25th-26th October 2018

AGENDA

DAY ONE – 25th October 2018

08:30 - 09:00 Registration and networking

09:00 - 09:15 Opening remarks by UBM

GMP update – current regulatory trends and changes during the last decade
for US FDA, EU, WHO and PICS
09:15 - 10:15
 Differences between EU and FDA GMP
 Challenges in implementing right GMP processes
10:15 - 10:30 Q&A

10:30 - 11:00 Morning refreshments

Understanding the Pharmaceutical Quality Systems ( PQS ) model
 Effective use of quality risk management principles ICH Q8 and ICH
11:00 - 11:30  Q9)
 PQS Elements in ICH Q10
 21 CFR 210 & 211 Components of the Quality System
Q&A
11:30 –11:45
What is risk based approach to GMP – understanding quality risk
management
11:45 –12:15
 ICH Q9 in the context of ICH Q8 and ICH Q10
 Designing an effective risk management application
12:15 - 12:30 Q&A

12:30 –13:00 Partner Presentation (To be decided)

13:00 -14:00 Lunches and Networking

Qualification and validation – a practical and sensible approach
 Case study : warning letters received due to wrong validation reports
14:00 –15:30
 Implementing installation qualification (IQ) & performance
qualification (PQ) techniques to ensure compliance
15:00-15:15 Q&A
The mechanics of operation of deviation and change management – from
clarity to continuum
15:15 - 16:30
 Deviation handling: Importance of documenting
 Reviewing human errors effectively
  Introduction to change control management

16:30 –16:45 Q&A

Good documentation - principles and practices to meet the requirements of
US FDA, MHRA, WHO & PICS guidelines
16:45 –17:15
 Inadequate document management and GMP non-compliant
analytical software
17:15 – 17:30 Q&A

17:30 Closing remarks

End of workshop day one

DAY TWO - 26th October 2018

08:00 – 09:00 Registration and networking

Panel Discussion:
Discussing the future of Pharmaceutical manufacturing in India considering the
changing regulations

09:00 - 09:45  Capitalising on export opportunities

 Artificial Intelligence: Present and Future
 Importance of monitoring risks in real time at plants
 Continuous manufacturing

Understanding Advanced Quality systems management for the regulatory

market today
09:45 - 10:30
 Designing a Quality Management System
 Difference of EU/ US guidelines for QSM
10:30 - 10:40 Q&A

10:40 - 11:10 Morning refreshments

Adopting modern analytical development
11:10 – 12:10  The growth of auto injectors in the pharmaceutical industry
 Principles of Analytical Procedure Lifecycle Management (APLM)
Q&A
11:30 – 11:45
Investigations and CAPA
11:45 – 12:15  Ways of avoiding FDA 483 observations through effective investigation and
CAPA procedures
12:15 - 12:30 Q&A
ICH M11: Clinical electronic Structured Harmonised Protocol (CeSHarP) &
12:30 – 13:00 Continuous manufacturing (Q13);
 Understanding the new regulations under ICH guidelines
13:00 -14:00 Lunches and Networking
GMP and beyond with understanding importance of Process validation,
equipment qualifications, stability testing
14:00 – 15:30
 Ensuring effective cleaning validation practices and procedures
 Selecting an experienced stability study to meet regulatory
 requirements

15:30-15:40 Q&A
Quality Auditing Practices
15:40 - 16:40  FDA’s final guidance for Handling Amendments to submissions for
pharmaceutical products
16:40 – 16:50 Q&A
DI - ALCOA principles, ALCOA plus
16:50 – 17:30  Insufficient handling of DI and validation of analytical methods
 Data integrity: Best Practices for using eHRs in Clinical investigation
17:30 – 17:40 Q&A

17:40- 17:45 Closing remarks

End of workshop