Pharmaceutical Laboratory Manager

Speakers: Dr Christopher Burgess Burgess Analytical Consultancy, UK Dr Bob McDowall McDowall Consulting, UK Dr Matthias Heuermann (European GMP Inspector) LIGA.NRW, Germany Dr Bernd Renger Bernd Renger Consulting, Germany The Pharmaceutical Laboratory Manager 2011 How to Efficiently Manage cgmp Compliance in Analytical Labs New cgmp Requirements for QC Labs Increasing Analytical Labs Efficiency and Effectiveness 10-11 October 2011, Amsterdam, The Netherlands This conference is recognised for the ECA GMP Certification Programme Certified Quality Control Manager. Please find details at www.gmp-certification.eu

The Pharmaceutical Laboratory Manager 2011 10-11 October 2011, Amsterdam, The Netherlands Objectives Background The objectives of this conference are to provide guidance on ways of attaining best regulatory practice and to review the quality management tools available to increase laboratory throughput whilst maintaining data quality. This conference will address new GMP requirements for analytical laboratories and it will also present tools for an efficient and effective laboratory operation. The challenges laboratory managers are facing today is how to keep pace with rapidly changing regulatory needs and, at the same time, to increase analytical output with current or fewer resources. Pharmaceutical laboratory managers must be familiar with many GMP-related topics, such as; Latest EU and US (FDA) GMP requirements Quality management systems and approaches, Pharmacopoeial requirements, Data integrity (paper and electronic records), Risk management, Measurement uncertainty of reference standards (CRS), Out of Specification Results, Analytical instrument qualification, and many more On the other hand, management expects that laboratory managers operate their laboratory activities in an effective and efficient way. Laboratory managers must know how to manage costs in the analytical laboratory and must also know those Key Performance Indicators (KPIs), which are relevant for the performance of their labs and be aware of benchmarking against typical KPIs in their industry. This also includes getting to know new tools as the introduction of deviation management and CAPA in the analytical laboratory and the use of system suitability testing and method robustness as an example for a specific and effective activity to reduce deviations. Participants will discuss how to use experimentally designed robustness studies to identify critical factors and how to set acceptance criteria for critical factors to minimise OOS, OOE and OOT results. This conference will explore concepts for increasing analytical lab s efficiency and effectiveness and will discuss potential benefits for QC labs. Target Audience This conference will be of significant value to Laboratory managers Quality control managers Analytical scientist Senior laboratory staff who are responsible for GMP compliance and Laboratory Organisation. Moderator Dr. Christopher Burgess Burgess Analytical Consultancy Limited, UK Social Event On Monday evening, 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.

Programme Introductory Lecture: GMP in Daily Laboratory Routine Tightened FDA approach to GMP Inspections Defining Raw Data to Meet the New Requirements of EU GMP Annex 11 and Chapter 4 Roles and Responsibilities QA, Head of QC and QP Can the Batch Release Decision be Influenced by the Measurement Uncertainty of the CRS? Out of Specification Results US Requirements and new Developments in Europe A Risk-Based Approach to Laboratory Instrument Qualification (includes Workshop I) Part I: Compliance New cgmp Requirements for QC Labs The various rules and guides regulating the Laboratory... Additional expectations - nice to have or must? Pharmacopoeias and GMP The freedom of the analyst... Typical errors and mistakes Key Quality Systems the main focus of the FDA Differences to European Guidelines are there any? Focus: Integrity of testing documentation cgmp Deficiencies cited in latest Warning Letters and what we can learn from them Trends and outlook for future FDA inspections From 30th June 2011, there is a new EU GMP requirement in Chapter 4 and Annex 11 to define raw data for all systems generating results used for batch release. This includes both hybrid systems (paper printouts of electronic records) and electronic records used in GMP activities. The presentation will discuss: Why definition of paper as raw data is now insufficient Definition of raw data for hybrid systems Definition of raw data for electronic systems Protection and backup of raw data Validation of measures to protect and backup raw data Dr Bob McDowall, McDowall Consulting, UK Head of QC - legal and regulatory expectations QA, QC, Compliance, QP - what do we really need? Quality Management Systems and new chapter 1& 2 - what s changing? Processes versus hierarchy and organisation... Market authorisation and GMP-surveillance in Europe Chemicals and Reagents in GMP guidelines CRS, Characterisation of standards Measurement uncertainty of standards Requirements of EN ISO/IEC 17025 Points under discussion USP viewpoint Possible impact on the release decision Dr Matthias Heuermann, LIGA.NRW, Germany FDA Final Guidance 2006; what changed since the 1998 draft Implications and Warning Letter citations EU position on OOS results & investigations MHRA initiative on OOS 2010 ECA Analytical Quality Control Working Group on a unified and harmonised approach to the management of laboratory deviations Dr Christopher Burgess, Burgess Analytical Consultancy, UK A scalable model for a risk based approach to integrated instrument qualification and computerised system validation of laboratory instruments will be presented and discussed over three short talks. After each talk there will be either a facilitated discussion or a workshop to reinforce the principles of the talk. To illustrate the principles of the integrated approach an analytical balance, an NIR spectrometer used for raw materials identification and a networked chromatography data system will be used to show the scalable nature of the model. Dr Christopher Burgess, Burgess Analytical Consultancy, UK Dr Bob McDowall, McDowall Consulting, UK

