Industrial Pharmacy

Processes and Requirements in the

Pharmaceutical Industry

11-12 December 2013, Heidelberg, Germany

SPEAKERS: PROGRAMME:
Dr Jean-Denis Mallet „„ Principles of the Pharmaceutical
ECA & Former Head of Pharmaceutical Industry
Inspection Dpt, Afssaps „„ Quality Systems and Regulatory
Affairs
Dr Josef Hofer
„„ The starting point of GMP:
EXDRA
„„ Chemical & biotechnological API
Dr Afshin Hosseiny synthesis
Tabriz Consulting Limited „„ Dosage forms and action of drugs
Dr Harald Stahl „„ Manufacture of solid dosage forms
GEA Pharma Systems „„ Manufacture of semi-solid dosage
forms

„„ Manufacture of sterile drugs
„„ Packaging of medicinal products

This education course is recognised for the ECA GMP Certification Programme „Certified Technical Operations Manager“. Please find details at www.gmp-certification.eu
Industrial Pharmacy
11-12 December 2013, Heidelberg, Germany

Objectives Programme

This education course aims at clearly explaining the in-
terrelationship in pharmaceutical production – from au-
thorisation to drug production and release. It will focus
on illustrating the various production processes and
their demands on equipment and facilities from devel-
opment to routine production. Requirements from the
QA perspective as well as the way the different dosage
forms work will complete the seminar.
The Pharmaceutical Industry
„„ Development of drug
„„ Finding the right galenical form
„„ Clinical trials - from phase I to III
„„ From launch to routine production
„„ Batch to batch vs. continuous processing
„„ End of patent and Generics
Dr Afshin Hosseiny

