internal Quality Audits of Regulatory Documents; Strategic Risk Management and
Mitigation Strategies; Client Management & Retention Negotiations; Business development; Training
and Development; and Strong Analytical and Content Development Skills. She has attained wealthy
proficient experience as a Regulatory affairs professional by serving for 8 years in different
organizations like Jubilant Clinsys Pvt. Ltd., Asiatic Clinical Research, Lambda Therapeutic Research;
Indian Council of Medical Research; and GVK Bio among others which has eventually helped her
develop excellent working relationships at Regulatory Agencies and Scientific Committees. Sneha
authored an article titled “Implications of Drugs Going Off Patent” published in magazine “Lifescience
India” and has co-authored a chapter on “Anti-Retroviral Medication” for a book on Clinical
Pharmacology by Dr. S. D. Seth. She also writes a blog named CheersZindagi.
Ms. Priyanka Kapoor, Senior Faculty Member: A passionate professional working as a Quality
assurance and training expert in the field of Clinical Research for the last 7.5 years. Her professional
skills include designing and implementing Quality systems within organizations; Performing audits for
all Clinical Study phases and BA/BE studies; Preparation and review of SOP's, Protocols; Managing
IGMPI
regulatory and sponsor inspection and performing Vendor Qualification Audits. She has gained rich
industry exposure from Fortis Clinical Research Ltd, Ranbaxy Research Laboratories and others. Ms.
Priyanka has done research work on 'Method development and validation for analysis of molecules on
LC-MS/MS extraction procedure' and 'Biological sample analysis for submission of ANDA'. She has also
worked as a part of Regulatory Inspection Management Team and faced inspection from FDA, ANVISA,
MHRA, WHO etc. Her academic credentials include B. Pharm and M. Pharm (Pharmaceutical
Chemistry) with a Post Graduate Diploma in Clinical Research and Pharmacovigilance and Clinical Data
Management. She has two research papers published to her name on “Effect of extract of Zizyphus
mauritiana Linn, Root on bacteria causing diarrhoea” in Insian Pharmacist Nov, 2004 and
“Pharmacognostical features of Zizyphus mauritiana Linn” in Ancient science of life, Sept 2004.
Dr. Sunita Sharma, Associate Professor: A life science professional, Dr. Sunita Sharma has more than
twelve years of research exposure on Industrial pharmaceuticals. Being proficient in diverse areas of
strain improvement, process development and fermentation based pharmaceuticals; she has deep
interest & vast exposure in GLP/GMP & patent infringement. She also has adequate knowledge of
International regulatory guidelines. She has also been associated with Ranbaxy Laboratories Limited
as a group leader in the department of fermentation and International Drug Regulatory Affairs. There
she has been entrusted with submitting Drug Master Files/Registration Dossiers for in-house
manufactured APIs to various regulatory authorities. As per her academic experience, she has worked
as a lecturer over three years in the department of microbiology, School of life Sciences, Guru Nanak
Dev University, Amritsar. Apart from these, she is also an Ex- Member of Board of studies and Board of
control of Microbiology department, Guru Nanak Dev University, Amritsar, India. She has completed
her B.Sc, M.Sc and Ph.D. from School of Life Sciences, Guru Nanak Dev University, Amritsar, India.
Dr. Shikha Kumar, Advisor: Dr Shikha Kumar is one of our faculty members and trainers. She has deep
interest and vast exposure in GMP training, writing pharma & healthcare related modules and
regulatory documents. She has completed her bachelor's in pharmacy from K.N.M.I.P.E.R, Modinagar
and her master's in pharmacy from I.T B.H.U, Varanasi. She has also completed her Ph.D from Hamdard
University, New Delhi. Apart from these, she is also trained in regulatory affairs and in medical and
clinical research writing. She has worked for a couple of pharmaceutical companies i.e. Eli Lilly and
Torrent Pharmaceuticals Limited. There she has been entrusted for manuscript writing for non-clinical
and clinical studies, compilation of CMC and IMPD for IND filling in UK and India. She has about 15
research articles as an author and about 10 publications as a medical writer in peer-reviewed journals.
She has also done patent writing and medical letters writing. During her job in pharma companies, she
has also written protocols, investigator's brochure, scientific reports and newsletters for clinical trials.
She is fond of writing health related articles and regulatory documents.
Ms. Pooja K. Arora, Advisor: Pooja K Arora, a Healthcare industry professional has acquired her
Master's degree in Clinical Research from Cranfield University, UK and professional Diplomas in
Pharmaceutical Industry Regulatory Affairs and Pharmaceutical Management from reputed institutes.
She has been associated with Clinical Research associate with a few CROs and thus had hands on
working basis of the industry. She is presently associated with IGMPI as one of its advisors.
Dr. Snehal Singh, Advisor: Dr. Snehal Singh has a diverse experience of more than 8 years in medical/
scientific/ E-learning and educational writing, which includes good manufacturing practices, clinical
research and scientific documents, medico-marketing material, training manuals, E-learning coursem
modules, patient education material and educational counseling. She has worked with esteemed
organizations like Institute of Preventive Cardiology, Oxygen Healthcare Communications, Satyam
IGMPI
BPO and Novartis Healthcare Pvt Ltd. She is a qualified medical professional (B.H.M.S) and has earned
Post Graduation in Hospital & Healthcare Management (PGDHHM) and in Preventive & Promotive
Health Care (PGDPPHC) on her name. She has also worked as an editor to several health magazines
like Health and Wellness, Alternative Medicine, Nutrition and fitness, Pregnancy, Parenting and Child
health. She is also experienced in imparting corporate training and training material development.
Ms. Shikha Thakur, Assistant Professor: Shikha Thakur is working with IGMPI as an Assistant Professor.
She is responsible for developing training modules e-lectures, personal lectures delivering her best of
knowledge and skills in the domain of Quality Control, Quality Assurance & Good Laboratory Practice.
She is currently also indulged in providing assistance to our senior faculty members in the finalization
of training modules' syllabi, content and methodology and conducting e and personal lectures. She is
an alumnus of ISF College of Pharmacy, Punjab Technical University, Jalandhar, where she did her
Bachelor's and Master's programme in pharmacy with specialization in Quality Assurance. As her
remarkable achievement, she is a recipient of DST sponsored PTU fellowship for project entitled
“Solubility enhancement of Arteether: Formulation Development and Optimization. She has been
entrusted with responsibility of helping advisors and Director General of the Institute in providing the
distance cum e-learning and regular participants and trainees with experiential training in the areas of
Quality Assurance and Quality Control, Regulatory Affairs, Clinical Research and Good Laboratory
Practice.
Ms. Harshita Sharma, Assistant Professor: Currently as an Assistant Professor, Harshita is working on
training modules development and co-ordination with an objective of achieving larger mission and
goals of the organization. With deep interest and academic excellence in the areas of Pharmaceutics,
Quality Assurance & Quality Control, Regulatory Affairs Good Manufacturing Practices and Intellectual
Property Rights, she keeps a close watch on latest developments in the Industry. In addition to these
responsibilities, she is playing a key role in setting up Project Training division of IGMPI. Harshita has
completed B. Pharmacy from Maharaja Surajmal Institute of Pharmacy, IP University, Delhi, and
M.Pharmacy with specialization in Pharmaceutics from ISF College of Pharmacy, Punjab Technical
University, Jalandhar and is a Ph.D. scholar in the Faculty of Pharmacy, Jamia Hamdard University, New
Delhi. Aside from her regular association with IGMPI, she is presently designated as an independent
Non-Executive Director in Medicamen Biotech Limited as well.
Ms. Dilrose Pabla, Assistant Professor: Dilrose Pabla has taken up the responsibilities of assisting senior
faculty members and advisors of the Institute in development of training modules, e-lectures, training
kits, regulatory guidelines etc. Quality Assurance & Quality Control, Regulatory Affairs, Intellectual
Property Rights, Nanotechnology & Good Manufacturing Practices are her areas of interest and
exploration. She is also playing a key role in organising guest lectures by eminent Industry
professionals. Dilrose has completed B. Pharmacy from Sigma Institute of Pharmacy, Gujarat
University, Ahmedabad, and M.Pharmacy with specialization in Pharmaceutics from ISF College of
Pharmacy, Punjab Technical University, Jalandharand is a Ph.D. scholar in Punjab Technical University.
Ms. Ankita Gururani, Assistant Professor: An industry professional with management experience,
Ankita Gururani has been associated with implementation of quality assurance in FMCG sector. She
has completed her Bachelors in Medical Microbiology from H.N.B Central University and Masters in
Microbiology from Amity University, Noida. Apart from these, she has also acquired acertification on
Patent Analyst and has thorough knowledge on IPR, database searches. SWOT, CI, patent portfolio
and landscaping. She has also worked with Britannia India Ltd., where she was been entrusted with the
IGMPI
responsibility of conducting internal audit programs and implemented QNN and 5S as part of
manufacturing excellence. At IGMPI, Ankita has an important role to play in the development of the
course content and training modules in the field of food safety and quality assurance with an objective
of achieving larger mission and goals of the organization.
Ms. Neharika Thakur, Assistant Professor: A logical thinker with immense aptitude for research and
development work, Ms. Neharika is a work-driven spirited member of the IGMPI team. She has
completed her B.Sc. in Food Technology from Delhi University and M.Sc. in Food Science and
Technology from Pondicherry University. Ms. Neharika has qualified UGC NET in Home Science and
ICAR NET in Food technology multiple times. Being an active member of the research community, she
has authored a few research publications in international journals and her work with “Utilization of
deoiled peanut cake in bakery products” is particularly noteworthy. With her sporty spirit and
resolution to leave no work incomplete, she is a constant source of inspiration for the students as well
as faculty members. Prior to joining IGMPI she has worked as Assistant Professor in ITM University,
Gwalior and had research exposure at ICAR institute. At IGMPI, she is involved in lecture delivery and
research guidance while conducting interactive sessions with the students.
Ms. Sangita Borah, Assistant Professor: Ms. Sangita is a competent professional with experience in
biochemical studies, food quality testing, equipment handling, and research & development. As a part
of Faculty of Food Safety and Quality, she is responsible for developing training module, lectures and
research in the domain of food processing and technology. She has qualified ICAR-NET in Food
technology and her academic credentials include Masters in Food Processing and Technology from
Tezpur University, Assam and graduation in Biotechnology from Shillong. She has always been a keen
participant of international conferences, seminars, and workshops in the field of food safety and
quality improvement of food supply chain. Prior to joining IGMPI, she has worked as Research Analyst
in Rai University and Sr. Research Fellow (SRF) in Tezpur University.
Ms. Akanksha Bhandari, Assistant Professor: As a young trainer, known for her vibrant presence and
unmatched dedication towards work, She has taken the responsibility of imparting a whole new
meaning to IGMPI’s resolution of knowledge dissemination. Ms. Bhandari is a B. Pharm, M. Pharm
qualified professional from Punjabi University with a Certification in Intellectual Property Rights. She
has an impressive hold over the concepts of pharmacovigilance, clinical research, regulatory affairs,
good manufacturing practices and is proficient in handling of sophisticated equipments. Her areas of
interest include Patent searching, drafting, & writing specifications, Novel drug delivery systems, and
Modified release oral dosage forms (Formulation Optimization). Her industrial exposure encompasses
IDS Infotech and BRD Medilabs for production and analysis of oral liquids and tablets. Prior to IGMPI,
She has worked at Galgotias University, Department of Pharmacy as Assistant Professor.
Mr. Joshua Martin, Assistant Professor (Food Technology): Joshua has an important role in the
development of the course content and training modules. His field of interest is food safety, FSMS,
GMP, HAACP & other standards and food packaging. He has a rich exposure to a variety of Food
Industries as a consultant in terms of Food Safety. He is an M.Tech in Food Technology with
specialization in Food Process Engineering from SHIATS-DU, Allahabad. Prior to joining IGMPI he was
also associated with Nestle. He is a FSSC 22000 certified lead auditor from SGS, India.
Ms. Bhawna Sharma, Assistant Professor: Bhawna is working with IGMPI in the development of
training modules, lectures and assisting the senior faculty members in teaching, training and research.
She is having technical competence and interest in the field of Clinical Research, Good Manufacturing
Practices and Pharma Product Management. She has completed M. Pharmacy with specialization in
IGMPI
Pharmacology from P.D.M. College of Pharmacy, PGIMS University, Haryana and B. Pharmacy from
Hindu College of Pharmacy, PGIMS University, Haryana.
Ms. Nisha Rani, Assistant Professor and Programme Co-ordinator: She is involved in the development
of training modules, lectures and assisting the senior faculty members in teaching, training and
research. She has technical competence and interest in the field of Regulatory Affairs, Intellectual
Property Rights and Good Manufacturing Practices. She has completed her B.Pharmacy and M.
Pharmacy with specialization in Drug Regulatory Affairs from Maharishi Dayanand University, Rohtak,
Haryana and qualified GPAT, 2012.
Ms. Garima Mishra, Assistant Professor: With a good hold over pharma subjects, impressive
interaction skills and a sincere learning attitude, Ms. Garima has teamed up with the IGMPI staff in
preparation of modules and lecture development. She has keen interest in Organic chemistry,
Medicinal Chemistry & Pharmaceutical analysis and taken lectures on the subjects in reputed pharma
colleges. Her industrial exposure encompasses Akums Pharmaceuticals Pvt. Ltd, Ind-Swift, UNICHEM,
Alembic and others. She has completed B. Pharm and M. Pharm (Pharmaceutical Chemistry) during
her academic tenure. She has various research papers published to her name in Asian Journal of
Pharmaceutical and Clinical Research, International Journal of Pharmacy & Life Sciences and
International Journal of Medicinal Chemistry and Analysis and many others on the way. She has
published a book named “Method development and validation by Gas chromatography”, and co-
authored “Dissolution Enhancement Using Different Formulation Approaches” and Lap Lambert
academic publishing (USA).
Ms. Geetanjali Rai, Programme Coordinator: Ms. Geetanjali is a highly experienced professional with
excellent administrative skills. At IGMPI, she is mainly responsible for setting up effective systems and
processes for smooth execution of administration work. She is a multi-tasker with experience in
providing Management, Marketing as well as Administrative support to all parts of the work. She is
known for a consistent ability to accurately maintain computerized and manual filing/ documentation
systems along with answering and resolving queries precisely, in a courteous and confident manner.
She has earned proficient skills from her tenure at Max Hospital, Lupin Pharmaceuticals Ltd. and
Streatham Place Surgery, London, UK.
Ms. Bhavna Khattar, Programme Co-ordinator: Bhavna's key role is to assist our Advisors in the
coordination and execution of our programmes and training modules. She also has good interest in
academic deliverables and research in the areas of Good Manufacturing Practices, Quality Assurance
and Quality Control, and Regulatory Affairs, IPR etc. She has completed B. Pharmacy from Jaypee
University, Solan. Prior to joining IGMPI, she was working with Bioplasma Immunologicals Research.
Ms. Satarupa Ghosh, Programme Coordinator: She has completed B.Sc in Biotechnology Hons. from
Royal School of Management and Technology, Utkal University, Bhubaneswar, Odissa and M.Sc. in
Biochemistry from Boston College for Professional Studies, Jiwaji University, Gwalior. She has done
specialized training related to HLA B27 typing and possesses hands-on skills on other routine
diagnostics in Molecular diagnostic division learnt from SRL Religare Laboratories, Gurgaon. She has
also done PG. Diploma in Clinical Research from Hyderabad. Presently, her role in IGMPI encompasses
development of training modules providing assistance to senior members of the staff.
Mr. Deepanshu Soni, Technology Officer: With a rich experience in Software Development, Web
Development, application development, Deepanshu works as a Technology Officer and is responsible
for all the technical works and new initiatives at IGMPI in order to make our Learning Management
IGMPI
System (LMS) and other web services to our training participants and students user friendly. He also
possesses technical competence and interest in the areas of code development, web design etc. He
has completed his B. Tech in Information Technology (I.T) from Vindhya Institute of Technology and
Science, R.G.P.V University, Bhopal.
Ms. Rafat Abedi, Director: Rafat Abedi is our Investor & Director. She has been investing in this
nonprofit making organization with the primary objective of knowledge dissemination in Good
Manufacturing Practices. She looks after administration of IGMPI, training co-ordination, training kits
and study materials development and entire logistics for IGMPI. She has previous rich experience in
education, training and co-ordination of computer application and management programs.
Mr. Syed S. Abbas, Director: Owing to his academic achievements and interests Syed Abbas has gained
work knowledge of several sectors of the business industry, in his career span of twelve years. His
contributions to the Pharma and healthcare industries development studies are numerous. Some of
the generous ones count around the esteemed projects, work models, business agendas and
organisational setup works he has plotted, guided and worked for in the education and Training
Industry, Information Technology industry, Pharmaceutical Research Industry, non-governmental
organizations, and many others. He has completed Masters in Public Administration from Lucknow
University and Executive MBA from Indian Institute of Management (IIM), Lucknow. He is a member
of Indian Pharmaceutical Association (IPA).
As an operations head of IGMPI, he with his experience has been guiding and advising sincerely to
bring forth a whole new bouquet of easy learning and training tools for all those using or planning to
use or otherwise interested in gaining knowledge about Good Manufacturing Practices.
ADVISORY FACULTY FROM INDUSTRY