Programme How to Manage Costs in Analytical Laboratories / Typical Key Performance Indicators (KPIs) in Analytical Laboratories Part II: Increasing Analytical Labs Efficiency and Effectiveness Performance indicators or key performance indicator? Examples of meaningful and useless indicators (financial, performance & productivity, quality, etc.) Long term and short term considerations Measurability of indicators Indifferent, complementing, and competing key performance indicators Balanced scorecard WORKSHOP II KPIs for a Meaningful Benchmarking Part I The attendees will be given a QC laboratory overview with a flow diagram and will be asked to suggest practical KPIs for efficiency and effectiveness of the lab and to discuss pitfalls in setting benchmarking KPIs to compare across laboratories. Part II Attendees will be supplied with HPLC analysis time data and graphs and asked to design lead time KPIs with success targets. Moderators: Dr Chris Burgess, Dr Bob McDowall, Dr Bernd Renger Deviation Management and CAPA for an Efficient and Effective Laboratory Operation Deviation management in the laboratory is assuming a greater importance for both laboratory operations and incident management for laboratory computerised systems. We will discuss the following: Unified and streamlined approach for deviation management Analysing the current manual / semi automated process Automating an electronic process for efficient and effective deviation management Dr Bob McDowall, McDowall Consulting, UK WORKSHOP III Efficient and Effective Deviation Management Attendees, working in groups, will be presented with a current laboratory process for handling deviations and CAPA together with the current process bottlenecks. The groups will work together to improve the process and make it efficient and effective. Moderator: Dr Bob McDowall System Suitability Testing and Method Robustness as one means of Reducing Deviations Why do we need system suitability tests? Analytical procedure; methods or holistic processes? What do we mean by ruggedness of analytical procedures? Are robustness and ruggedness the same thing? Use of experimentally designed robustness studies to identify critical factors Setting acceptance criteria for critical factors to minimise OOS, OOE & OOT results Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Speakers Dr Christopher Burgess, Burgess Analytical Consultancy Limited, UK Chris Burgess is an elected member of the USP Council of Experts on General Chapters, 2010-2015 and member of the Qualified Person Association Advisory Board. During his time in industry he worked mainly for Glaxo (now GSK) in Quality Control, Quality Assurance and Analytical R&D positions. He has recently been appointed as Visiting Professor at the Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS) within the University of Strathclyde s Faculty of Science Dr Matthias Heuermann, LIGA.NRW, Münster, Germany Since 2004 Dr. Heuermann is director of the Official Medicines Control Laboratory (OMCL), Institute for Health and Work (LIGA.NRW) in Münster. He studied pharmacy and gained his PhD thesis at the University of Münster, Germany. Since 1995 Dr Heuermann has been GLP inspector and he is involved in national and international GMP inspections, mainly focused on QC laboratories and QA systems. Dr BOB McDOWALL, McDowall Consulting, Bromley, Kent, UK Analytical chemist with over 35 years experience including 18 years working in the pharmaceutical industry as a consultant. He is Principal of McDowall Consulting, UK. Bob is an ISO 17025 assessor and he has been involved with the validation of computerised systems for over 20 years and is the author of a book on the validation of chromatography data systems. Bob is also the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns and is a member of the Editorial Advisory Boards of several Journals. Dr. Bernd Renger Bernd Renger Consulting, Germany Dr Bernd Renger is a member of the ECA Advisory Board and Chairman of the European QP Association. Since 2011 he is running his own consultancy business. Before that he was Director of Quality Control at Vetter Pharma-Fertigung. He started his career at Hoechst AG as a research and development chemist. Since then, he has held several quality positions at Mundipharma, Altana Pharma and Baxter. ECA Education Course Lab Equipment Qualification, 12-14 October 2011 On 12 14 October 2011, i.e. from Wednesday to Friday of the same week, the ECA Education Course Lab Equipment Qualification will also take place in Amsterdam. Topics that will be covered are: Regulatory Aspects of Lab Equipment Qualification USP General Chapter <1058> - Analytical Instrument Qualification General Aspects of Calibration Risk Assessment in Analytical Laboratories Calibration Management (Case Study) Qualification of Spectroscopic Instruments and Detectors Qualification of GC Equipment Balances and Weighing Processes Case Study: ELISA Qualification Plate Readers Assurance of Controlled Temperature and Humidity General Aspects of Computer Validation in Analytical Laboratories HPLC / Chromatography Data Systems Integrated Qualification and Validation Validation of Excel Spreadsheets In addition, Workshops are offered about: Equipment List Case Study / Risk Categorisation According to USP <1058> Qualification / Risk Analysis of ph Measuring Equipment Balances Validation of Excel Spreadsheets Speakers: Dr. Christopher Burgess, Burgess Analytical Consultancy, UK Judith Kernbichler, Baxter Bioscience, Neuchatel, Switzerland Roland Miksche, Baxter Bioscience, Vienna, Austria The Pharmaceutical Laboratory Manager Conference (10-11 October 2011) is an ideal precursor to the Education Course Lab Equipment Qualification (12-14 October 2011). Further information about the Lab Equipment Qualification Course can be received at www.gmp-compliance.org. Participants who register simultaneously for both events will receive a 350 discount (not valid for EU GMP Inspectorates).