Background Important QA Systems in the Pharmaceutical

Environment
In addition to staff in the pharmaceutical industry there „„ CAPA, Change Control, …
are many service providers and suppliers connected with „„ Validation and Qualification
the industry. They also have to deal with their customers’ „„ GMP Audits and Inspections
requirements – from the view of regulations as well as „„ Responsibilities and functions (QP, Head of ..)
from processes. However, how many are pharmacists or „„ Batch documentation and release, QA & QC
know the different pharmaceutical processing steps? „„ Supplier Qualification
Dr Afshin Hosseiny
Even within pharmaceutical companies the high speciali-
sation makes it difficult to take a look beyond the own Regulatory Affairs
area. An understanding for the interrelationships in the „„ GMP compliance vs. regulatory compliance
production of medicinal products facilitates communi- „„ Submissions/Applications in EU and US
cation and increases efficiency of your own work. We „„ Required data for submissions
would like to pose important questions and provide the –– Quality (main part)
answers for: –– Efficacy
–– Safety
„„ Where does GMP start? „„ Changes and variations in EU and US
„„ How does the pharmaceutical quality management „„ Influence of registration documents on daily business
system work? Dr Josef Hofer
„„ What is stated in the authorisation and how does this
affect production? Dosage Forms & Actions of Drugs
„„ How are tablets and other dosage forms produced? „„ Different dosage forms and their applications
„„ What are the critical process parameters and the criti- „„ Resorption, distribution, biotransformation
cal equipment components? „„ Kinetics and mechanism of action
„„ How do the various dosage forms work? „„ Therapeutic index & Adverse effects
„„ Who is responsible for what and who decides? „„ Influence of finished dosage parameters on action
of drugs
Dr Josef Hofer
Target Audience
Chemical and biological API Production
This course addresses Non-Pharmacists working for or „„ Difference between API and final dosage form
with pharmaceutical companies, as well as staff within production
the pharmaceutical industry working in areas adjacent to „„ Where does GMP start?
production and pharmacists, new in the pharmaceutical „„ Fundamentals of API production: From raw material to
industry: the final intermediate and the API
„„ Staff in engineering, sales, logistics, business develop- „„ Fundamentals of biotechnological API production:
ment etc. microorganisms as mini plants
„„ Consultants and service providers Dr Afshin Hosseiny
„„ Prospective heads of production and quality assu-
rance without pharmaceutical background Semi-Solid Dosage Forms
„„ Basics of oil/water mixtures
„„ Importance of raw materials
„„ Clean Room an equipment requirements
„„ Clean room concepts: Class C, D, E, ….
„„ Production process
„„ Filling of non-sterile liquid and semi-solid forms
Dr Jean-Denis Mallet
Fundamentals of Solida Production Speakers
„„ Fundamentals of
–– Granulation Dr Josef M. Hofer
–– Spray Drying Exdra GmbH, Germany
–– Compaction Dr Josef Hofer is Managing Director of
„„ Critical Process Parameters (CPQs) exdra GmbH (excellence in drug regulatory
„„ Equipment requirements affairs.). Since1999, Dr Hofer is assistant lec-
Dr Harald Stahl turer at the University in Bonn (Germany)
for Regulatory Affairs.
Sterile Manufacturing Operations
„„ Prerequisites for aseptic processing Dr Afshin Hosseiny
„„ Requirements for equipment and premises Tabriz Consulting Limited, Great Britain
„„ Clean room concepts: Class A, B, C, D Dr Afshin Hosseiny is Managing Director of
„„ Typical material and personal flows Tabriz Consulting Ltd. Before working as a
„„ Media fill consultant, he was Director of Quality As-
„„ Filling of vials, ampoules and prefilled syringes surance for the Global Supply Network of
„„ 100% inspection GlaxoSmithKline
Dr Jean-Denis Mallet
Dr Jean-Denis Mallet
Primary and Secondary Packaging ECA, former head of the French Inspection
„„ Primary packing Department, SNC LAVALIN, France
„„ Secondary packaging Jean-Denis Mallet is a pharmacist. He was
„„ Room classification for primary and secondary previously the Head of the Pharmaceutical
packaging and Cosmetics Inspection Department at
„„ Specific requirements in the pharmaceutical the French Health Products Regulatory
packaging process Agency (Afssaps). He also used to work in or with the
„„ Packaging as the main reason for recalls pharmaceutical industry during many years at various po-
Dr Afshin Hosseiny sitions including Quality Assurance, Production Manage-
ment, Engineering and GMP Consulting. He has also been
auditor of the International Red Cross Now he is member
of the ECA advisory board and works for SNC LAVALIN.
Social Event
Dr Harald Stahl
On 11 December you are cordially invited to a social GEA Pharma Systems, Germany
event. This is an excellent opportunity to share your ex- Dr Harald Stahl worked for 3 years in the
periences with colleagues from other companies in a re- Pharmaceutical Development of Schering
laxed atmosphere. AG in Germany. At that time his main inter-
est was the aseptic production of pellets.
Since 1995 he served within GEA Process
Technology in various positions. Presently he owns the po-
sition of a Senior Pharmaceutical Technologist of GEA
Pharma Systems. He has published more than 20 papers
on various aspects of pharmaceutical production.

Heidelberg – Optimal Accessibility via Frankfurt:

Airport Shuttle Service: PCS & HLS
Phone: +49 (0)6221 – 164 664 / Fax +49 (0)6221 – 183 094
pcs@pcs-hd.de / www.pcs-hd.de
approx. 70 € one way (as of January 2012)
Lufthansa Airport Shuttle: Booking and fares: Phone +49
(0)6152 – 97690-99, Fax +49 (0)6152 – 97690-21, info@frank-
furt-airport-shuttles.de, http://www.transcontinental-group.
com/en/frankfurt-airport-shuttles
Train: You can get on the train directly at the Airport. Trains
leave up to two times per hour and it takes less than an hour to
get to Heidelberg (cost: approx. 25€). http://www.bahn.de

Fly to Frankfurt and stay in Heidelberg - one of the

most beautiful cities in Europe
 Easy Registration
 Reservation Form:
CONCEPT HEIDELBERG  Reservation Form:
+ 49 6221 84 44 34 @ e-mail:
info@concept-heidelberg.de  www.gmp-compliance.org
Internet:

