Join this webinar by expert speaker Robert Russell who will provide you with an opportunity to understand the requirements of ICH GMP comprehensively. You will learn about the nuances and differences between the three main triumvirate regions of ICH—US, EU and Japan.
The session will cover the key areas of establishment of ICH, the objectives and goals, expectations of the healthcare authorities involved, and the practical differences which you would experience in inspection of a GMP facility by FDA, which is PMDA’s EU competent authority.
Who Should Attend
This Webinar will provide invaluable assistance to all license owner personnel in the pharmaceutical, biotechnology and combination products areas, including contract manufacturers, packagers and suppliers. Particular functional expertise receiving value from attending would be:
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Dr. Jerry Lanese,
- Jennifer Diaz,
- Norma Skolnik,
- Dr. David Lim, Ph.D., RAC, ASQ-CQA
- Paul Lorcheim, P.E.
- Ginette Collazo, Ph.D.
Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.