Annex 1 Conference - European Compliance Academy

ECA
E
C
ACADEMY
UROPEAN
OMPLIANCE
In combination with
CleanRooms Europe
Exhibition
Speakers
Martyn Becker
Martyn Becker Associates
Image: Groninger
Klaus Eichmüller
GMP Inspector, District
Government of Upper
Bavaria
Dr Klaus Haberer
Compliance Advice and
Services in Microbiology
Dr Friedrich Haefele
Vice President Biopharma
Operation, Boehringer
Ingelheim
Dr Christian SchrÖter
Director Liquid Production,
Merck KGaA
Annex 1 Conference
Revision of Annex 1
EU GMP Guide “Manufacture
of sterile medicinal products”
23 March 2009, Stuttgart, Germany
highlights:
•
The Revision of Annex 1 to the EU GMP
Guide – View of a GMP Inspector
Changes Regarding Clean Rooms and
Clean Air Classification and Monitoring
Microbiological Requirements According
to Annex 1
Capping and "Grade A"
Restricted Access Barrier Systems (RABS)
– Isolators and “Classical” Clean Rooms –
Which Technique to Be Used for the
Different Pharmaceutical Operations
•
•
•
•

Invitation
Join this important Annex 1 Conference and visit Europe's leading exhibition
CleanRooms Europe – free.
The Annex 1 Conference will take place the day before the CleanRooms Europe
Exhibition will open its doors from March 24 – 26.
About CleanRooms Europe
Since launching in Frankfurt in 1998, CleanRooms Europe has become
Europe's premier event for linking contamination control, infection control,
and personnel-protection production and solution providers with target buyers
and specifiers. The show provides both a shop front and knowledge exchange
forum for international professionals working in the rapidly-expanding
range of industries requiring clean or ultraclean manufacturing processes and
facilities. The 10th anniversary event held 11 - 13 March 2008 at the state-ofthe-art
Neue Messe Stuttgart set record attendance. More than 2,600 participants
from 62 countries attended the show. Of the more than one third of attendees
who visited from outside Germany, 13 per cent travelled to Stuttgart
from non-EU European Countries, Asia, the Middle East, the Americas, and Africa
- making CleanRooms Europe a truly international event.
Participants of ECA's Annex 1 Conference will receive a ticket for free
entrance to the exhibition and a voucher for an extra 10 % discount for
the additional courses offered during CleanRooms Europe, e.g.:
One-day Course Programme: Tuesday, 24th March 2009
Contamination Control Essentials, Dr. H. H. Schicht, Zumikon/Switzerland
The regular price is € 315.- , the 10% discounted price for Annex 1 delegates
would be € 285.-
More details about the upcoming events at CleanRooms Europe can be
found here: www.cleanrooms-europe.com
Objectives
The EU GMP Guide Annex 1 on the manufacture of sterile medicinal products
is among the most important GMP guidelines for industry. After an intensive
discussion the new version has been finalized with a number of changes. The
aim of this conference is to provide an overview about the changes as well as
practical examples for the implementation. Speakers from industry as well as a
representative from an EU GMP Inspectorate will focus on the different critical
areas changed in the current version of Annex 1.
Background
Since the first publication of Annex 1 (Manufacture of sterile medicinal products)
together with the GMP Guide, it has already been revised three times - in
1996, 2001 and in 2003. On 15 February 2007, the European Commission published
the modified version. The requirements laid down in this document
have to be implemented by the industry by 1 March 2009. For the capping of
lyophilised vials, the transition period has been extended to 1 March 2010.
The following changes to the current version have been made:
• The classification of clean rooms and associated explanations
• Recommendations with regard to media fills
• Recommendations with regard to bioburden monitoring
• Recommendations with regard to capping for freeze-dried vials
Target Audience
The event is directed at all those working in the field of sterile manufacturing
who have to implement the new requirements in order to achieve EU GMP
compliance.

Programme
The Revision of Annex 1 to the EU GMP Guide – View of a GMP Inspector
• Annex 1 - Overview
• Clean room classification - qualification and monitoring
• Media fills - what`s new
• Bioburden monitoring - changes
• Capping of freeze-dried vials - an aseptic operation?
• Inspection considerations
Klaus Eichmüller
GMP Inspector
Changes regarding Clean Rooms and Clean Air Classification and
Monitoring
• Qualification and re-qualification with the new Annex 1 in the
different cleanroom classes
• Monitoring according to Annex 1 in the past and in the future
− How to take the samples?
− How to calculate?
• How to change SOPs for measurement procedures
martyn becker
Martyn Becker Associates
Image.: CCI - von Kahlden
Microbiological Requirements According to Annex 1
• Environmental monitoring
• Media fill
• Microbiological implications of the new requirements for capping
• New Rapid Micro Methods for clean room monitoring
Dr Klaus Haberer
Compliance Advice and Services in Microbiology
Capping and "Grade A": Our Solution
• Introduction: Layout and design of the vial filling line
• Design of the capping station
• Evaluation of the new requirements
• Conclusion
Dr Christian SchrÖter
Director Liquid Production, Merck KGaA
Restricted Access Barrier Systems (RABS) – Isolators and “Classical”
Clean Rooms – Which Technique to Be Used for the Different
Pharmaceutical Operations/Processes
•
•
•
Regulatory aspects
Definitions
Design principles
Decision process: What? When? How?
•
Dr Friedrich Haefele
Vice President Biopharma Operation, Boehringer Ingelheim

