3-Day GMP Education Course

Photo: LEONHARD WEISS Fussbodentechnik GmbH & Co. KG

 Latest News about Annex 1

 Workshop URS / DQ

Clean Rooms

FDA- and GMP-compliant design, layout and operation

10 – 12 June 2008, Barcelona, Spain

SPEAKERS: LEARNING OBJECTIVES:

Danny Van Dyck, MBA  Regulatory Requirements and cGMP
Cilag AG, Switzerland Compliance
– Guidelines and Technical Standards
Dr Udo Gommel  Clean Room Design
Fraunhofer Institute IPA, Germany – Layout: Walls, Ceiling, & Floor
Dr Robert Johnson – Zone Concepts
 Engineering of Clean Rooms
Dialogue, Switzerland
 Implementation and Operations of
Thomas von Kahlden HVAC Systems
CCI - von Kahlden GmbH, Germany  Equipment Design for Clean Room Use
 Risk based Qualification and Validation
Dr Jean-Denis Mallet – Qualification according to ISO
Formerly Head of the French Pharmaceutical Standards and GMP Guides
Inspection Department, France – Microbial Validation
 Environmental Monitoring Techniques
Andreas Nuhn
 cGMP Compliant Clean Room
Carpus & Partner AG, Germany
Operation
Jolande Schoemaker – Data Interpretation and QA Actions
Schoemaker Consultancy, The Netherlands – Cleaning and Cleaning Validation

