SPEAKERS:

Dr Bettina Pahlen
Quality x Pharma Consulting
Dr Heinrich Prinz
Apceth
Dr Wolfgang Schumacher
F. Hoffmann-La Roche
LEARNING OBJECTIVES:
GMP: Where do we come from
where do we go?
Basic principles of GMP
Personnel
Hygiene
Premises / Production
Documentation
Risk management
Qualication / Validation
Communication with clients/
authorities
Elements of a QA System
Change Control
Deviations
CAPA (Corrective Actions
Preventive Actions)
Failure Investigations
OOS (Out of Specication)
Audits Inspections
Measurements against falsied
products
30 - 31 October 2014, Berlin, Germany
GMP for Beginners
Understanding the importance of GMP
This education course is recognised for the ECA GMP Certication Programme Certied QA Manager. Please nd details at www.gmp-certication.eu
Commisson directive 2003/94/EC
The personnel shall receive initial and ongoing training,
the effectiveness of which shall be veried, covering in par-
ticular the theory and application of the concept of quality
assurance and good manufacturing practice .
EudraLex Vol. 4 Good manufacturing practice (GMP) guide-
lines
2.9 Besides the basic training on the theory and practice of
Good Manufacturing Practice, newly recruited personnel
should receive training appropriate to the duties assigned to
them..
Objectives
The course is designed for people who have no or little
knowledge of GMP:
You get to know the most important pharmaceutical
regulations and their importance,
you get a basic overview of GMP requirements in
pharmaceutical production and
you become familiar with technical terms from the
eld of GMP and their meaning

Background
In the manufacture and quality control of medicinal prod-
ucts, compliance with the GMP rules is the decisive aspect
for manufacturing high-quality products. For this reason,
every staff member in the pharmaceutical industry has to
be familiar with the basic GMP requirements. The relevant
European GMP regulations dene the following prerequi-
sites:
In practice, many members of staff are often unaware of
the contents and meaning of the different GMP require-
ments from Europe and the US and their consequences
for product quality. During this course, speakers with long-
standing experience in the training of employees intro-
duce and explain the most important elements of a phar-
maceutical GMP system in an easy-to-understand way.
Target Group
The course is directed to staff from the pharmaceutical in-
dustry having no or little experience with the current GMP
requirements. This includes both employees who, after
their vocational training, enter the pharmaceutical indus-
try and experienced colleagues who work for the rst time
in a GMP-regulated environment. Participation is also rec-
ommended for personnel from suppliers who have to un-
derstand the quality requirements of their customers.
Programme
GMP: where do we come from - where do we go to?
Development of GMPs
GMP: Goal and general ideas
Types of regulatory documents and their meaning
GMP regulation for APIs, medicinal products and
excipients - a comparison
Authorities and industry groups: ICH, PIC/S, EMA,
FDA, WHO, APIC, ISPE, IPEC
GMP in the US
Comparison of US and EU regulations
Differences between European and FDA view on
GMP / GMP vs cGMP
Typical expectations of FDA and European inspectors
Quality Management System
Quality Management System cited in the regulations
General aspects of Quality Assurance
How to implement and structure a system
Responsibilities
Personnel and Training
General aspects
Qualication
Key personnel
Job descriptions
Training (purpose, goals, contents, target groups)
Planning and documentation of training
Hygiene / Personal Hygiene
General aspects and rules
Hygiene programme
Personnel ow
Medical examination
Contamination
Monitoring
Documentation
Structure of documentation
Responsibilities for the documentation
SOP
Documentation in the manufacturing process
Documentation in the quality control
Batch record review
Annual report / Product quality report
Specications
Specic Aspects of a QA System
Deviations
CAPA
Change Control
OOS
Failure Investigations
Self-inspections
GMP for Beginners
30-31 October 2014, Berlin, Germany
Risk Management
Main topics of ICH Q 9 / Annex 20
Risk management tools
Use of risk analysis during qualication
How to handle FMEA?
Premises / Production
Requirements for room and equipment
Classication of rooms
Sterile production/isolator
Maintenance of hygiene
How to behave during production
Qualication/Calibration/Maintenance
Denitions: Qualication, validation, calibration,
maintenance, risk analysis
Organizing qualication and validation: the validation
master plan (VMP)
Steps in qualication studies: DQ, IQ, OQ, PQ
Qualication parameters of typical types of
equipment: Clean rooms, water systems, production
equipment, analytical equipment
Performing risk analysis: tools and practical tips
Calibration: critical types of equipment
How to build up a calibration system
Maintenance: Requirements and system
Validation of computerised systems
Process Validation and Validation of Analytical Methods
General aspects and requirements
Process validation
Documentation of process validation
Validation of analytical methods
Documentation of analytical methods validation
Cleaning Validation
Regulators requirements
The cleaning procedure
Building up a cleaning validation
Sampling
Analytical tests
Audits and Inspections
Types of audits
Requirements
Dos and donts for the auditee - How to survive audits?
Performing audits and self-inspections
Good audit practices
Packaging/Storage/Transportation
Packaging/Storage/Transportation in the regulations
Managing of packaging process
What is necessary to regulate in a pharmaceutical
company
WHO good storage practice elements and
requirements
Transportation as part of storage
How to maintain the quality during transportation
Measurements against falsied Products
Regulatory requirements
Responsibilities of QP and the pharmaceutical
industry
What measurements can be taken
Strategies against falsied products
Speakers
Dr Bettina Pahlen, Quality x Pharma Consult-
ing GmbH, Alling, Germany
Bettina Pahlen, PhD, studied pharmacy at the
University of Muenster, Germany, graduated
in pharmaceutical chemistry and performed
post-docs in USA and Germany. During the
last 15 years she worked at university, authority and in
different areas of the pharmaceutical industry (R&D,
manufacturing, quality control, quality assurance). Since
July 2007, she has been working as a consultant in the
pharmaceutical industry focussing on GxP Quality Assur-
ance aspects.
Dr Heinrich Prinz, Apceth, Germany
Dr Prinz worked with Boehringer Mannheim
before he joined Biotest where he was Head
of Quality Assurance, responsible for both
the pharmaceutical and the medical device
division. Since 2003 he works as a freelance
consultant and part of his time he is the Senior Supervi-
sor Production and Quality Assurance at Apceth, a bio-
tech company.
Dr Wolfgang Schumacher, F. Hoffmann-
La Roche Ltd., Switzerland
Dr Schumacher studied chemistry and phar-
macy. After entering Asta Medica, he headed
different positions. In 2001 he joined F. Hoff-
mann-La Roche, Basle, where he is now Head
of the department of Quality Computer Systems. He is a
member of the ECA Advisory Board

