How to Pass EU and FDA Inspections 3-Day GMP Education Course

3-Day GMP Education Course
 An EU Inspector will povide
the regulatory insight
 FDA and EU aspects are
covered
 4 workshops
How to Pass EU and FDA Inspections
& GMP Compliance Auditor Course
8 – 10 June 2009, Berlin, Germany
SPEAKERS:
PROGRAMME:
Dr Martin M. Appel
Cilag AG, Switzerland
 Regulatory Overview:
- What do Authorities expect
- How Inspectors are trained
- Regulatory Inspections
- Typical Compliance Issues
Richard M. Bonner
formerly Eli Lilly and Company
Limited, U.K.
Dr Jean-Denis Mallet
International Committee Red Cross,
formerly Head of the French Pharmaceutical
Inspection Department
John Taylor
Medicines and Healthcare Products
Regulatory Agency, U.K.
 Preparing and performing an audit:
- What makes a good Auditor
- Performance and Follow-up of
Audits
- Risk-based Audit Schedule
 Preparing for a GMP-Inspection:
- Successful Preparation
- Tools to manage an Inspection
- Dos and Don’ts
How to Pass EU und FDA Inspections & GMP Compliance Auditor Course
8 – 10 June 2009, Berlin, Germany
Objectives
Programme
The purpose of this course is to treat the topic of auditing
from a practical perspective including EU and US aspects.
Overview
Being inspected and performing an audit are activities
which are closely linked. The latter is an essential tool for
the preparation of any inspection. Hence you will learn
both aspects in this course: inspection preparation and
conducting audits.
Three parallel workshops on the topics:
 Preparing for an FDA Inspection
 Audit of an API manufacturer
 Know your GMPs
and an additional workshop on
 How to make an risk-based audit schedule
complete the event and promote the translation from
theory to practice.
Background
GMP audits and inspections are fundamental elements
of managing quality assurance in the pharmaceutical
industry. On the one hand, pharmaceutical enterprises
perform supplier audits (including APIs, excipients and
packaging material), and on the other hand, the pharmaceutical companies as well as the active ingredient manufacturers are frequently inspected by the authorities
(e.g. national inspectorates, FDA) and customers as a
central element of supervision.
For the audited enterprise, an inspection can have a decisive influence on its economic future. A sound and
thorough preparation is an essential key.
Moderator
The Challenges of GMP Audits
 Regulatory Requirements
 Purposes and Reasons for GMP audits
 Audit types
Dr Jean-Denis Mallet
Typical compliance issues
 Quality System
 Laboratory control
 Production
 Material Management
 Facility & equipment
 Packaging and labelling
Dr Martin Appel
Preparing and performing a GMP audit
How to perform and follow-up an Audit
 Audit program and planning
 Performing the audit
 Audit reports and rating systems
 Response to the audit report
 Action plan and tracking major observations
 Re-audit
Dr Martin Appel
The One-day Audit - How to get a quick Assessment of
a Company State of Compliance
 Reviewing facilities
 Warehouse, receipt and sampling areas
 Bulk production and final formulation areas
 Packaging departments
 Laboratories and stability
 HVAC systems and computers
 Auditing manufacturing documentation
Richard M. Bonner
Richard M. Bonner
Target Group
This GMP Education Course is designed for all persons
involved in conducting, preparing and evaluating audits
and inspections. It is also addressed to interested parties
from regulatory authorities.
Note: The number of participants is limited.
What makes a good inspector
 How inspectors are trained
 Skills needed
 Information transfer between inspectorates
John Taylor
Workshop
How to make a risk-based Audit Schedule
Richard M. Bonner
 Understand how to assess risk between different
operations
 Identify priorities for the audit
 Learn how to use a point system to assign audit
priorities based on risk
 How to use a template to make a risk-based audit
schedule
Preparing for a GMP Inspection
Auditing Your Company to prepare for international
Inspections
 Internal audit expectations
 Audit hierarchy
 EU and FDA cGMP differences
 Quality System audit details
 Audit strategy and cycle
 Rolls and Responsibilities
Richard M. Bonner
Tools to successfully manage Regulatory Inspections
 ‚Features of on-line communication tools, e.g. NetMeeting, WebMeeting‘
 Lay-out of the Back Room
 Inspection workflow and definition of functions
 Docket system
Dr Martin Appel
Regulatory View
What do authorities expect?
