International GMP best practices are based on the latest PIC/S Guide to GMP for Medicinal Products version 14 (PE 009-14). TGA GMP inspectors have been using version 14 for GMP inspections since 1 July 2020.
There are some major changes from the PIC/S GMP Guide version 13 (PE 009-13) that organisations need to address to maintain compliance. This training course is designed to help you understand the changes and what you need to do meet the new GMP requirements.
The course will focus on:
- Starting Materials (Chapter 5) - This section has been significantly strengthened, with greater onus on the manufacturer to have an improved knowledge and greater control of their starting material suppliers.
- Cross Contamination (Chapters 3 and 5) - The changes for preventing cross-contamination in production are significant and require more focus.
- Product Shortages (Chapter 5) - Shortages in product supply (now or future) to be reported in a timely manner to marketing authorisation holder and relevant authorities.
- Complaints and Recalls (Chapter 8) - Significant update with virtually double the number of clauses.
- Real Time Release Testing and Parametric Release (Annex 17) - Significant changes with 10 new clauses
This course has been designed for senior staff in pharmaceutical manufacturing organisations to understand how the changes affect their organisation as well as their business unit’s responsibilities and interactions with other units.
You may be a Production Manager, QA Manager, QA Supervisor, QC Manager, IT Manager, Validation Manager etc.
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 x 3.5 hour sessions over 2 days. Each session will include a break.
PDF Certificates will be provided to participants electronically.
Contact us to discuss your interest in a public or private delivery of this course online or on-site.