Social Event
In the evening of the rst course day, you are cordially
invited to a social event. This is an excellent opportunity
to share your experiences with colleagues from other
companies in a relaxed atmosphere.
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Easy Registration

Reservation Form:
CONCEPT HEIDELBERG
P.O. Box 10 17 64
69007 Heidelberg
Germany

Reservation Form:
+ 49 6221 84 44 34
@
e-mail:
info@concept-heidelberg.de

Internet:
www.gmp-compliance.org
#
Date
Thursday, 30 October 2014, 09.00 h 18.00 h
(Registration and coffee 08.30 h 09.00 h)
Friday, 31 October 2014, 08.30 h 17.00 h
Venue
Steigenberger Hotel Berlin
Los-Angeles-Platz 1
10789 Berlin, Germany
Phone +49(0)30 2127 0
Fax +49(0)30 2127 117
Fees (per delegate plus VAT)
ECA Members 1,290
APIC Members 1,390
Non-ECA Members 1,490
EU GMP Inspectorates 745
The conference fee is payable in advance after
receipt of invoice and includes conference docu-
mentation, dinner on the rst day, lunch on both
days and all refreshments. VAT is reclaimable.
Accommodation
CONCEPT HEIDELBERG has reserved a limited
number of rooms in the conference hotels. You
will receive a room reservation form when you
have registered for the event. Reservation should
be made directly with the
hotel. Early reservation is recommended.
Registration
Via the attached reservation form, by e-mail or by
fax message. Or you register online at
www.gmp-compliance.org.
Conference Language
The ofcial conference language will be English.
Organisation and Contact
CONCEPT HEIDELBERG
P.O. Box 10 17 64
69007 Heidelberg, Germany,
Phone +49(0)62 21/84 44-0
Fax +49(0)62 21/84 44 84
info@concept-heidelberg.de
www.concept-heidelberg.de
For questions regarding content:
Dr Andreas Mangel (Operations Director)
at +49(0)62 21 / 84 44 41 or per e-mail at
mangel@concept-heidelberg.de.
For questions regarding reservation, hotel,
organisation etc.:
Ms Marion Weidemaier (Organisation Manager)
at +49(0)62 21 / 84 44 46 or per e-mail at
weidemaier@concept-heidelberg.de.
wa/vers2/18062014