Speakers
Martyn Becker
Martyn Becker Associates
Martyn Becker has worked in the pharma industry since 1974,
predominantly in the area of sterile manufacturing. Following
20 years at SmithKline Beecham (now GSK), Martyn spent 5
years at MHRA, the UK regulatory agency. In 2000 he left
MHRA to join Merck & Co., where he designed and implemented
global harmonised aseptic processing standards within Merck. Martyn
has liaised with FDA and EMEA regarding the updating of regulatory guidance
documents and speaks regularly on the subject of aseptic processing for PDA,.
Martyn now works as a pharmaceutical consultant, directing Martyn Becker
Associates, a GxP consultancy based in the UK, with global reach.
Klaus Eichmüller
District Government of Upper Bavaria Munich,
GMP Inspectorate
After working in the pharmaceutical industry Klaus Eichmüller
joined the District Government of Upper Bavaria in Munich.
Since 1996 he has been working in the field of GMP inspections
of manufacturers of medicinal products and importers. He is
Deputy Head of the Central Surveillance of Medicinal Products in Bavaria.
Dr Klaus Haberer
Compliance Advice and Services in Microbiology GmbH
Dr Haberer was Head of Microbiological Quality
Control at Hoffmann-La Roche AG, Grenzach, Germany, and
later Head of Microbiological Quality Control and Director
Microbiology Global Quality Operations at Hoechst Marion
Roussel AG in Frankfurt, Germany. Since 1999 he is Managing
Director of Compliance Advice and Services in Microbiology GmbH. Dr Haberer
is working as an expert in a number of international committees, e.g. of
European Pharmacopoeia, ISO, and PDA.
Dr Friedrich Haefele
Boehringer Ingelheim
Dr Haefele has been in the pharmaceutical industry for almost
20 years now. In May 2006 Dr Haefele joined Boehringer Ingelheim
Pharma as Vice President in the business domain Biopharmaceuticals.
He is responsible for the department Biopharma
Operations, managing the Aseptic Processing of Biopharmaceuticals
to Drug Products filled into Vials and Pre-filled Syringes.
Dr Christian Schröter
Merck KGaA
Dr Schröter is currently Director of Liquid Manufacturing responsible
for making, filling and packaging of sterile and nonsterile
liquids. Before commercial manufacturing, he was working
in various positions in pharmaceutical development.
.

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 organised 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
Conferences 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
GMP Certification
Programme
By attending selected seminars, the participant can acquire an additional
certificate. We offer the following certification modules:
• Certified Quality Assurance Manager –
Pharmaceutical Production (ECA)
• Certified Quality Assurance Manager – API Production (ECA)
• Certified Quality Control Manager (ECA)
• Certified Pharmaceutical Engineering Manager (ECA)
• Certified Computer Validation Manager (ECA)
• Certified Regulatory Affairs Manager (ECA)
• Certified Validation Manager (ECA)
On the Internet at www.gmp-compliance.org you
will find a text explaining which seminars are recognised
for which certificates.
Or you send an e-mail to
info@gmp-compliance.org or a fax to
+49-6221-84 44 64 with the request for information
about the GMP Certification Programme.
We will then send you our brochure
on the topic.

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
Monday, 23 March 2009, 9.30 – 17.00 h
(Registration and coffee 9.00 – 9.30 h)
Venue
Mövenpick Hotel Stuttgart Airport
Flughafenstraße 50
70629 Stuttgart, Germany
Phone 0049 (0)711 55344 0
Fax 0049 (0)711 55344 9000
Conference fees
ECA Members € 620.- per delegate plus VAT
APIC Members € 655.- per delegate plus VAT
(does not include ECA Membership)
Non-ECA Members € 690.- per delegate plus VAT
EU GMP Inspectorates € 345.- per delegate plus VAT
The conference fee is payable in advance after receipt of
invoice and includes conference documentation, lunch
and all refreshments. VAT is reclaimable.
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in
the conference hotel. You will receive a room reservation form
when you have registered for the event. Please use this form for
your room reservation or be sure to mention “VA 5954 ECA Event”
to receive the specially negotiated rate for the duration of your
stay. Reservation should be made directly with the hotel not later
than 22 February 2009. 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.
Organisation and Contact
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
ECA has entrusted CONCEPT HEIDELBERG with the organisation
of this event.
For questions regarding content:
Oliver Schmidt (Operations Director) at +49-62 21/84 44 23,
or by e-mail at schmidt@concept-heidelberg.de.
For questions regarding reservation, hotel, organisation etc.:
Ms Susanne Ludwig (Organisation Manager) at +49-62 21/84 44 44,
or by e-mail at ludwig@concept-heidelberg.de.
If the bill-to-address deviates from the specification
to the right, please fill out here:
Reservation Form (Please complete in full)
Annex 1 Conference
23 March 2009, Stuttgart, Germany
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+49 6221 84 44 34
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CONCEPT HEIDELBERG
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General terms and conditions
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 %,
• until 1 weeks prior to the conference 50 %
• within 1 week prior to the conference 100 %.
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. Only after we have received your payment, you are entitled to
participate in the conference (receipt of payment will not be confirmed)!
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