 FDA System-based Inspections – an overview
 Inspections in the US
 The quality system is the focus
 Experiences from an ex-inspector’s point of view
Dr Jean-Denis Mallet
Parallel Workshops
We offer three parallel workshops in the morning and
in the afternoon. You will be able to attend 2 of these
parallel sessions. Please choose the ones you like to
attend on when you register for the course.
Workshop 1 Preparing for a Regulatory Inspection
Dr Martin Appel
 Pre-inspection team
 Gap analysis (e.g. mock inspection)
 Action plan and list of responsible persons
 Training of the staff (dos and don‘ts, argumentation,
presentation)
 Function of moderator, escorts and experts
 The opening day
 Trouble shooting /Procedure after findings
Workshop 2 Risk analysis related to the inspection/audit findings
Dr Jean-Denis Mallet
Workshop 3 Know your GMPs
Richard M. Bonner
 An interactive review of different GMP scenarios
which will test the participants knowledge of GMPs
and enable detailed discussions on the implications
of the actions taken.
Regulatory Inspections: The View of a UK Inspector
 Introduction of MHRA GMP inspections
 Classification of GMP deficiencies/Examples of critical
deficiencies
 MHRA inspection findings 2004/2005 for API sites,
tissue banks and blood centres
 Risk assessment in the audit process
 Inspection outcome measures
 EMEA compilation of community procedures on
inspections and exchange of information
 The future
John Taylor
Social Event
The European Compliance Academy (ECA) and
CONCEPT HEIDELBERG cordially invite the conference
participants to join them and the speakers for a social
event on Monday evening in Berlin. During an informal
dinner you will have the opportunity to share your experiences and discuss the hot topics of the day with your
land. 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.
colleagues.
Speakers
Dr Martin M. Appel
Cilag AG, Schaffhausen, Switzerland
Dr Appel holds a Master Degree in chemistry, a PhD nat.
sci. from the University of Hohenheim, Stuttgart and a
Master Degree of Business Administration from the GSBA
Zürich and State University of New York. Martin Appel has
20 years experience in several manager positions in the
pharmaceutical industry at F. Hoffmann-La Roche and
within Johnson&Johnson. As QA Director he acted as liaison during official inspections from e.g. FDA, EU, SwissMedic as well as during customer audits and performed
in-house audits and GMP Inspections at suppliers. Since
2008 he is QA Director for External Manufacturing for the
Worldwide Chemical Production of Johnson & Johnson.
Richard M. Bonner
Formerly with Eli Lilly, United Kingdom
Mr Bonner is currently located in the UK and works as a
consultant to the Pharmaceutical Industry. Previous to
his current role he was a Senior Quality Adviser for Eli Lilly and Company. He had 31 years experience within the
pharmaceutical industry working in production, technical services and both Quality Control and Quality Assurance functions. He has been involved in multiple inspections from the MHRA, FDA and other authorities. He has
also been instrumental in obtaining ISO9000-2000 accreditation for manufacturing sites. He has audited extensively throughout the EU and in countries as far a field
as Canada, USA, China, Pakistan, Egypt, Syria, Oman and
Russia. Mr Bonner is a Qualified Person in Europe. He is
now Associate Partner with Concept Heidelberg.
Jean-Denis Mallet, PhD
International Committee Red Cross,
formerly Head of the French Pharmaceutical Inspection Department
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) in Geneva, Switzer-
John Taylor
Medicines & Healthcare Products Regulatory Agency
(MHRA), London, United Kingdom
John Taylor is Quality and Standards Manager Acting and
Group Manager, Enforcement and Intelligence of the
UK Medicines and Healthcare Products Regulatory Agency (formerly the Medicines Control Agency). John joined
the MCA in 1991 after working in the pharmaceutical industry for 24 years in quality assurance, quality control,
research and development and regulatory affairs. following two years as a Medicines Inspector, he joined the Policy, Borderline and Standard Group to develop a quality
system for the MCA’s Medicines Inspectorate and to obtain, maintain and extend the scope of MCA’s certification
to ISO 9002. John is currently responsible for all quality
matters within the Inspection and Enforcement Division.
John is a Chartered Chemist, a Fellow of the Royal Society
of Chemistry and a member of the British Institute of Regulatory Affairs.