Apart from regular faculty members, eminent and dynamic industrial professionals having rich
industrial experience of upto 35-40 years have got associated with IGMPI in regular, part-time,
distance cum e-learning and Continuing Education Programme (CEP).The industrial professionals who
have joined IGMPI in this initiative have worked in reputed pharmaceutical companies like Ranbaxy
Laboratories Ltd,Cadila Pharma Ltd, Dr.Reddy's Laboratories,Quintiles,IPCA, Cipla etc in the areas of
GMP,GLP, Clinical Research, QA/QC, IPR, Regulatory Affairs, Drug Discovery, Public Health, Medical
Coding etc.The continuing education training programme has been launched with an initiative to
provide training to work force in the industry on specific topics in short time period and to quick fix the
issues with possible solutions by having an interface with senior industrial professionals.
IGMPI
Certificate Programmes in
GMP for Finished Pharmaceuticals & For Manufacturing,
Processing, Packing, or Holding of Drugs.
Personnel in pharmaceutical industry should be familiar with the basic GMP requirements and
become familiar with technical terms from the field of GMP and their meaning. The course is directed
to staff from the pharmaceutical industry having less exposure to current GMP requirements. This
includes both employees who are fresher in pharmaceutical industry and experienced colleagues who
work for the first time in a GMP-regulated environment.
The case study based approach in certificate programme via distance cum e learning mode is designed
for working professionals in full time employment who want to update their knowledge and gain
required skills in the area. This course is beneficial for professionals from different streams to help
them intensify their knowledge. This is an advanced course having rigorous case studies based
methodology throughout the duration. The training in GMP imparted by IGMPI is approved and
certified by Quality Council of India, Government of India.
IGMPI Certified Modules

