Course Introduction
The course provides an introduction to Good Manufacturing Practice for Investigational Medicinal Products and is made up of ten learning modules. The course covers the introduction and evolution of Good Manufacturing Practice (GMP) and gives an insight into understanding the basic principles of GMP within a research and development context, investigational medicinal products and qualified persons.
Course Key Points
The course includes:
- An understanding and appreciation of the history and context of GMP
- An understanding of why we need the GMP regulations and the basic underlying principles
- An appreciation of the scope and complexity of the GMP regulations and their content (at a high level)
- Where and how to find the various GMP regulations pertaining to investigational medicinal products within Europe and USAs' Code of Federal Regulations
- An understanding of which parts of the GMP regulations cannot be strictly applied to investigational medicinal products
- The relationship between the regulations and industry guidelines and best practices
- The role and responsibilities of the qualified person
Course Author
Paul E Last, Independent Consultant, is a former Chairman of both the RQA and of the RQA GMP Committee. He previously worked at Pfizer Global Research & Development (PGRD) as vice-president of the global supply chain responsible for the manufacture of active pharmaceutical ingredients and investigational medicinal products, IMP packaging, labelling and distribution. Previously he had various roles within PGRD including Director of QA (cGMP) and Manager of Analytical R&D. He has organised and presented at numerous cGMP training courses, GMP specialist meetings and international conferences.