Andreas Wokittel
Lauterbach + Söhne GmbH, Germany
Clean Rooms
10 – 12 June 2008, Barcelona, Spain
Objectives
The course is designed to provide an understanding of
the current guidelines and regulatory requirements for
clean room design, operation and management. Prag-
matic, cost effective and scientifically sound advice on
compliance to the technical requirements in the project-
and design phase as well as in the manufacture of sterile
products will be provided.
 Theory
You will learn the latest regulatory requirements as well
as the requirements coming from the EN ISO standards
for design and operation of clean rooms.
 Design
GMP-compliant HVAC and equipment design, clean
room zones, choosing RABS or isolator and develop-
ment of a design specification (URS) are the main topics
of this part.
 Qualification/Validation
You will learn how to choose and correctly use measure-
ment technology as well as modern qualification of clean
rooms using the risk based approach.
 Routine Operation
A validated environmental monitoring, efficient cleaning
procedures as well as effective training of personnel are
the key factors for maintaining the validated state and
content of the last part of the course.
Background
In these days of globalisation and of production facilities
serving vast market areas, pharmaceutical clean rooms
are expected to demonstrate compliance with the provi-
sions of the European regulatory authorities and of the
FDA. They should do so convincingly and economically.
The EN ISO standards on clean room technology offer
themselves as the appropriate fundament for converting
the GMP guidances into technically sound contamina-
tion control concepts.
Target Group
This GMP course is designed for engineers, production
and QA staff, responsible for the design of clean rooms
as well as the GMP compliant operation and maintaining
the validated state.
Moderator
Dr Robert Johnson, Dialogue, Switzerland
Programme
Regulatory Guidelines and cGMP Compliance
 Current guidelines and Regulatory requirements
 EU GMP guide Annex 1
 FDA Guideline „Sterile drug products produced by
aseptic processing“
Dr Robert Johnson, Dialogue, Switzerland
Layout of Clean Rooms according to standards and
guidelines
In this lecture the guidelines for floors, walls and ceilings
are discussed. In the GMP-Guidelines some require-
ments for the layout of clean rooms are listed, but with-
out details how the installation should be. The relation
between the GMP-Guidelines and European standards is
made and practical solutions are presented.
 Survey of current standards
 Setting specifications for single rooms: the room book
 Introduction to HVAC and filters
 Clean Room walls, ceiling and floor
Thomas von Kahlden, CCI - von Kahlden GmbH, Germany
Clean Room and Zoning Concepts
 Objectives
 Zoning for aseptic and non aseptic productions
 Reasonable zoning concepts
 Different technical realisations
Andreas Nuhn, Carpus Prozess Experten GmbH,
Germany
Clean Rooms for a Clinical Pilot Plant – A case study
 Introduction: need and scope of a new facility
 Layout and design (including RABS vs. Isolators)
 Ready for a validatable automated decontamination
process for the clean rooms
 Project management - some points of attention
Danny Van Dyck, Cilag AG, Switzerland
Design criteria: Performance requirements for
Ventilation / Air-conditioning systems
 Normative references
 Classification of ventilating and air-conditioning
systems
 Components in ventilating and air-conditioning
systems
 Design criteria
 Design in consideration of hygiene quality
 Potential savings
 Different versions of ventilation systems in
„GMP – Areas“
 Frequent deficiencies during design and installation
Andreas Wokittel, Lauterbach + Söhne GmbH, Germany
Qualification of Clean Rooms according to ISO 14644
and the GMP-Guidelines
The presentation deals with the parameters which have
to be measured during qualification, requalification and
the monitoring of clean rooms. The correlation is made
between the procedures of the ISO Standards to the
specified parameters and limits of the GMP-Guidelines.
The most important measurement devices will be dis-
cussed. Examples of measurements and their documen-
tation are shown.
 Differential pressure
 Air speed, volume flow and visualisation
 Leak testing
 Recovery measurement
 Determination of the Clean Room class
Thomas von Kahlden, CCI - von Kahlden GmbH, Germany
Equipment Design for Clean Room Use
 Concept strategies for clean room equipment
 Air flow design (simulation and visualization)
 Avoiding contamination by usage of appropriate
materials
 Low-contamination patterns in regard of particle
generation
 Outgassing behavior & ESD-Properties
 Cleanability and bio contamination
 Validation and Qualification: Tests for proving clean
room appropriateness of equipment
Udo Gommel, Fraunhofer Institute – IPA, Germany
Inspections of Clean Rooms
 Introduction: continuous improvement of clean
rooms
 Focus during inspections of clean rooms
 Techniques used in inspections of clean rooms
 Typical failures in design, layout and operation
 Difference between major and minor findings
Dr Jean-Denis Mallet, Formerly Head of the French
Pharmaceutical Inspection Department, France
Workshop
User Requirements and Design Qualification
Apply all learning matter to develop a URS and subse-
quent perform a DQ for a complete facility - what is
must and what is nice to have, production process and
legal related requirements have to be combined.
A risk based approach to Qualification and Validation
 commissioning vs. qualification: procedure and
examples
 physical and microbiological parameters
 compiling a risk analysis
 important tests during qualification and validation
 avoidance of typical failures
Jolande Schoemaker, Schoemaker Consultancy,
The Netherlands
Environmental Monitoring
 Microbiology of clean rooms
 Monitoring techniques
 Designing an effective EM programme
 Setting alert and action levels
 Interpreting EM data
Dr Robert Johnson, Dialogue, Switzerland
Cleaning of Clean Rooms
 Selection of disinfectants
 Application of cleaning agents
 Validation of disinfection procedures
Jolande Schoemaker, Schoemaker Consultancy,
The Netherlands
Training of Personnel
 GMP and microbiology
 Qualification of clean room operators
 Good aseptic practice
 Cleanroom operator gowning
 Performance review
Dr Robert Johnson, Dialogue, Switzerland
Social Event
On Tuesday, 10 June, 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.
Speakers
Danny Van Dyck, MBA, Cilag AG - Switzerland
Mr. Van Dyck studied chemical and agricultural engineering
followed by environmental technology and holds an MBA. He
started his career at Janssen Pharmaceutica in 1992 and became
Pharmaceutical Manufacturing Supervisor 1994. In 2000 he
became Project Leader for Sterility Technology and Senior
Project Manager Engineering R&D for Cilag in 2005. Addition-
ally in 2006 he became Senior Manager Technical Services
Parenterals. Mr. Van Dyck was responsible for the project
realisation of a new state of the art R&D clinical trial production
unit from 2005 to 2007.
Dr Udo Gommel, Fraunhofer IPA – Germany
Udo Gommel studied Physics and works at the Fraunhofer
Institute for Manufacturing Engineering and Automation (IPA)
since 1996. In 2001 he founded the industrial alliance for
Cleanroom Suitable materials CSM. He is member or leader of
several guideline committees ((VDI, DIN, ISO) and became
Head of the Cleanroom Testcenter and Group Manager for
Contamination Control & Clean Production Technologies at the
Fraunhofer IPA in 2004. Since 2008 is Head of the Ultraclean
Technology and Micromanufacturing“ department of the
Fraunhofer IPA in Stuttgart.
Dr Robert Johnson, Dialogue – Switzerland
Robert Johnson is currently the CEO of Dialogue, a consul-
tancy operation providing a range of activities to support
pharmaceutical operations and training. Previous to his
current role he was head of Global Quality at PLIVA, Croatia.
Before joining PLIVA Robert held different senior positions at
GSK in the UK (e.g. Area Director, Global Quality and Senior
Global Quality Manager Microbiology). He has been
involved in multiple inspections from the MHRA, FDA, EMEA
and other authorities. Robert is a Registered Qualified Person
as well as Expert and Committee Member of British Pharma-
copoeia.

