This chapter is taken from the book Pharmaceutical Outsourcing: Quality Management and Project Delivery
Written by a subject matter expert, here is best-practice guidance that describes what to think about and how to implement those ideas as a company sets about creating a useful, effective Quality Agreement.
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Format: PDF (1 file 199 KB)
About the Author
Ken Drost has been in the pharmaceutical industry since 1979 and has experience in various capacities including Process Development, Manufacturing and Quality. He spent 20 years at Hoffmann La Roche both in NJ and Basel Switzerland, five years as a Senior Consultant at KMI/Parexel (now Parexel Consulting) and has been at Amgen for almost 10 years.
He currently leads the Amgen Contract Manufacturing organization and recently led the North America Quality organization, which included External Quality and the Amgen North America manufacturing sites. He has a B.S. and M.S. in Biology from Fairleigh Dickinson University in New Jersey.