The ’tool’ for every auditor
Every participant will receive the
GMP Guideline Manager Software,
free of charge. This CD contains almost 13,000 pages of ICH, FDA and
EC guidelines. In the office or on the
laptop during inspections, the CDROM is a useful tool for verifying, for
example, whether a particular requirement is really laid down in the
guidelines or not.
The Three Most Important Guidelines and Comparison
Matrix in One Booklet
The European Compliance Academy (ECA) has developed a
Good Practice Guide „FDA cGMP, EU / PIC/S GMP and ISO
9001 Matrix for a pharmaceutical Quality System“. This Roadmap includes the full-text version of the three Guidelines:
GMP Certification Programme
This seminar is recognised within the 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
FDA‘s cGMP Guide (21 CFR 210/211)
PIC/S GMP Guide incl. Annex 18 / ICH Q7A (identical with
EU GMP Guide)
ISO 9001 on Quality Management Systems
The three Guidelines will be supplemented by a GMP/ISO Matrix that compares the requirements of all three Guidelines. The
booklet contains 20 pages of the GMP Matrix and 390 for the
three Guidelines.
You can purchase the booklet that is printed in an easy-to-use
format on the Internet at www.gmp-compliance.org. If you do
so, you will be granted the ECA Members price of 99.- € (plus
VAT and shipping costs). The regular price is 149.- € (plus VAT
and shipping costs).
About CONCEPT HEIDELBERG
Founded in 1978, CONCEPT HEIDELBERG is the leading organiser of seminars on pharmaceutical production, quality control,
quality assurance and GMP in Europe. This year more than 240
events will be organised by CONCEPT HEIDELBERG.
ECA has entrusted CONCEPT HEIDELBERG with the organisation of its events.
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 Guideline 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
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 [email protected] 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.
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
E-Mail (please fill in)
Phone/Fax
City
Country
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)!
Zip Code
P.O. Number if applicable
Reservation Form:
+ 49 6221 84 44 34
#
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 %.
D-69007 Heidelberg
GERMANY
Department

Street/P.O. Box
Important: Please indicate your company’s VAT ID number
Company
+ 49 6221 84 44 34
P.O. Box 10 17 64
69007 Heidelberg
Germany
CONCEPT HEIDELBERG
P.O. Box 101764
Fax +49 (0) 62 21/84 44 34
*
Ms.
Title, first name, surname
*Mr.
Please indicate the 2 workshops you want to participate in:
 Workshop 1: Preparing for an FDA inspection
 Workshop 2: Risk analysis related to the inspection/audit findings
 Workshop 3: Know your GMPs
8 – 10 June 2009, Berlin, Germany
How to Pass EU and FDA Inspections & GMP Compliance Auditor Course
Reservation Form (Please complete in full)
Form:
 Reservation
CONCEPT HEIDELBERG
If the bill-to-address deviates from the specifications on the right,
please fill out here:
Easy Registration
Internet:
@ e-mail:
[email protected]  www.gmp-compliance.org
Date
Monday, 8 June 2009, 10.00 h – 18.00 h
(Registration and coffee 09.00 h -09.30 h)
Tuesday, 9 June 2009, 09.00 h - 18.00 h
Wednesday, 10 June 2009, 08.30 h - 14.30 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
Non-ECA Members: € 1.990,- per delegate + VAT.
ECA Members: € 1.791,- per delegate + VAT.
APIC Members: € 1.890,- per delegate + VAT
EU GMP Inspectorates: € 995,- per delegate + VAT.
Including: Conference documentation, lunch and
dinner on the first day, lunch on the second and third
day, all refreshments, social event
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 5865 ECA
Course” to receive the specially negotiated rate for the
duration of your stay. Reservation should be made
directly with the hotel not later than 7 May 2009. Early
reservation is recommended.
Registration
Via the attached reservation form, by e-mail or by fax
message. Or you register online at www.gmpcompliance.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: [email protected]
www.concept-heidelberg.de
For questions regarding content:
Wolfgang Schmitt (Operations Director)
at +49-62 21/84 44 39, or per e-mail at
[email protected]
For questions regarding reservation, hotel,
organisation etc.:
Detlef Benesch (Organisation Manager)
at +49-62 21 / 84 44 45, or per e-mail at
[email protected].