SeerPharma routinely deliver publicly scheduled courses in Australia, New Zealand and Singapore, with our flagship course GMP - What You Need To Know (SP6510) being one of the most sought after courses in our schedule.
This particular course steps through each chapter of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products Using case studies and examples drawn from industry and consulting experience, the course deals with GMP requirements and how they are applied to various manufacturing environment(s); with a focus on ensuring product quality and the prevention of adulteration and misbranding.
The course provides:
- An overview of the 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
- Workshops exploring common GMP problems and solutions
Having delivered this course recently, SeerPharma were honoured to receive the following testimonial from one of our attendees:
"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
Contact us if you’re interested in attending our next scheduled session, or if you’d like to attend any of our planned training courses which can be found at: https://www.seerpharma.com/services/qa-and-gmp-training/public