Module 1 : Basic Principles of Good Manufacturing Practices
Module 2 : Good Manufacturing Practice for Finished Pharmaceuticals and for Manufacturing,
Processing, Packing, or Holding of Drugs
Module 3 : Complaint Handling and Product Recall
Module 4 : Deviation Management, CAPA And Change Control
Module 5 : The Indian GMP Regulation
Module 6 : Computer System Validation
Module 7 : Importance and Principle of Data Integrity
Module 8 : Case Studies
Future career prospects of the programme

GMP and its applications are not restricted to manufacture of solely pharmaceutical drugs but extents
to variety of other consumer products. GMP is the only and the best tool to ensure production of
quality safe products. So knowledge of the same could help those aspiring to join industry or those
targeting to set up one such manufacturing unit. After completion of this course, professionals can
work as production manager, production executive, production officer, production team leader.
IGMPI
GMP in Manufacturing, Packing or Holding of Human Food

Good manufacturing practices (GMP) are essential to any organization looking to reduce the risk and
liability that can result from poor handling within a food operation. This programme come across
common dangers associated with manufacturing. This programme helps in management of
organization's processes and ensuring complete control over general hygiene procedures and
environmental contaminants. This course is beneficial for professionals from different streams who
wants to start their stint in food sector or interested in updating their knowledge. Improved
knowledge of GMP, Enhanced ability to identify potential food safety risks from GMP, Correct
implementation of GMP and Compliance with global best practice are some of the benefits of
programme.
methodology throughout the duration. The training in GMP imparted by IGMPI is approved and
certified by Quality Council of India, Government of India.

Module 1 : Introduction to GMP and Food Industry
Module 2 : Indian Food GMP
Module 3 : GMP in manufacturing, packing or holding of human food
Module 4 : Validation and Verification for Food Industry
Module 5 : Conducting and facing first, second & third party audits
Module 6 : Complaint Handling and Product Recall (Food Industry)
Module 7 : CAPA and Deviation management (Food Industry)
Module 8 : Industry based case studies.

From health care product manufacturing to biotech products, food and beverage manufacturing, GMP
is the only best tool to ensure production of quality safe products. This certificate programme provides
adequate knowledge for more specialized roles like quality manager, food safety officer, production
executive, food safety standards consultant and many more. After completion of this course,
professionals can work as production manager, production executive, production officer, production
team leader.
IGMPI
Food and Drug Regulatory Agencies

This program is intended to provide with a basic understanding of the areas of regulatory affairs and
quality operations to give a thorough and up-to-date knowledge of food and drug regulatory agencies
as they apply to all stages of the development and commercialization of pharmaceutical,
biopharmaceutical, medical device and food products. The programme aims to equip the participants
with the educational foundation that will help them advance in the regulatory affairs profession. The
course will provide the fundamentals required in regulatory affairs.
methodology throughout the duration.

Module 1: Regulatory agencies for Food (International perspective)
Module 2: Regulatory agencies for Drugs (International perspective)
Module 3: Regulatory agencies in India
Module 4: Regulatory Compliance requirements in India and other major markets
Module 5: Industry specific case studies

The regulatory affairs market has always been of a fluid nature due to the constant changes in
regulations in the world and Regulatory adherence is imperative for obtaining and maintaining
marketing authorization. The knowledge gained from this course regulatory affairs is essential for
continued success of pharmaceutical and food industries within the world to get approval and
authorization. The course will empower the students with the tools required to successfully navigate
the minefield i.e. GCC, FDA, TGA, EU and other regulatory affairs compliance systems. The course will
ensure that participants are completely up to date with the latest in legislation. These courses equip
the participants with the knowledge and confidence to instigate the optimization of the in-house
regulatory procedures. After completion of this course, professionals can work as regulatory
associate, regulatory officer, documentation analyst, documentation specialist.
IGMPI
Process Analytical Technology

This course provides an overview of PAT applications in pharmaceutical operations. At the end of the
course, participants will get to know the PAT life cycle, PAT applications likely to yield positive benefit,
understand issues of organizing and managing a PAT project and integrating the principles of Quality
by Design into the effort.
Process analytical technology (PAT) is becoming a very important tool for controlling pharmaceutical
processes and when implementing Quality by Design. This course is designed to help pharmaceutical
manufacturing professionals chart a new course for innovation based on PAT.

Module 1 : PAT Vision and Framework
Module 2 : PAT in Development, Manufacturing, Automation control system, Quality by design,
Process validation etc.
Module 3 : Introduction to Quality by Design (QbD)
Module 4 : Technology Identification and assessment
Module 5 : Industry based Case Studies

Process Analytical Technology is becoming a very important tool for controlling pharmaceutical
processes and while implementing quality by design. This course provides an overview to the tools and
principles outlined in the FDA guidance. This course is very useful for professional engineers, scientists
and managers involved in pharmaceutical drug substance or drug product manufacturing and
development, quality assurance and regulatory affairs. After completion of this course, professionals
can work as analytical development scientist, quality technician, and analytical PAT scientist.
IGMPI
Documentation in QA & QC Department

This course has been designed to impart knowledge and practical understanding about the quality
assurance department and quality control department with special emphasis on documentation. This
course utilizes tools to guide each participant through the steps of quality assurance working and
managing quality documentation procedures in pharmaceutical companies.
methodology throughout the duration. The training in Quality Assurance and Quality Control
imparted by IGMPI is approved and certified by Quality Council of India, Government of India.

