People responsible for pharmaceutical product quality and/or GMP compliance must be aware of their legal and ethical obligations.
You can only do this if you understand the regulatory environment along with the intent and requirements of Good Manufacturing Practices; a modern quality system as defined in PIC/S Guide to GMP.
This course will help by stepping you through each chapter and common appendix of version 13 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-13). 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.
- 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
- Workshops exploring common GMP problems and solutions
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 for a refresher, or existing companies that require a new GMP licence or GMP certificate from the TGA, Medsafe or HSA (e.g. 3rd party logistics providers that repack/reprocess).
Format and Course Length:
The 2-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
Call us or click here to e-mail us and register your interest in a public session or having this course delivered on-site.