3-Day GMP Education Course June 2008, Barcelona, Spain

Transcription

1 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 June 2008, Barcelona, Spain SPEAKERS: Danny Van Dyck, MBA Cilag AG, Switzerland Dr Udo Gommel Fraunhofer Institute IPA, Germany Dr Robert Johnson Dialogue, Switzerland Thomas von Kahlden CCI - von Kahlden GmbH, Germany Dr Jean-Denis Mallet Formerly Head of the French Pharmaceutical Inspection Department, France Andreas Nuhn Carpus & Partner AG, Germany Jolande Schoemaker Schoemaker Consultancy, The Netherlands Andreas Wokittel Lauterbach + Söhne GmbH, Germany LEARNING OBJECTIVES: Regulatory Requirements and cgmp Compliance Guidelines and Technical Standards Clean Room Design Layout: Walls, Ceiling, & Floor Zone Concepts Engineering of Clean Rooms Implementation and Operations of HVAC Systems Equipment Design for Clean Room Use Risk based Qualification and Validation Qualification according to ISO Standards and GMP Guides Microbial Validation Environmental Monitoring Techniques cgmp Compliant Clean Room Operation Data Interpretation and QA Actions Cleaning and Cleaning Validation

2 Clean Rooms 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. Pragmatic, cost effective and scientifically sound advice on compliance to the technical requirements in the projectand 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 development of a design specification (URS) are the main topics of this part. Qualification/Validation You will learn how to choose and correctly use measurement 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 provisions 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 contamination 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 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 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 requirements for the layout of clean rooms are listed, but without 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

3 Qualification of Clean Rooms according to ISO 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 discussed. Examples of measurements and their documentation 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 subsequent 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 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 Social Event Speakers 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. 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 In 2000 he became Project Leader for Sterility Technology and Senior Project Manager Engineering R&D for Cilag in Additionally 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 Dr Udo Gommel, Fraunhofer IPA Germany Udo Gommel studied Physics and works at the Fraunhofer Institute for Manufacturing Engineering and Automation (IPA) since 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 Since 2008 is Head of the Ultraclean Technology and Micromanufacturing department of the Fraunhofer IPA in Stuttgart.

4 Dr Robert Johnson, Dialogue Switzerland Robert Johnson is currently the CEO of Dialogue, a consultancy 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 Pharmacopoeia. 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 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 Pharmaceutical 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 engineering. 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 regulatory 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 VDIstandards. Andreas Wokittel has more than 20 years of industry experience and is now CEO of Lauterbach & Söhne GmbH.

5 If the bill-to-address deviates from the specifications on the right, please fill out here: Please fill in PO Number if applicable CONCEPT HEIDELBERG P.O. Box Fax +49 (0) 62 21/ D Heidelberg GERMANY Reservation Form (Please complete in full) Clean Rooms June 2008, Barcelona, Spain * Mr * Ms Title, first name, surname Company Department Important: Please indicate your company s VAT ID Number Street/P.O. Box City Zip Code Country Phone Fax (please fill in) #

6 Date Tuesday, 10 June 2008, h (Registration and coffee h) Wednesday, 11 June 2008, h Thursday, 12 June 2008, h Venue NH-Hotel Constanza C/ Deu i Mata Barcelona Tel Fax Fees Non-ECA Members EUR per delegate plus VAT ECA Members EUR per delegate plus VAT APIC Members EUR per delegate plus VAT (does not include ECA Membership) EU GMP Inspectorates 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 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 or by fax message. Or you register online at 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 Heidelberg, Germany, Phone / , Fax / info@concept-heidelberg.de For questions regarding content: Dr Robert Eicher (Operations Director) at / or per at eicher@concept-heidelberg.de. For questions regarding reservation, hotel, organisation etc.: Ms Nicole Bach (Organisation Manager) at / or per 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 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