Module 1 : Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare
industries
Module 2 : Role of QA & QC and Good Documentation Practices
Module 3 : Quality Documentation: Requirement and Industry Expectations
Module 4 : Industry based Case Studies

QA and QC are quiet essential parts of pharmaceutical, biotech and all other verticals of the healthcare
industry. The course utilizes tools to guide each participant through the steps of quality assurance
working and managing quality documentation procedures in pharmaceutical companies. This course
is beneficial for professionals from different streams to help them intensify their knowledge. After
completion of this course, professionals can work as documentation analyst, documentation
specialist, quality manager, quality analyst.
IGMPI
Registration of Drug and Dossier Preparation (CTD and e CTD

submission)
This course takes through the essential steps for submitting electronic submission to the regulatory
agencies and Research (CDER) and can serve as a resource for questions about the submission process.
The eCTD format has become mandatory in key markets for electronic submissions. This course, while
focusing on the US requirements, also provides a quick overview of current regulatory guidelines of
eCTD in major world market including North America, the European Union etc. It aims to introduce
tools to assist the participants in formulating effective strategies in the development, compilation, and
submission of US-compliant eCTDs
This course is designed for professionals of the biotechnology and pharmaceutical industries who are
currently, or planning to become, involved in the development of regulatory submissions using the
electronic Common Technical Document (eCTD). The program is particularly suitable for project team
members interested in gaining a practical understanding of regulations, tools, and required
submission processes. This includes professionals working in Regulatory Affairs / Regulatory
Operations, Submissions Management, Authors of CTD Sections, Technical and Clinical Writers,
Documentation Teams, Project Management and Information Technology and Information Systems.

Module 1 : Market authorization & electronic submission in major markets
Module 2 : Registration of Drug and Dossier Preparation (CTD and e CTD submission)
Module 3 : Drug Registration, CTD and e CTD submission in India.
Module 4 : Industry specific case studies

This course provides a comprehensive description on the Common Technical Dossier structure -
completely updated to reflect the latest changes in pharmaceutical regulatory affairs. After
completion of this course, professional will be able to identify the recent requirements for developing
drug substance and drug products and setting up a registration dossier. After completion of this
course, professionals can work as regulatory associate, regulatory officer, documentation analyst,
documentation specialist.
IGMPI
Drug Registration (European Market)

This programme provides a comprehensive description and discussion of the regulatory environment.
The Comprehensive Training on European Regulatory Affairs including different Registration
Procedures and Variations. This is a unique opportunity to learn, understand and discuss the main
aspects of drug regulations in Europe directly from key European Regulators and from the large
experience in the pharmaceutical industry and to acquire key recommendations for a successful
implementation of regulatory strategy and operations.

Module 1 : Drug Registration in Europe
Module 2 : Comparison of Drug Approval Process in US and Europe
Module 3 : Dossier preparation in CTD Format, eCTD Submissions

The objective of these courses is to impart knowledge and practical understanding about the drug
registration procedures that are available and the structure of the registration dossier. Professionals
who are willing to have a successful career in regulatory affairs, registration and documentation for
European Countries, GCC Countries, India, US market should attend this course. These courses are
highly recommended for those who are aspiring to move into regulatory affairs from other areas
within a pharmaceutical company. After completion of this course, professionals can work as
regulatory associate, regulatory officer, documentation analyst, documentation specialist.
IGMPI
Drug Registration (GCC countries)

The Gulf Cooperation Council (GCC) region is considered as “Emerging market” for pharmaceutical
export and bilateral trade. The course has been designed with the view to impart knowledge and
understanding of Drug Registration Procedure in GCC countries, Regulations, Registration procedure,
country specific Common Technical Documents, GCC guidelines and dossier preparation.

Module 1 : Introduction to Global Regulatory Authorities for Pharma industries
Module 2 : Overview of the GCC countries and Drug Registration
Module 3 : Registration of Innovative Pharmaceutical Products in GCC countries and submission
of dossier
Module 4 : Pharmaceutical Import & Export Procedures in Gulf Countries

IGMPI
Drug Registration (African countries)

The objective of this course is to impart knowledge and understanding of Drug Registration Procedure
in African countries - Regulations, Registration procedure, Country specific Common Technical
Document guidelines and dossier preparation. Course includes hands on training on country specific
dossier preparation. This course utilizes interactive learning tools to guide through the steps of drug
regulation and registration process for the African countries.

Module 1 : Introduction to Global Regulatory Authorities for Pharma and Pharma industries
Module 2 : Overview of the African countries and Drug Registration
Module 3 : Registration of Innovative Pharmaceutical, biotech Products, Generic and
Biosimilar products in African countries

IGMPI
Drug Registration (India)

This course provides integrated knowledge and broad perspectives required to effectively manage the
regulatory process for approval of new drugs in India. This course targets all Pharma
manufacturer/importer, regulatory, preclinical, formulation scientists, and clinical trial professional
who are involved directly or indirectly in new drug registration process. The course modules covers
new drug including fixed-dose combination in India. Ever-changing laws and regulations require
regulatory affairs professionals to cater the current needs of industries for the global competition so as
to effectively bring their medicinal products to the Indian market with less time.

Module 1 : Regulatory Overview in India and Regulatory Dossier
Module 2 : Registration of Drug in India
Module 3 : Drug Registration, CTD and e CTD submission in India.

IGMPI
Drug Registration (US Market-ANDA, NDA etc)

This course targets the training needs of executives who are or will be involved in the preparation of
development plans and/or registration dossiers. Tougher regulatory approval processes pose
challenges for pharmaceutical companies registering drugs in the USA.
This certificate course develops understanding of all the current procedures in the challenging
environment of US. By attending this 1 month programme, practical insight will be gained into FDA's
requirements for new drug development and preparation of new drug registration dossier accordingly
to US guidelines. This course will provide benefit in terms of:
 Faster drug registration in the US.
 Needs, expectations and regulatory requirements of the FDA for the drug registration dossier
 Preparation of successful Investigational New Drug Applications (INDs) & New Drug Applications
(NDAs)

Module 1 : Drug Registration in USA
Module 2 : IND, NDA and ANDA submission

IGMPI
Preparation and Submission of Drug Master File (DMF)

This course is designed for professionals to provide an understanding of the role DMFs play in the FDA's
regulatory approval process for drugs and biologics. This course will explain step-by-step process of
DMF preparation and explain the types of information essential for any Drug Master File. This will be of
great benefit to regulatory compliance professionals working on DMF, NDA, IND or ANDAs, Regulatory
affairs professionals, attorneys, project managers, and management professionals in small and mid-
size manufacture operations.

Module 1 : Drug development process and regulatory filings
Module 2 : Introduction to Drug Master Files and its Types
Module 3 : Preparation and Submission of Drug Master File

The DMF summarizes the essential elements pertaining to facilities, processing, manufacturing
components, packaging and storage for products associated with pharmaceutical product
development. Attendees will learn the differences between the five types of DMFs and the detailed
information required within each type of DMF. Using a series of case studies, the course will highlight
real word examples and actual experiences with FDA submissions related to DMF components. Upon
completion of the course, attendees will be able to begin developing or to improve upon their DMF file
documentation. Professionals working in manufacturing, Regulatory affairs, research and
development, QA and QC, validation and development and preparation of submission material will be
highly benefited by this course. After completion of this course, professionals can work as regulatory
associate, regulatory officer, documentation analyst, documentation specialist.
IGMPI
Prescription to OTC switch

Self-care is becoming increasingly popular among health care consumers. Due to the availability of
over-the-counter medications it is possible to treat numerous ailments without the supervision of a
health care professional. This course is designed to provide sufficient education regarding the safe and
effective use of over the counter products.

