GMP – What You Need to Know

Starts:  Mon, Oct 12, 2026 09:00 AM (Melbourne time)
Ends:  Tue, Oct 13, 2026 05:00 PM (Melbourne time)
Associated with  National Space
If you're responsible for any part of pharmaceutical product quality or Good Manufacturing Practice (GMP) compliance, you must understand your legal and ethical obligations.  To understand your obligations, you must understand the regulatory environment as well as the intent and requirements of a Pharmaceutical Quality System and GMP.
 
This course will help by stepping you through the key requirements of the PE 009 PIC/S Guide to GMP Part I. Using case studies and examples drawn from industry and consulting experience, you will learn the GMP rules and how they are applied to manufacturing environments, with a focus on ensuring product quality and the prevention of contamination and adulteration.

Content

  • An overview of the Australian (TGA) and New Zealand (Medsafe) regulatory environments
  • GMP Basics: Personnel and Training, Equipment and Facilities, Production and Packaging Controls, Validation, Quality Control, Out of Specification, Stability Programs
  • Good documentation and record keeping practices
  • Quality Management Basics: a Quality Systems approach to GMP, Quality Risk Management, Managing Changes and Deviations, Product Quality Reviews
  • Workshops exploring common GMP problems and solutions
More information
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Location

Online Instructions:
Url: https://www.seerpharma.com/services/qa-and-gmp-training/sp6510-gmp-what-you-need-to-know
Login: Zoom meeting details provided after registration.

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