Thomas von Kahlden, CCI - von Kahlden GmbH – Germany

Thomas von Kahlden is managing associate of the CCI van
Kahlden GmbH. He studied engineering and worked at the
Fraunhofer Institute for Engineering and Automation
between 1984 and 1996. He is member of the VDI and ISO
boards for clean room technology for more than 10 years.

Dr Jean-Denis Mallet, Formerly Head of the French Pharma-

ceutical Inspection Department – France
Jean-Denis Mallet is a Doctor Pharmacist, graduated in
technological pharmacy (IPI) and management (ISMA). He is
currently a GMP auditor within the International Committee
of the Red Cross (ICRC). He was previously the Head of the
Pharmaceutical and Cosmetics Inspection Department at the
French Health Products Regulatory Agency (Afssaps). He also
used to work in or with the pharmaceutical industry during
12 years at various positions including Quality Assurance,
Production Management, Engineering and GMP Consulting.

Andreas Nuhn, Carpus & Partner AG – Germany

Andreas Nuhn has an university degree in process engineer-
ing. He has a wide diversified experience in pharmaceutical
engineering beginning with cleanroom technology, clean
media generation and distribution systems up to special
process technologies e.g. in blood plasma fractionation.
Moreover, he is using his experience and expertise by
working as an GMP-auditor worldwide. He worked for NNE
Pharmaplan for many years and was responsible for
Technology Consulting. Since 2007 he is working for Carpus
& Partner AG.

Jolande Schoemaker, Schoemaker Consultancy –

The Netherlands
Jolande Schoemaker is currently located in The Netherlands
and works as a consultant to the pharmaceutical industry.
Previous to her current role she was the Director Quality
Affairs at Crucell. Jolande gained a wide field of experience
in many aspects of the pharmaceutical and biotechnology
industry, including formulation of drugs, manufacturing of
sterile pharmaceutical products, hospital care and clinical
trials, Regulatory Affairs, Quality Control and Quality
Assurance. Furthermore, she was involved in many regula-
tory inspections, including some conducted by the US FDA,
the Canadian and the British Inspectorate.

Andreas Wokittel, Lauterbach + Söhne GmbH – Germany

Andreas Wokittel studied Energy and Environmental
Engineering. He is member of several boards, for example in
the National Executive Committee of the VDI for facility
technology (HVAC) and in the technical board of the
industry association for Heating, HVAC, Sanitation (BHKS). In
this position he participated in the compilation of many VDI-
standards. Andreas Wokittel has more than 20 years of
industry experience and is now CEO of Lauterbach & Söhne
GmbH.
 Reservation Form (Please complete in full)
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please fill out here: Clean Rooms
10 –12 June 2008, Barcelona, Spain

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CONCEPT HEIDELBERG
Street/P.O. Box
P.O. Box 101764
Fax +49 (0) 62 21/84 44 34
City Zip Code Country
D-69007 Heidelberg
GERMANY
Phone Fax E-Mail (please fill in)

