Programme. "Quality Control Laboratories: How to Inspect" PIC/S Pre- Seminar and Seminar
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1 PIC/S Pre- Seminar and Seminar "Quality Control Laboratories: How to Inspect" Programme Hosted by Taiwan Food and Drug Administration, Ministry of Health and Welfare September 2017 Grand Victoria Hotel No.168, Jingye 4th Rd., Zhongshan Dist., Taipei City, Taiwan
2 PRE- SEMINAR PROGRAMME Day 1 Monday, 11 September 2017 PIC/S Executive Bureau Meeting Venue: 3F, Noble III PIC/S Executive Bureau Lunch Venue: 2F, Xi Garden Restaurant PIC/S Committee Meeting Venue: 1F, Grand Ballroom 08:30 10:00 PIC/S Executive Bureau Meeting 10:00 10:30 Coffee Break 10:30 12:30 PIC/S Executive Bureau Meeting (continued) 12:30 14:00 PIC/S Executive Bureau Lunch 14:00 15:30 PIC/S Committee Meeting 15:30 16:00 Coffee Break 16:00 18:00 PIC/S Committee Meeting (continued) Day 2 Tuesday, 12 September 2017 PIC/S Committee Meeting Venue: 1F, Grand Ballroom PIC/S Committee Lunch Venue: 4F, No168 Prime Steak House PIC/S Seminar Welcome Reception Venue: 1F, Grand Ballroom 09:00 10:30 PIC/S Committee Meeting (continued) 10:30 11:00 Coffee Break 11:00 12:45 PIC/S Committee Meeting (continued) 12:45 14:00 PIC/S Committee Lunch 14:00 15:30 PIC/S Committee Meeting (continued) 15:30 16:00 Coffee Break 16:00 17:00 PIC/S Committee Meeting (continued) 18:00 20:00 PIC/S Seminar Welcome Reception and Registration 1/5
3 SEMINAR PROGRAMME Day 3 Wednesday, 13 September 2017 PIC/S Seminar Venue: 1F, Grand Ballroom PIC/S Seminar Lunch Venue: 3F, Victoria Ballroom 08:00 17:30 PIC/S Seminar Registration and Information Desk 09:00 09:30 A1 09:30 10:10 Welcome Address Representative of Taiwan FDA/MOHW PIC/S Seminar Opening Address PIC/S Chairperson Session 1: GMP inspection of Quality Control Laboratories Andreas Krassnigg Austrian Medicines and Medical Devices Agency (AGES) Current GMP requirements: Introduction of Revised Chapter 6 Quality Control of PIC/S GMP Guide Jacques Morénas Deputy Director French National Agency for Medicines and Health Products Safety (ANSM) A2 10:10 10:30 GMP Inspection of physical laboratories Expert Inspector Medicines and Healthcare products Regulatory Agency (MHRA) 10:30 11:00 Coffee Break A3 11:00 11: 30 A4 11:30 12:00 12:00 12:15 GMP Inspection of microbiological laboratories Expert Inspector Medicines and Healthcare products Regulatory Agency (MHRA) GMP Inspection of analytical laboratories Doreene Kohalmi Therapeutic Goods Administration (TGA) 12:15 13:30 Seminar Lunch 2/5
4 Parallel workshops W1 W2 13:30 15:00 Workshop 1- PIC/S Aide Memoire on inspection of Pharmaceutical Quality Control Laboratories: Discussion and input for revision Paul Gustafson Senior Corporate Regulatory Compliance and Enforcement Advisor Regulatory Operations and Regions Branch (RORB), Health Canada Yu- Chen Tai Taiwan Food and Drug Administration(TFDA), Ministry of Health and Welfare Workshop 2- Harmonising the Classification of Deficiencies of Quality Control Izabela Majić Head of Inspectorate Agency for Medicinal Products and Medical Devices of Croatia (HALMED) Doreene Kohalmi Therapeutic Goods Administration (TGA) W1 W2 15:00 15:30 Coffee Break 15:30 17:00 Workshop 1- PIC/S Aide Memoire on inspection of Pharmaceutical Quality Control Laboratories: Discussion and input for revision (continued) Evening at leisure Workshop 2- Harmonising the Classification of Deficiencies of Quality Control (continued) Day 4 Thursday, 14 September 201 PIC/S Seminar Venue: 1F, Grand Ballroom PIC/S Seminar Lunch Venue: 3F, Victoria Ballroom PIC/S Seminar Dinner Venue: 12F, Kunlun Hall, The Grand Hotel 08:00 18:00 PIC/S Seminar Registration and Information Desk Session 2: Specific issues of Quality Control Ger Jan van Ringen Dutch Health Care Inspectorate (IGZ) 3/5
5 B1 9:00-10:00 OOS/OOT Investigations Expectations & Commonly found deficiencies Lesley Graham Lead Senior Inpsector Medicines and Healthcare products Regulatory Agency (MHRA) Ileana Pettit Investigator 10:00 10:10 10:10 10:40 Coffee Break B2 10:40-11:20 B3 11:20-12:00 12:00 12:15 12:15 13:30 Seminar Lunch Data integrity in Quality Control: Industry perspective Charlie Wakeham Regional Informatics CSV Consultant at Waters; the chapter leader for GAMP Data Integrity Special Interest Group Data integrity in Quality Control: Inspector perspective Justin Boyd Investigator Parallel workshops W3 W4 13:30 15:00 Workshop 3 - Case study of Data integrity Justin Boyd Investigator Hiroshi Sakurai Pharmaceuticals and Medical Devices Agency (PMDA) Workshop 4 - Case study of OOS/OOT Investigation Mark Birse Head of Inspectorate Medicines and Healthcare products Regulatory Agency (MHRA) Lesley Graham Lead Senior Inpsector Medicines and Healthcare products Regulatory Agency (MHRA) 15:00 15:30 Coffee Break W3 W4 15:30 17:00 Workshop 3 - Case study of Data integrity (continued) Workshop 4 - Case study of OOS/OOT Investigation (continued) 17:30 Departure for Seminar Dinner 18:30 21:30 PIC/S Seminar Dinner 4/5
6 Day 5 Friday, 15 September 2017 PIC/S Seminar Venue: 1F, Grand Ballroom PIC/S Seminar Lunch Venue: 3F, Victoria Ballroom 08:00 13:30 PIC/S Seminar Information Desk Session 3: Workshop feedback Jacques Morénas French National Agency for Medicines and Health Products Safety (ANSM) Workshop 1 Workshop 2 C1 09:00 10:00 Workshop 3 Workshop 4 All facilitators 10:00 10:30 Coffee Break Session 4: Lifecycle Management of Analytical Procedures Jacques Morénas French National Agency for Medicines and Health Products Safety (ANSM) Test Methods Validation and Methods Verification in the context of a Technical Transfer: Industry perspective C2 10:30-10:55 Jennifer Cheung Genentech, Inc. C3 10:55-11:20 C4 11:20 11:45 11:45 12:00 12:00 12:15 12:15 12:30 12:30 13:30 Seminar Lunch Test Methods Validation and Methods Verification in the context of a Technical Transfer: Reviewer perspective I- Chen Sun Director, Division of Pharmaceutical Science, The Center for Drug Evaluation, Taiwan (CDE) Test Methods Validation and Methods Verification in the context of a Technical Transfer: Inspector perspective Azza Talaat 2018 Seminar Address Ellen Morrison Assistant Commissioner for Medical Products and Tobacco Operations, PIC/S Seminar Closing Address Representative of Taiwan FDA PIC/S Chairperson PIC/S Seminar close and depart 5/5
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