P.O. Box 10 17 64
69007 Heidelberg
Germany

full registration fee, even if you have not made the payment yet. Only after we have received
fee will then be calculated according to the point of time at which we receive your message.

your payment, you are entitled to participate in the conference (receipt of payment will not
In case you do not appear at the event without having informed us, you will have to pay the
Date

Wednesday, 11 December 2013, 09.00 h to approx. 18.00 h

(Registration and coffee 08.30 h – 09.00 h)
Thursday, 12 December 2013, 08.30 h to approx. 15.15 h
Purchase Order No, if applicable
Venue

Country
Crowne Plaza Hotel Heidelberg
Kurfürstenanlage 1
69115 Heidelberg, Germany
Phone +49(0)6221 917 0
Fax +49(0)6221 210 07
E-Mail (please fill in)
Fees

ECA Members € 1,490.- per delegate plus VAT

Zip Code

APIC Members € 1,590.- per delegate plus VAT

be confirmed)!
(does not include ECA Membership)
Non-ECA Members € 1,690.- per delegate plus VAT
EU GMP Inspectorates € 845.- per delegate plus VAT
The conference fee is payable in advance after receipt of
invoice and includes conference documentation, dinner
fied as soon as possible and will receive a full refund of fees paid. CONCEPT HEIDELBERG will
not be responsible for discount airfare penalties or other costs incurred due to a cancellation.

on the first day, lunch on both days and all refreshments.

without notice or to cancel an event. If the event must be cancelled, registrants will be noti-

non-appearance. If you cannot take part, you have to inform us in writing. The cancellation
Important: Please indicate your company’s VAT ID Number

CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers

Important: This is a binding registration and above fees are due in case of cancellation or

VAT is reclaimable.
11-12 December 2013, Heidelberg, Germany

Terms of payment: Payable without deductions within 10 days after receipt of invoice.
Reservation Form (Please complete in full)

Accommodation

CONCEPT HEIDELBERG has reserved a limited number of

rooms in the conference hotel. You will receive a room reser-
vation form when you have registered for the event. Please
use this form for your room reservation to receive the spe-
Company Department

cially negotiated rate for the duration of your stay. Reserva-

Ms.
Industrial Pharmacy

tion should be made directly with the hotel. Early reservation

Title, first name, surname

is recommended.
Street/P.O. Box

Registration
* Mr.

Phone/Fax

Via the attached reservation form, by e-mail or by fax mes-

City

sage. Or you register online at www.gmp-compliance.org.

Conference language

The official conference language will be English.

If the bill-to-address deviates from the specifications on the right,

Organisation and Contact

2. If you have to cancel entirely we must charge the following processing fees: Cancellation

CONCEPT HEIDELBERG
P.O. Box 10 17 64
D-69007 Heidelberg, Germany
Phone +49 (0) 62 21/84 44-0
Fax +49 (0) 62 21/84 44 34
E-mail: info@concept-heidelberg.de
www.concept-heidelberg.de
1. We are happy to welcome a substitute colleague at any time.
If you cannot attend the conference you have two options:
Fax +49 (0) 62 21/84 44 34

For questions regarding content:

CONCEPT HEIDELBERG

Dr Robert Eicher (Operations Director) at

D-69007 Heidelberg

+49-62 21 / 84 44 12, or per e-mail at

 within 1 week prior to the conference 100 %.
 until 2 weeks prior to the conference 10 %,
 until 1 weeks prior to the conference 50 %

eicher@concept-heidelberg.de.
P.O. Box 101764

For questions regarding reservation, hotel, organisation etc.:

GERMANY

General terms and conditions

Mr Ronny Strohwald (Organisation Manager)

please fill out here:

at +49-62 21 / 84 44 51, or per e-mail at

strohwald@concept-heidelberg.de.

wa/vers1/23012013