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, 10 October 2011, 9.00 h 18.15 h (Registration and coffee 8.30 h 9.00 h) Tuesday, 11 October 2011, 8.30 h 16.30 h Venue Mövenpick Hotel Amsterdam City Centre Piet Heinkade 11 1019 BR Amsterdam, The Netherlands Phone + 31 20 519 12 00 Fax + 31 20 519 12 49 Conference fees ECA Members EUR 1,490.- per delegate plus VAT APIC Members EUR 1,590.- per delegate plus VAT (does not include ECA Membership) Non-ECA Members EUR 1,690.- per delegate plus VAT EU GMP Inspectorates EUR 845.- 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. Would you like to save money? If you register for the Course Lab Equipment Qualification from 12 to 14 October 2011 at the same time, you will receive a 350 discount. This is not valid for EU GMP Inspectorates. Registration Via attached reservation form, by mail or by fax message. Or you register online at www.gmp-compliance.org. Accommodation CONCEPT has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the conference. Please use this form for your room reservation or be sure to mention VA 6945 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 29 August 2011. Early reservation is recommended. Conference language The official conference language will be English. Organisation and Contact CONCEPT HEIDELBERG P.O. Box 10 17 64 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 For questions regarding content: Dr. Günter Brendelberger (Operations Director) at +49-62 21/84 44 40, or per e-mail at brendelberger@concept-heidelberg.de. For questions regarding reservation, hotel, organisation etc.: Marion Grimm (Organisation Manager) at +49-62 21/84 44 18, or per e-mail at grimm@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) The Pharmaceutical Laboratory Manager 2011 10-11 October 2011, Amsterdam, The Netherlands +49 6221 84 44 34 I would also like to register for the ECA Education Course Lab Equipment Qualification, 12 14 October 2011, Amsterdam, The Netherlands * Mr * Ms Title, first name, surname Company CONCEPT HEIDELBERG P.O. Box 10 17 64 Fax +49 (0) 6221/84 44 34 69007 Heidelberg Germany Department Important: Please indicate your company s VAT ID Number Street / P.O. Box City Zip Code Purchase Order Number, if applicable Country Phone / Fax E-Mail (Please fill in) 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 %. 1 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)! wa/vers109030211