Module 1 : Introduction to Prescription to OTC switch
Module 2 : Regulation on Prescription to OTC switch

Accelerated OTC market growth will also come from greater consumer involvement in self-treatment.
Healthcare is costing more out-of pocket to the consumer. This encouraged consumers to seek out
information and more knowledgeably select and purchase the lower-priced OTC alternatives. By
opting for this course, the candidate will have better knowledge of OTC medication and their safe use
and supporting regulation and can work as regulatory associate in the team working in this area. After
completion of this course, professionals can work as product manager, product management director.
IGMPI
Computer System Validation

Computer validation is more than a compliance requirement. It not only reduces regulatory risk, but it
also increases understanding of system during project implementation and enforces a structured,
well-defined execution of the project. Pharmaceutical Computer System Validation is a unique
opportunity for a business to examine their computer systems to maximize effectiveness and enhance
quality, with the potential to save cost and time. Subject matter expert (SME) of CSV will have a major
role in achieving these benefits. This course will be of benefit to anyone involved in FDA audits and
Computer Systems Validation (CSV) on both a domestic and global scale. Additionally, this course will
be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement,
R&D, Commercial, Quality Control and other job functions which are impacted by CSV efforts. This
course is particularly useful to those who interface with vendors, FDA and other regulatory agencies.

Module 1 : Qualification & Validation
Module 2 : Computer System Validation (CSV) - Overview, Regulatory requirements (GAMP &
21 CFR Part 11) and documentation
Module 3 : Software Quality Audit -Implementation in Life science verticals
Module 4 : GAMP 5 and documentation
Module 5 : Importance and Principle of Data Integrity
Module 6 : Case Studies

Companies, particularly the life science industries
must validate their information technologies
(such as computer systems, software that run on
them and infrastructure components) to ensure
they meet the intended business needs.
Computer System Validations involve activities
primarily around generating requirements and
specification documents, testing the systems
against those specifications, documenting test
results and writing final reports. There is
definitely a bright career path if one is willing to
learn about personnel process and technologies.
Computer System Validation field had enjoyed an explosive growth since the early 90’s. IT
professionals, software vendors and developers, research, development and manufacturing
associates and scientists, healthcare and clinical professionals, quality management professionals and
technical project managers are dedicated to this field and the need is steadily growing as technology
evolves and regulations increase. After completion of this course, professionals can work as computer
system validation specialist, validation engineer, validation consultant/analyst, QA consultant, IT
validation analyst.
IGMPI
Pharmaceutical Validation
This Certificate Programme has been designed to help manufacturers gain awareness of quality
requirements regarding validation and the nature of “special processes”. This programme targets
Quality, Product Development and Manufacturing personnel involved in process validation,
Regulatory Affairs Managers and auditors of manufacturing firms (internal and external).
This certificate reduce development time with better understanding of validation, faster market
access with more compliant products, Increase sales and customer satisfaction with professional
development and knowledge sharing. The validation programme is ideal for anyone in the
Pharmaceutical, Medical Device, Biotech, Biopharmaceutical and Skin/Cosmetic industries who is
tasked with validation.
The case study based approach in certificate programme is designed for working professionals in full
time employment who want to update their knowledge and gain required skills and attitude in the
area in order to become a certified GMP professional in the domain. This certificate is also beneficial
for professionals from different streams to help them intensify their knowledge. This is an advanced
certificate having rigorous case studies based methodology throughout the duration.

Module 1 : Quality, Quality Assurance and Quality Control
in Pharmaceutical and Healthcare Industry
Module 2 : Introduction to Validation
Module 3 : Validation: Ins and Outs
(FDA and WHO perspectives)
Module 4 : Quality Control checks, Inspections and Audits
Module 5 : Government Regulations and Certifications,
ICH guidelines and ISO 9000
Module 6 : Computer System Validation
Module 7 : HVAC Systems Validation

This course is relevant to individuals working throughout the pharmaceutical product lifecycle
in development, manufacturing, quality, and many other roles involved in validation of products
and processes. It will help them to integrate and link the science and risk-based lifecycle
approach for Validation to your Pharmaceutical Quality System. Validation professionals evaluate
and calibrate the equipment and procedures used in development and production of a variety of
products. They ensure all systems are running according to necessary specifications and operate
within regulations to ensure the production of quality products. After completion of this
course, professionals can work as validation specialist, validation engineer, validation analyst.
IGMPI
Computer Aided Drug Design (CADD)

Drug, discovery and development is an intense, lengthy and an interdisciplinary endeavor. The
contribution of computational methodologies has revolutionized the process of drug discovery. It is a
powerful tool in the study of relationship between molecular structure and biological activity and thus
essential in the process of rational drug design. Now days, major world’s pharmaceutical and
biotechnological companies use computational design tools. This Computer Aided Drug Design course
covers all main computational techniques used in drug discovery, supplying a basic level of knowledge
of this research field. This technique will provide a unique platform to all researchers working in this
field to screen new drug entities.

Module 1 : Concepts and Principles in CADD – 2D and 3D QSAR
Module 2 : Molecular Modeling and Pharmacophore
Module 3 : Virtual Screening and Molecular Dynamics
Module 4 : Molecular Docking
Module 5 : Advanced Concepts in Bioinformatics: Homology
Module 6 : Proteome based Technology: Concepts, Principles and Application

Drug design, through computer, is a most recent, exceptionally viable strategy in present day field.
Computer Aided Drug Design (CADD) could be utilized for generation of effective drug agents
(inhibitor) against disease (target). As a result of this, a large number of candidate drugs have been
developed till now. This course is very helpful for those professionals who are interested in making
their career in the field of drug, discovery and development and research industry. After completion of
this course, professionals can work as research scientist, CAD designer, design technician.
IGMPI
Good Clinical Practices (GCP)

Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all
clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety
and wellbeing of research participants are protected and that research data are reliable. This
certificate programme is aimed at improving the conceptual knowledge of the participant for Good
Clinical Practices and resolving any dilemmas that a working professional may face regarding the
application of GCP guidelines at his workplace. Successful performance in this exam implies that the
participant has in-depth knowledge and clear understanding of industry guidelines and regulations.
The study material has been carefully designed to introduce the attendee to various aspects and basics
of GCP, its need and benefits in assuring the ethical and scientific integrity of clinical trials.GCP
compliance provides assurance that the rights, safety and well-being of trial subjects are protected,
and that the results of the clinical trials are credible. Several specialized topics have been added to
guide the participant through ICH GCP regulations, compliance needs, comparison of Indian GCP
guidelines vs. ICH GCP guidelines etc.

Module 1 : Introduction to Clinical Trials
Module 2 : Overview of ICH- GCP Guidelines and its new revision
Module 3 : Principles of ICH GCP- Responsibilities, Sponsor, Investigator and Ethics Committee
Module 4 : Essential Documents- Informed Consent, Protocol and Investigator's Brochure
Module 5 : SAE Reporting, Audit & Inspection
Module 6 : Consequences of GCP non-compliance
Module 7 : GCP Guidelines for Medical Devices

Pharmaceutical professionals need to ensure that their skills should be up-to-date with the latest
regulations. The good clinical practice guidelines ensure that clinical trial participants are protected
during the research process. This certificate course will help professionals, strengthening their skills
and experience in this field.
IGMPI
Analytical Testing and Equipment

Analytical testing is a very important component of quality testing and validation of pharmaceutical
products. In a pharmaceutical laboratory, a lot of work is being done on analytical equipments. Thus
workforce trained in handling such equipments is always in demand. IGMPI offers an opportunity to
act as a trained technician handling such equipments.

Module 1 : Introduction to Pharmaceutical Analysis
Module 2 : Analytical Testing and its Scope
Module 3 : Basics of Spectroscopy
Module 4 : Basics of Chromatography
Future career prospects

Analytical testing is an essential part of pharmaceutical, biotech and all other verticals of the
healthcare industry. The course is more profitable for the person who wants to make their career in
various industries which works with pharmaceuticals, chemicals, cosmetics, and analytical testing
laboratories, etc. This course has been tailored to suit the needs of employed as well as yet to be
employed candidates targeting to take over the analytical division of the industry.Job roles and
positions like that of laboratory assistants or technicians in reputed pharmaceutical companies.
IGMPI
Certificate in Sterile Manufacturing

Within the framework of pharmaceutical production, the most demanding requirements apply to
sterile manufacturing and aseptic production because this is the most critical process for the
manufacture of medicinal products. Sterile manufacturing is an important aspect of pharmaceutical
industries as there are certain pharmaceutical products that cannot be produced/ sterilized by the
normal processes. In order to better understand the process and its intricacies, students can pursue
this course from IGMPI to gain access into the sterile product sector in pharmaceutical industry.

