SP6510: GMP – What You Need To Know According To PIC/S Guide To GMP Version 14 (PE 009-14)

Date posted: 22 June 2020

Event date: 20 and 21 July 2020

If you’re responsible for any part of pharmaceutical product quality or 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 current Good Manufacturing Practices as defined by PIC/S.

Australia’s Therapeutic Goods Administration (TGA) will be adopting version 14 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-14) for medicines, Active Pharmaceutical Ingredients (APIs) and sunscreens commencing on the 1st July 2020. In the announcement, the TGA stated that “manufacturers are encouraged to commence preparations … in anticipation of the adoption of the PIC/S Guide to GMP PE009-14.”

To support TGA-regulated organisations, SeerPharma has updated its GMP – What You Need to Know training course to address the current PIC/S GMP Guide (PE 009-14). This course will help by stepping you through each chapter and common appendix of version 14 of the PIC/S Guide to GMP for Medicinal Products Part I, including the key changes from version 13. Using case studies and examples drawn from industry and consulting experience, you will learn the requirements and how they are applied to your manufacturing environment(s), with a focus on ensuring product quality and the prevention of adulteration and misbranding.

Content
  • An overview of the Australian regulatory environment
  • GMP Basics: Personnel and Training, Equipment and Facilities, Production and Packaging Controls, Process 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
  • Key changes in the PIC/S Guide to GMP Part I (PE 009) from version 13 to version 14
    • Chapter 3 – Premises and Equipment
    • Chapter 5 – Production
    • Chapter 8 – Complaints and Product Recall
    • Annex 17 – Real Time Release Testing and Parametric Release
  • Workshops exploring common GMP problems and solutions
Participants

This course has been designed to provide personnel new to the pharmaceutical industry with a good understanding of PIC/S GMP and Pharmaceutical Quality System requirements. It also applies to experienced GMP staff looking to update to comply with current PIC/S GMPs (PE 009-14), or existing companies that require a new GMP licence or GMP certificate from the TGA or Medsafe; including 3rd party logistics (3PL) providers that repack/reprocess medicines.

Format and Course Length

The course will be delivered as an online virtual-classroom training session.

Sessions

Each participant will attend both full-day sessions:

 Sessions  Dates  Times
 Day 1  20th July 2020  8:30am join for 9:00am-5:00pm
 Day 2  21st July 2020  8:45am join for 9:00am-5:00pm

Times are based on Melbourne, Sydney and Brisbane; Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00

Fee and Discount
  • AUD $1,200 (exc. GST) per participant
    • A 10% discount applies for 3 or more participants from the same company

Find out more and register now. 

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