Seminars

Seminars are hosted each year by a different PIC/S Participating Authority. Each Seminar focuses on a particular aspect of GMP with the aim of providing training and harmonisation in the field covered. Annual PIC/S training Seminars are open to Inspectors from PIC/S Participating Authorities and other interested Medicine Regulatory Authorities. Seminars are not open to Industry

2017 Seminar on "Quality Control Laboratories"   

The Taiwan Food and Drug Administration (TFDA), Chinese Taipei will be hosting the 2017 PIC/S Seminar on "Quality Control Laboratories" in Taipei (Chinese Taipei) from 11-15 September 2017.

The Seminar will be on " Quality Control Laboratories: How to Inspect " and consist in a mix of presentations and workshops.

Quality control is part of Good Manufacturing Practice for ensuring the safety, quality and efficacy of pharmaceutical products. Thus, the quality control laboratory plays an integral role in confirming the quality of medicinal products. Through the seminar, participants will be introduced to basic concepts, current and trending regulatory requirements, as well as specific quality issues which have impacted on the regulatory compliance of Quality Control Laboratories. The program will include topics related to GMP inspections on QC lab and will delve into OOS/OOT investigation, data integrity issues and aspects of test methods validation and verification in the context of technical transfer. The seminar will also be a great platform for both novice and experienced inspectors to enhance their inspection skills through knowledge sharing and discussion.

For more information: click here


Key Features of Seminars

PIC/S Seminars last for 2.5 days and are attended on average by more than 100 participants from over 46 countries. All participants must pay for their own costs (registration fee & accommodation).

Seminars are not profit-oriented. They are organised by Regulatory Authorities for Regulatory Authorities in line with the PIC/S Aide-Memoire on Organisation of Seminars. Industry cannot attend as such PIC/S Seminars except as invited speakers. Most presentations are given by active Inspectors while only a few are given by speakers from other fora (university, organisations, industry, etc.). 

The outcome of Seminars usually results in the formation of a working group to develop a draft Guidance or Recommendation. For example, the 2004 Seminar on Active Pharmaceutical Ingredients (APIs) resulted in the preparation and the issuing of the PIC/S Aide-Memoire on the inspection of APIs.


Past Seminars

PIC/S Participating Authorities have hosted Seminars since 1971. The following list offers an overview of Seminar topics and hosts over the years.

Year

Topic

Host

2015  Biopharmaceuticals (Biotechnology and Biologicals): How to Inspect Nusa Dua | Indonesia
2014 Dedicated Facilities: Yes or No Paris | France
2013 Global Supply Chains and GMP Compliance Ottawa | Canada
2012 Qualification and Validation: Today and Tomorrow Kiev | Ukraine
2011 Good Pharmaceutical Inspection Practices Cape Town | South Africa
2010 GMP Inspection of Manufacturers of Traditional / Herbal Medicinal Products Kuala Lumpur | Malaysia
2009 Inspection of Aseptic & Sterile Manufacturing from APIs to finished dosage forms Uppsala | Sweden
2008 Good Distribution Practices Krakow | Poland
2007 The Inspection of the Manufacture of Solid Dosage Forms Singapore | Singapore
2006 Quality Risk Management and related ICH topics  Düsseldorf | Germany
2005 Primary packaging material, labelling and the prevention of mix-ups (including counterfeit packaging and labelling) Bucharest | Romania
2004 The Inspection of Manufacturers of Active Pharmaceutical Ingredients Barcelona | Spain
2003 The Inspection of Quality Control Laboratories Bratislava | Slovak Republic
2002 The Interface Between Good Clinical Practice (GCP) and GMP in the Manufacture and Audit of Clinical Trial Products Montebello, QC | Canada
2001 Utilities Used by the Manufacturer of Pharmaceuticals Prague | Czech Republic
2000 The Inspection of Products derived from Biotechnologies Colmar | France
1999 Non-Technical Aspects of Inspection Oxford | United Kingdom
1998 Quality Systems for Pharmaceutical Inspectorates Zeist | Netherlands
1997 Manufacture and Inspection of Active Pharmaceutical Ingredients Naantali | Finland
1996 GMP Standards for Active Pharmaceutical Ingredients Canberra | Australia
1996 Inspection of Computer Systems Sydney | Australia
1995 Inspecting the Manufacture of Sterile Products - Current and Future Trends Hveragerði | Iceland
1994 Qualification and Validation in Pharmaceutical Manufacture Dublin | Ireland
1993 The Role of Inspection and Testing in relation to the Marketing Authorisation Louvain-la-Neuve | Belgium
1992 New Aspects of Products Derived from Biotechnology Montecatini Terme | Italy
1991 Audit - Pharmaceutical Inspection Felsötárkány | Hungary
1990 Blood and Blood Products Hillerød | Denmark
1989 Contamination Risks in the Manufacture of Parenterals Baden | Austria
1988 Water for Pharmaceutical Purposes Jongny | Switzerland
1987 The Business of Pharmaceutical Inspection Cambridge | United Kingdom
1986 Plastics and their Pharmaceutical Applications Sigtuna | Sweden
1985 Premises for Pharmaceutical Manufacture Oslo | Norway
1984 Requirements of Good Manufacturing Practice and Quality Control in the Production of Biological Products Frankfurt a/Main | Germany
1983 Safety Aspects of the Packaging of Pharmaceutical Products Lisbon | Portugal
1982 Validation Dublin | Ireland
1981 Application of GMP Rules in the Control Laboratory Budapest | Hungary
1980 Good manufacturing Practice in the Manufacture of Active Ingredients Liestal/Basel | Switzerland
1980 Inspection in Tablet Manufacture Copenhagen | Denmark
1979 PIC Basic Standards of GMP - Need for Revision? Helsinki | Finland
1978 Large Volume Parenterals Oslo | Norway
1978 Good Manufacturing Practice in Tablet Manufacture Sunnindale | United Kingdom
1977 Modern Methodology for the Isolation, Identification and Quantification of Drugs and Related Substances Uppsala | Sweden
1976 Stability of Pharmaceutical Products Salzburg | Austria
1975 The Manufacturer's Quality Control Department Structural and Functional Aspects Copenhagen | Denmark
1974 Manufacture and Quality Control under Contract Berne | Switzerland
1973 Sampling and Analytical Control Edinburgh | United Kingdom
1972 The Quality of Pharmaceutical Products Rennes | France
1972 Contamination in the Manufacture of Pharmaceutical Products Stockholm | Sweden
1971 Safety Aspects Involved in the Packaging and Labelling of Pharmaceutical Products Geneva | Switzerland





Training Materials

All Seminar training materials are available under Materials. Login is required.