Module 1 : Sterile pharmaceutical products and their Formulation
Module 2 : Requirements for Sterile Product Manufacturing
Module 3 : Sterilization process
Module 4 : Clean-room design, qualification and operation
Module 5 : Quality Testing and Control
Module 6 : Vaccine manufacturing processes
Module 7 : Regulatory standards for sterile products

This course is intended for those having specific responsibilities or wants to make their career in the
area of sterile manufacturing. It will be of particular value to those in research, development,
production, quality assurance and control. Job roles and positions like that of shop floor level
production assistants or technicians in reputed pharmaceutical companies, cosmetic manufacturing
units, wherever production of such specialized products like parenterals and opthalmic preparations is
being carried out.
IGMPI
Certificate in Naturopathic Science

There is an increasing demand for medicines from traditional systems in developing as well as
developed countries because of their being into existence since a very long time thereby
enjoying the reputation of being both safe and efficacious. Naturopathy is a field of health care
that works with, and not against standard allopathic health care providers, such as medical
doctors. The philosophy of Naturopathy is to work with the body, to assist it in its natural ability
to heal and maintain health. Treatments are natural and non-invasive and include herbal
remedies, lifestyle changes, and dietary modifications and in some cases other complementary
techniques including massage, acupuncture or aromatherapy.
Naturopathic practitioners focus on the work closely with the patient’s own unique set of
symptoms, reactions and status. Natural health plays an important role for the holistic
development of the personality. It is utmost important to have technical and scientific
knowledge of all the components such as hydrotherapy, chromotherapy, diet therapy, magnet
therapy etc. for promotion and preservation of health.

Module 1 : Human Anatomy and Physiology
Module 2 : Foundation of Naturopathy
(Health, Nutrition & Yoga)
Module 3 : Indian System of Medicine
Module 4 : Biochemistry
Module 5 : Disease & Treatment by Naturopathy
Module 6 : Extraction, Isolation and Analysis of Phytopharmaceuticals
Module 7 : Screening and Standardization of Herbal drugs
Module 8 : AYUSH Regulatory Affairs
(Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy)
Future career prospects of Naturopathic Science

The ultimate goal of the Naturopath is to gradually and gently improve a patient’s health, enabling
and motivating them to make lifestyle changes that they can maintain long term. Treatment is
aimed at the illness causing symptoms, not at masking the individual symptoms themselves. The
body is treated as a whole, the physical, emotional and mental aspects are all catered for. The
naturopathy professional can opt different fields as per their choice, interest, expertise and
knowledge. Some of the important broad disciplines where the naturopathic doctors can consume
themselves inHospital and Healthcare Administration, Health Supervisor, Naturopathy
Consultation as instructor, expert, specialist, etc.
IGMPI
Certificate programme in Quality by Design

The certificate covers all the statistical tools for QbD framework. The certificate features with industry
specialists and experts facilitating quality implementation in various industries. QBD implementation
can give manufacturers much more confidence in the robustness of their product, potentially
increases the efficiency and quality of their development and manufacturing process as well as
reduces profit leakages.
This certificate will provide insight into the key principles of QbD covering quality risk management
and formal experimental design. The certificate is intended as continuing professional development
(CPD) for professionals in the pharmaceutical industry, particularly in production, regulatory affairs
and quality functions. The certification will offer an excellent introduction for those less familiar with
QbD and provide those with more experience with QbD, new ideas on how to further implement the
QbD programme.
The case study based approach in certificate programme is designed for working professionals in full
time employment who want to update their knowledge and gain required skills and attitude in the
area in order to become a certified GMP professional in the domain. This certificate is also beneficial
for professionals from different streams to help them intensify their knowledge. This is an advanced
certificate having rigorous case studies based methodology throughout the duration. The training in
QA & QC imparted by IGMPI is approved and certified by Quality Council of India, Government of India.

Module 1 : Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare
industries
Module 2 : Introduction to Quality by Design (QbD)
Module 3 : QbD Methodology and its Implementation
Module 4 : PAT Vision and Framework
Module 5 : PAT in Development, Manufacturing, Automation control system, Quality by
design, Process validation etc.
Module 6 : Technology Identification and assessment

Across all types of industry, quality engineers are at work monitoring, testing and inspecting products
to make sure they meet specified standards. Quality engineers test products to determine how long
they will last, what part may break down first and how to improve product durability. The quality
engineer also designs systems by which production quality can be checked in an ongoing process. In
addition, quality engineers typically work with the production team to implement any new testing
criteria or assembly methods they may have developed.
IGMPI
Certificate programme in Chemical Safety

The objective of the Chemical Safety programme by IGMPI is to impart training on how to identify
chemical hazardous areas and where they exist around the facility. Personnel that will bring chemical
hazards to the facility or engage in hazardous chemical work also need to complete the extended
chemical safety training.
Chemical Safety is achieved by undertaking all activities involving chemicals in such a way as to ensure
the safety of human health and the environment. It covers all chemicals, natural and manufactured,
and the full range of exposure situations from the natural presence of chemicals in the environment to
their extraction or synthesis, industrial production, transport use and disposal.
Chemical safety has many scientific and technical components. Among these are toxicology,
ecotoxicology and the process of chemical risk assessment which requires a detailed knowledge of
exposure and of biological effects.
Chemical hazards and toxic substances pose a wide range of health hazards (such as irritation,
sensitization, and carcinogenicity) and physical hazards (such as flammability, corrosion, and
explosibility). So we will learn here how to prevent ourselves from hazardous chemicals and what &
which equipment should be used for various types of chemicals.

Module 1 : Chemical Hygiene and Safety
Module 2 : Handling of Hazardous Chemicals
Module 3 : Process safety Management (HAZOP Study & Risk Assessment)
Module 4 : Engineering, Installation, Commissioning, validation & Continuous improvement
Module 5 : International Guidelines for Chemical handling (WHO,EFHS, EHS, OSHA, FDA)
Module 6 : Chemical Safety for various Industries like Pharma, Food, Petrochemical, Pesticides,
Fertilizers etc.
Module 7 : Various industrial case studies

Chemical Safety provides a strong focus on prevention from chemical hazards, toxic substances &
physical hazards and use of green chemistry. You will learn the techniques for problem solving, risk
analysis as well as managerial and practical application of knowledge to particular fact scenarios
through a number of advice drafting exercises and also learn here how to prevent ourselves from
hazardous chemicals and what & which equipment should be used for various types of chemicals.
Chemical Safety is important in extending benefits of R&D, Production and engineering to the society
at a large, especially in developing countries.
IGMPI
Certificate programme in HVAC Systems Validation

Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring the manufacture
of quality pharmaceutical products. Well-designed HVAC systems will also provide comfortable
conditions for operators. HVAC systems account for as much as two-thirds of the energy usage in
pharmaceutical facilities, system design and critical parameter selection for efficiency will be explored
for all facility types. This course describes the HVAC simulation-based validation methodology,
performance validation of HVAC systems, energy analysis of HVAC systems and other related factors
involved with system simulations.

Module 1 : Introduction to Pharmaceuticals cGMPs (US FDA & WHO)
Module 2 : Pharmaceutical HVAC Rules and Design
Module 3 : HVAC Qualification (DQ, IQ, OQ, PQ) and Calcification
Module 4 : HVAC Commissioning and Testing
Module 5 : Validation of HVAC Systems
Module 6 : HVAC Audit and Inspection

Heating, Ventilation, Air Conditioning (HVAC) play an important role in ensuring the manufacture of
quality pharmaceutical products. HVAC design engineers usually work for consulting or design
companies. They focus on solving problems related to air quality issues, environmental issues or
energy efficiency.
After completion of this course, professionals can work as HVAC validation specialist, HVAC validation
engineer, HVAC validation consultant/analyst, HVAC Engineer.
IGMPI
Certificate programme in WHO-GMP

GMP is a critical concept in pharmaceutical industry. According to World Health Organization (WHO),
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced
and controlled, according to quality standards. Main aim of this is to minimize risk involved in
pharmaceutical manufacturing which is difficult to eliminate through testing the final product. Serious
consequences may take place in absence of these standards such as License may get cancelled,
product may be banned or charged for negligence/ non-compliance.
This Certificate programme bestows each interested working professional with long lasting benefits.
This raises awareness among the key (responsible) people about the benefits of following GMPs and
correct procedure to get GMP approval so as to introduce product in market successfully. This
certificate is also beneficial for professionals from different streams to help them intensify their
knowledge. This is an advanced certification having rigorous case studies based methodology
throughout the duration.