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Date
Tuesday, 10 June 2008, 10.00 -18.30 h
(Registration and coffee 09.30-10.00 h)
Wednesday, 11 June 2008, 09.00 – 18.30 h
Thursday, 12 June 2008, 08.30 – 13.00 h
Venue
NH-Hotel Constanza
C/ Deu i Mata 69-99
28029 Barcelona
Tel +34 93 281 15 00
Fax +34 93 281 15 14
Fees
Non-ECA Members EUR 1.990.- per delegate plus VAT
ECA Members EUR 1.791.- per delegate plus VAT
APIC Members EUR 1.895.- per delegate plus VAT
(does not include ECA Membership)
EU GMP Inspectorates € 995.- per delegate plus VAT
The conference fee is payable in advance after receipt of
invoice and includes conference documentation, dinner on the
first day, lunch on both days and all refreshments. VAT is
reclaimable.
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of
rooms in the NH Hotel Constanza. Reservation should be made
directly with the hotel not later than 9 May 2008. You will
receive a room reservation form when you have registered for
the course. Please use this form for your room reservation or be
sure to mention “VA 5591 ECA Course” to receive the specially
negotiated rate for the duration of your stay. 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 official conference language will be English.
General Terms of Business
If you cannot attend the conference you have two options:
1. We are happy to welcome a substitute colleague at any time.
2. If you have to cancel entirely, we must charge the following
processing fees: Cancellation
 until 2 weeks prior to the conference 10 % of the
registration fee.
 until 1 week prior to the conference 50 % of the
registration fee.
 within 1 week prior to the conference 100 % of the
registration fee.
CONCEPT HEIDELBERG reserves the right to change the
materials, instructors, or speakers without notice or to cancel
an event. If the event must be cancelled, registrants will be
notified 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.
Terms of payment: Payable without deductions within 10 days
after receipt of invoice.
Important: This is a binding registration and above fees are due
in case of cancellation or non-appearance. If you cannot take
part, you have to inform us in writing. The cancellation fee will
then be calculated according to the point of time at which we
receive your message. In case you do not appear at the event
without having informed us, you will have to pay the full
registration fee even if you have not made the payment yet. You
are not entitled to participate in the conference until we have
received your payment (receipt of payment will not be
confirmed)!
Organisation and Contact
CONCEPT HEIDELBERG
P.O.Box 10 17 64
69007 Heidelberg, Germany,
Phone ++49-62 21/84 44-0 , Fax ++49-62 21/84 44 84
info@concept-heidelberg.de
www.concept-heidelberg.de
For questions regarding content:
Dr Robert Eicher (Operations Director) at
+49-62 21 / 84 44 12 or per e-mail at
eicher@concept-heidelberg.de.
For questions regarding reservation, hotel, organisation etc.:
Ms Nicole Bach (Organisation Manager) at
+49-62 21 / 84 44 22 or per e-mail at
bach@concept-heidelberg.de.
What Is ECA?
The European Compliance Academy (ECA) is an independent
educational organisation chaired by a Scientific Advisory Board
with members of the pharmaceutical industry and regulatory
authorities.
The ECA will provide support to the Pharmaceutical Industry
and Regulators to promote the move towards a harmonised set
of GMP and regulatory guidelines by providing information and
interpretation of new or updated guidances.
What Are the Benefits of ECA?
First benefit:
During the membership, you enjoy a 10 % discount on the
regular participation fee of any European Conference organ-
ised by ECA in co-operation with CONCEPT
HEIDELBERG.
Second benefit:
The GMP Guidelines Manager Software
with a large number of guidelines, e.g.
EC Directives, FDA Guidelines, ICH
Guidelines, will be forwarded to you
when you are using your membership
for a conference registration.
How Do You Become a Member of ECA?
By participating in one of the European Compliance Confer-
ences or Courses marked with ECA, you will automatically
become a member of ECA for two years – free of charge.
Conferences and Education Courses organised by ECA will be
realised in co-operation with CONCEPT HEIDELBERG.
More information about ECA can be obtained on the website
http://www.gmp-compliance.org.