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.
As of July 2022, the TGA in Australia adopts version 15 of the PE 009 PIC/S Guide to Good Manufacturing Practice for Medicinal Products (excluding Annexes 4, 5 and 14) as the manufacturing principles with legal force for:
- medicines and active pharmaceutical ingredients
- biologicals that comprise or contain live animal cells, tissues or organs
This course will help by stepping you through the key requirements of the PE 009-15 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 your manufacturing environment(s), with a focus on ensuring product quality and the prevention of contamination and adulteration.
Since May 2021, Medsafe in New Zealand has adopted version 14 of the PE 009 PIC/S Guide to GMP (excluding Annexes 3, 4, 5, 12, 16 and 18) as the standard for GMP audits of the manufacturing and packing of medicines. Only Annex 2 was revised between version 14 and 15 so this course is applicable to Medsafe-regulated GMP-licensed manufacturers.
- 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
"I found the GMP – What You Need to Know course an excellent investment in my educational development. The information was presented in a very user-friendly format and language – a sign of an experienced presenter and quality assurance professional. Of particular use were the comparisons between the previously and currently adopted PIC/S. The course notes are a very useful and quick reference guide. I would strongly recommend the course to anybody wanting a quick refresh or for those looking to enter into Quality Assurance".
Dr Gabrijela Matanović
Regulatory Affairs Manager, Apotex
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 needing training on current GMPs, 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.
This training has also been of value to organisations with an APVMA licence. Although the APVMA has its own code of GMP, the fundamental principles are aligned with the PIC/S Guide to GMP.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will be delivered as 2 full day sessions. Breaks are included.
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Each participant will attend both full-day sessions:
|Day 1||28th November 2023||9:00am-5:00pm|
|Day 2||29th November 2023||9:00am-5:00pm|
Times are based on Melbourne, Australia.
Fee and Discount
- AUD $1,400 (exc. GST) per participant
- A 10% discount applies for 3 or more participants from the same company
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Contact us to discuss your interest in a public or private delivery of this course.