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Introduction

With EU GMP & PICS Annex 1 for sterile product manufacturing substantially revised andbecoming effective there is a paradigm shift in GMP regulations that all are challenged with implementation With PICS Annex 1: Pharmaceutical Inspection Co- operation scheme involving 56 member countries, including the US FDA, this increases significantly the international significance of this new paradigm in GMP regulations.

The new GMP paradigm considers a Holistic, Risk-based (QRM), and proactive approach to contamination control and sterility assurance. This Training covers (15) Topics of high impact and includes a Discussion forum to bench mark with others and understand what is considered as required to meet CGMP Compliance. FDA 483s are now being issued with what is considered an Annex 1 mindset so highly relevant topics will be discussed.

Who Should Attend

Meet The Trainer

James, as ex-chairman (for 10 years) and honorary member of the PHSS: Pharmaceutical and Healthcare Science Society has followed Annex 1 revision to publication with a role played in the targeted revision process. The PHSS was appointed by the European Commission (EC) as one of the twelve (12) appointed commenting platforms in the Targeted consultation phase and James was Co-lead in commenting issued to the EC/ Annex 1 Inspectors Working Group (IWG) via the platform. James has also Co-Chaired an Annex 1 discussion forum in London following Annex 1 publication connecting stakeholders to regulatory authorities including MHRA, PICS members, Ex Annex 1 rapporteur, and Ex-MHRA GMP inspectors involved in commenting. 

James is a co-lead (together with Ex-MHRA Senior GMP inspector) of the PHSS Aseptic Processing and Annex 1 focus group and Contamination Control Strategy(CCS) Guidance initiative. In addition, James is currently the Head of GMP compliance for Franz Ziel GmbH the largest Barrier Technology (Isolator and RABS) and Cleanroom technology manufacturer in Germany. Project involvement includes filing lines (together with partners) for Pharma and ATMP product applications where increasingly aseptic processing applies

James L Drinkwater

Head of GMP Compliance at F Ziel
GmbH & ex-Chairman of PHSS - Head
of Aseptic processing group

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