Module 1 : Basic Principles of Pharmaceutical Good Manufacturing Practices
Module 2 : WHO-GMP
Module 3 : Certificate of Pharmaceutical Product (CoPP)
Module 4 : HVAC Systems Validation (WHO Perspective)
Module 5 : Risk-based approach to GMP
IGMPI
Certificate in Quality Management System for Medical

Devices (ISO 13485)
As a prevalent leader in professional training, we offer outstanding training and

professional guidance in Quality Management System (Medical Devices) which aids you to
excel in your field and meet up with your exact requirement. The training programmes of
IGMPI do not only focus on the theory but also give you the insight of real world. The
coverage of course also includes the present day scenario of suppliers’ control and detail
outlook to be considered in the: “Own Branding” and “Own labeling”. The students will also
gain benefits from training by getting knowledge about the risk management
system associated with outsourcing and supplier control.
This training is specially framed for providing the students with important
qualities for performing internal audits on a company’s Quality management systems
for Medical devices for the requirements of ISO 13485:2016 and to be responsible
for overall development. This also covers the process of gaining CE marking certification
under directive 93/42/EEC for all the medical devices which include: total joint implants
2005/50/EC and drug device combinations and associated directives 2003/32/EC. The
certification programme also includes the review of technical document and site audits.
The site audits will majorly analyze compliance with both ISO 13485:2003 and directive
93/42/EEC. This training course has been designed to indicate all the changes in regulatory
front so that the manufacturer of the medical device can better understand the
intricacies of updated EU IVDR and covers in vitro diagnostic medical devices and the
requirement mentioned in it are for the manufacturers, Notified bodies and member
state component authorities.
This training is going to assist your organization at compliance engineer,

quality professional, training auditor and general levels. It helps in understanding of how
the new regulatory norms are going to affect business, In addition is also guides
consultant and the customer to write and revise the quality documents and consolidate
technical files and provide guidance on quality and regulatory department. This course is
going to guide you to head out for intricacies while making sure that the compliance with
required regulations are met with top level of safety to patients and healthcare professional.
IGMPI
The beneficial output of this programme includes:

1) In depth knowledge of effectiveness of Quality Management System.
2) Overview of new regulations.
3) Practical application of USA, European Union and Indian medical device regulations.
4) Requirement of USA, European Union and Indian CE marking of medical devices
5) Requirement of USA, European Union and Indian marking of in vitro diagnostic medical
devices
6) Technical documentation for Medical Device compliance in USA, European Union and
India
7) Understand the requirement of ISO 13485:2016 -quality system requirement
8) Understand how to conduct internal audits
9) Detailed knowledge of ISO 13485:2016 audit and certification process
10)Develop knowledge and skills to prepare for third party audits against the requirement of
ISO 13485:2016
11)Better understanding of internal audits, audits of supplier and third party audits of
medical devices manufacturers.
Future career prospects of Certificate in Quality

Management System (Medical Devices)
Certificate in medical device will provide a horizon of knowledge to support you
and your organization in the path of success. It will help you understand every
step of assessment and procedures so that you fully understand the subject and
standards that are applied across the whole supply chain and seeks to address he entire life
cycle of Medical device.
IGMPI
Certificate in European Union (EU)

Medical Devices Regulation
The Medical Devices Regulation is the legislation detailing the requirements that manufacturers
have to meet to place medical devices on the market in the European Union. This course provides
essential knowledge to understand Regulatory Affairs of medical devices in EU and also conveys
key concepts of the European Medical Devices Regulation. This course focuses on device safety
and performance, emphasizing pre-market requirements, conformity assessment, quality
management aspects, Post Market Surveillance (PMS), transparency and traceability.

Module 1 : Medical Devices, In –vitro devices, Biologics & Combination Products:
Introductory Module
Module 2 : European Union Regulatory Guidelines on Medical Devices (Part 1)
Module 4 : Medical Device Registration, e-Submissions and Approvals in European Union

Medical Devices Industry is highly alluring sector now a days. Hence, there is fierce competition in
this sector. Proper training and knowledge in this field is required so as to reach the pinnacle of
success in particular sector. The objective of this course is to impart knowledge and understanding
about the medical device regulation legislation procedures that are available and the structure of
the registration dossier of medical devices in European Union. Professionals who are willing to
have a successful career in medical device industry should attend this course.
IGMPI
Certificate in In Vitro Diagnostic Medical Device

Directive – CE Marking for Europe (98/79/EC)
In Vitro Diagnostic (IVD) manufacturers that need to market their devices in Europe need a
strategy to successfully navigate through the certification process framed by the 98/79/EC
directive governing in vitro diagnostic medical devices. Similar to the Medical Device Directive
(MDD), the IVD Directive (IVDD 98/79/EC), includes requirements that govern the device's
performance and manufacturing, market placement and demands on safety and quality.
This certificate programme is designed for professionals in full time employment or those who
have prior industry experience who want to update their knowledge and gain required skills and
attitude in the area in order to become a certified professional in the domain.

Introductory Module
Module 4 : EU Directive 98/79/EC
Module 5 : Conformity Assessment Procedures

IGMPI
Certificate in Medical Devices Directive,

CE Marking for Europe (93/42/EEC)
CE marking is the medical device manufacturer’s claim that a product meets the essential
requirements of all relevant European Medical Device Directives. The Directives outline the safety
and performance requirements for medical devices in the European Union (EU). The CE mark is a
legal requirement to place a device on the market in the EU.

Introductory Module
Module 4 : Requirements for Technical Documentation: EU Directive 93/42/EEC

IGMPI
Certificate in Technical Documentation (93/42/EEC)

The Technical Documentation of the medical device consists of a set of documents drafted under
the responsibility of the manufacturer, notwithstanding the partial or total outsourcing of
resources at the design or production stage, to demonstrate the conformity of the medical device
to the requirements of EU Directive 93/42/EEC.

Introductory Module
Module 4 : Requirements for Technical Documentation: EU Directive 93/42/EEC

IGMPI
Certificate in EU IVD Medical Device Regulation

IVD devices (In Vitro Diagnostics) are a subset of medical devices primarily used for to testing
human fluids such as blood, tissue or urine in a test tube. This may include reagents, instruments
and specimen receptacles. In Europe, the In-Vitro Diagnostic Devices Directive (98/79/EC) is used
to regulate IVDs. In Vitro Diagnostic (IVD) manufacturers that need to market their devices in
Europe need a strategy to successfully navigate through the certification process framed by the
98/79/EC directive governing in vitro diagnostic medical devices. Similar to the Medical Device
Directive (MDD), the IVD Directive (IVDD 98/79/EC), includes requirements that govern the
device's performance and manufacturing, market placement and demands on safety and quality.

Introductory Module
Module 4 : EU Directive 98/79/EC

IGMPI
Eligibility
All those working in the Pharmaceutical Industry or any sector of Healthcare industry or any other
industry type (India or abroad) can apply for this short term programme. Life Science Graduate/
diploma holders are eligible for the course. Working professionals of any of the following industry
types; Drugs manufacturing , Medical Device, Ayurveda, Pharmaceutical Industry Regulation, Clinical
Research, Homeopathic or Ayurveda Medicine Manufacturing, Cosmetic Manufacturing, Food
manufacturing, Food Ingredient and Additive processing, Biotechnology or any related industry are
highly encouraged to apply for the programme.
*For Natural Health the applicant must be Graduate in MBBS/ BHMS/ BAMS/ BUMS/ Bpharm/
Mpharm/B.Sc. or M.Sc. in Nutrition & Dietetics and other related disciplines.
Programme Duration
The candidate is expected to complete the programme in 3 months.
Programme Deliverables
A comprehensive study material for all the modules in hard copies ensuring the needs of the audience.
The accompanying training material is appropriately aligned with the current Industry’s expectations.
Assignments for all the programme modules for continuous evaluation and guidance.
Interactive or recorded lectures on all key areas of the programme giving all flexibility to the
participants.
Assessment and evaluation for all the programme modules in order to enhance the levels of
competencies and skills of the participants leading towards the objective of application in the job. .
At the end of each programme modules, the trainers shall obtain feedback from the participants using
specially designed questionnaires.
All learning and training delivery initiatives shall be conducted in English.
Registration
The registration dates for this programme run by the institute are updated timely on the webpage.
Effective E-learning tools incorporated into the design of the webpage make the course lectures,
videos and study material easily accessible. This gives huge window of self regulated and self-paced
performance to the participants.
Examination & Certification

