Training sessions: “Non Sterile and Sterile products regulation and guidance – An update on the requirements, issues and opportunities” will be held in:

Perth: February 11 & 12
Sydney: February 15 & 16
Melbourne: February 18 & 19

During these two day courses Gordon will cover the compliance aspects of:

• EU/PIC-S Annex 1 Essentials
• USFDA guidance versus the EU/PIC-S guidance and the key differences
• How ISO 14644-1 &2 apply to the context of sterile GMPs
• Status of PIC-S PI032-11 Dec 2009, “Recommendation – GMP Annex1 Revision 2008, interpretation of the most important changes for the manufacture of sterile medicinal products”
• Workshop sessions to reinforce and provide the opportunity to apply what you learn in a practical context
• Of course, your questions answered.

Gordon’s core skills and experience encompass chemical & biological APIs, and all dosage forms, including device/drug combination products.

Gordon is active in developing standards and guidance in our industry. He is Chair of British, CEN and ISO committees responsible for development and deployment of the ISO 14644 family of cleanroom standards, and is an Advisor to the EMEA concerning the revision to Annex 1 of the EU GMP in February 2008.

Gordon is a Member of the WHO expert committee (WHO Pharmaceutical Water GMP; Sterile GMP Annex 1).

How to book

Go to: http://www.pharmout.com.au/training_gordon.html to book places.

Bookings close on Feb 5th 2010.