This online course provides the background for the origins of the ICH guidelines, Q8(R2), Q9, Q10 and Q11. It covers development and manufacture of drug substances (chemical entities and biotechnological/biological entities) and the link between these and other relevant regulatory guidelines and the ISPE PQLI Guides. At the conclusion of this session, participants will have knowledge of:
- Discuss the key concepts of the industry's history and vision.
- Describe the Vision, Purpose, and goals of PQLI.
- Identify potential benefits of PQLI.
- Discuss the Key Elements of the Product Realization Guides.
- Describe the importance of the Product Realization Guides.
Attendance suggested for:
- Years in industry: 0-4 to 5-14
- Manufacturing, engineering, quality and validation professionals with intermediate level experience in manufacturing, engineering, validation, quality control and assurance, technology transfer and those that are new to Quality by Design principles.
Chris Potter graduated from the University of Exeter with a degree in chemistry and completed a PhD at Imperial College London University in organic chemistry. He started work at Beecham Research Laboratories, and moved to Sterling-Winthrop to take management positions in both pharmaceutical and analytical development. During this period he worked on both ethical and over-the-counter drug development. For the later period of his career, Potter moved to ICI Pharmaceuticals, later Zeneca, then AstraZeneca where he had a senior positions as manager of Analytical Development and R&D QA and CMC Project Management Group with responsibility in both the UK and US. He finished is career as Director of External Pharmaceutical Programmes. Potter retired at the end of October 2007 and is now performing part-time CMC consultancy work. He is currently part time Technical Project Manager for ISPE's PQLI Program. Potter was a member of EFPIA's ad hoc Quality Group from 1996 to 2007, and during this period was EFPIA topic leader for ICHQ6A, Specifications for New Drug Substances and New Drug Products, and ICH Q4B, Regulatory Acceptance of Pharmacopoeial Interchangeability. Potter led EFPIA's PAT Topic Group, which produced a Mock P2 to promote discussion and understanding regarding how ICH topics Q8 and ICH Q9 could be implemented.