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].