IGMPI follows a credit system based on all all learning activities involved in studying for all PG Diploma,
Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To
successfully complete the programme, you will have to earn all the credits assigned to your
programme.
IGMPI
All the participants are expected to appear for online exam and are also obliged to submit
assignments. After successful completion the participants will be awarded Certificate in GMP for
Finished Pharmaceuticals & Good Manufacturing Practices In Manufacturing, Processing, Packing or
Holding of Drugs / GMP In Manufacturing, Packing or Holding of Human Food / Food and Drug
Regulatory Agencies/ Process Analytical Technology / Documentation in QA & QC Department /
Registration of Drug and Dossier Preparation (CTD and eCTD submissions)/ Drug Registration
(European market) / Drug Registration (GCC Countries) / Drug Registration (African countries) / Drug
Registration (India)/ Drug Registration (US Market-ANDA,NDA etc.) / Preparation and submission of
drug master file (DMF), Prescription to OTC switch, Computer System Validation, Pharmaceutical
Validation, Computer Aided Drug Design (CADD), Good Clinical Practices (GCP), Analytical Testing and
Equipment, Basics of Sterile Manufacturing, Natural Health, Quality by Design, Chemical Safety and
HVAC Systems Validation and WHO-GMP. For all the above mentioned modules elaborate course
material, assignment and case studies would be provided by the Institute from time to time. Details
get updated on the webpage as well.
Corporate Relations
In recent months the Institute has witnessed more and more participation from professionals working
with global pharmaceutical, healthcare and food giants like Dr. Reddy's Laboratories, Aurobindo
Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, Ipca
Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent,
PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical,
Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc.
The IGMPI's Corporate Resource Division actively recommends our students and training participants
for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as
the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.
R
INSTITUTE OF GOOD MANUFACTURING PRACTICES INDIA
IGMPI Global accredited training & certification provider
Certificate Programme in : ........................................................................................................................................
PLEASE NOTE:
1. Please complete all the information accurately. Incomplete or false information may make your candidature null and void.
2. Fill the form in CAPITAL LETTERS only.
3. The decision of the Institute will be final and binding on the applicants in all the matters relating to registration.
4. For details of Program, please visit http://www.igmpiindia.org/ .
5. You are required to enclose self-attested photocopies of all relevant testimonials along with the registration form.The completed registration form
should be sent by a registered post or couriered to the Director, IGMPI, H-119, H Block, Sector-63, Noida-201 307, Delhi National Capital Region
(NCR), India, Phone: +91 8130924488, +91 8587838177, +91 120-4375280
6. You can send your signed application form and educational documents as scanned copies along with details of the online transaction to the email ID
(info@igmpiindia.org ), in case of fee payment through net banking or through wire transfer.
APPLICATION FEE DETAILS* Registration Number

AMOUNT Rs.
NEFT/PayU Ref. No. (Leave this space blank)
Affix a recent
DEMAND DRAFT/CHQ NO. coloured passport
DATED size photograph
BANK
*Crossed DD or cheque should be in favour of “Institute of Good Manufacturing Practices India”

payable at New Delhi. Please write your name and address at the back of DD/Cheque. Applicable
examination fee can be paid later as per the Institute's examination notification.
PERSONAL DATA
1. Name
(First Name) (Middle Names)(Last Name)
2. Gender Male Female
3. Date of Birth
DD MM YYYY
4. Age : Years _____ Months_____
5. (a) Address for correspondence (in capital letters)

Postal code/Zip code
(b) Permanent Address (in capital letters)
Postal code/Zip code

6. E-mail id :
7. Contact Telephone No. with STD Code Phone No. Mobile No.
IGMPI
8. Nationality_________________________
Ex- Defence
SC ST PH EWS Service
men
GEN OBC Personal
9. Category (SC: Scheduled Caste; ST: Scheduled Tribe; OBC: Other Backward Classes
PH: Physically Handicapped; EWS: Economically Weaker Sections; Ex-servicemen;
Defence Personnel; Attach copy of SC/ST/OBC, PH, EWS, Ex-servicemen,
Defence Personnel certificate as applicable for 10% fee concession)
WORK EXPERIENCE
10. Work Experience (if any)

i) Total Work Experience ____years ____months and ____days
ii) List all your work
Total Name
From To Completed the Designation Brief Job Profile
Months Organization
Days
ACADEMIC QUALIFICATIONS
11. Pre-Bachelor's Degree Examination(s):
Total
% Marks Class/
Std. School / Institution Board/ University Year completed Max. Marks Division
Marks Obtained Obtained
10th/
High School
th
12 /
Intermediate/
Senior Secondary
IGMPI
12. Bachelor's Degree Examination(s):
Degree Obtained Subject /

Specialization
College/Institute University
Year Date Marks considered for award of Class/Division in Bachelor's Degree
From (DD/MM/YYYY) To (DD/MM/YYYY) CGPA/ % Marks Obtained/ Grade
13. Post-Graduation Degree/Diploma (if any):

Specialization
Year
Max. Marks % of Marks
From To Subject Marks Obtained Obtained
(DD/MM/YYYY) (DD/MM/YYYY)
Overall percentage of marks obtained
14. Professional qualification (if any):

Specialization
Year
Max. Marks % of Marks
From To Subject Marks Obtained Obtained
(DD/MM/YYYY) (DD/MM/YYYY)
Overall percentage of marks obtained
DECLARATION
I have carefully filled up all the information and agree to abide by the decision of the Institute of Good Manufacturing Practices India,
New Delhi authorities regarding my registration. I certify that the particulars given by me in this form are true to the best of my knowledge and belief.
Place
Date Signature of Applicant
IGMPI
Delhi NCR
IGMPI, H-119, H Block, Sector-63, Noida-201 307, Delhi National Capital Region (NCR), India
Phone: +91 8130924488, +91 8587838177, +91 120-4375280, +91 120-2427175
E mail: info@igmpiindia.org

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Institute of Good Manufacturing Practices India R

Trusted by organizations & training participants in over 30 countries

(3 Months Advanced Programme)

Accreditation and Awards

Quality Council of India (QCI)

National Skill Development Corporation (NSDC)

ADVISORY BOARD AND TEAM

ADVISORY FACULTY FROM INDUSTRY

IGMPI Certified Modules

Future career prospects of the programme

GMP in Manufacturing, Packing or Holding of Human Food

IGMPI Certified Modules

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Food and Drug Regulatory Agencies

IGMPI Certified Modules

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Process Analytical Technology

IGMPI Certified Modules

Future career prospects of the programme

Documentation in QA & QC Department

IGMPI Certified Modules

Future career prospects of the programme

Registration of Drug and Dossier Preparation (CTD and e CTD

IGMPI Certified Modules

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Drug Registration (European Market)

IGMPI Certified Modules

Future career prospects of the programme

Drug Registration (GCC countries)

IGMPI Certified Modules

Future career prospects of the programme

Drug Registration (African countries)

IGMPI Certified Modules

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Drug Registration (India)

IGMPI Certified Modules

Future career prospects of the programme

Drug Registration (US Market-ANDA, NDA etc)

IGMPI Certified Modules

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Preparation and Submission of Drug Master File (DMF)

IGMPI Certified Modules

Future career prospects of the programme

Prescription to OTC switch

IGMPI Certified Modules

Future career prospects of the programme

Computer System Validation

IGMPI Certified Modules

Future career prospects of the programme

IGMPI Certified Modules

Future career prospects of the programme

Computer Aided Drug Design (CADD)

IGMPI Certified Modules

Future career prospects of the programme

Good Clinical Practices (GCP)

IGMPI Certified Modules

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Analytical Testing and Equipment

IGMPI Certified Modules

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Certificate in Sterile Manufacturing

IGMPI Certified Modules

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Certificate in Naturopathic Science

4. Age : Years _ Months_