Jeff Boatman is a Quality Systems Subject Matter Expert at QPharma, a regulatory and compliance consulting firm in Morristown, N.J. With 23 years in the medical device and pharmaceutical industries, Mr. Boatman has worked in virtually every aspect of life science engineering, from laboratory supervisor, manufacturing engineer, R&D, and quality and compliance management. He is a frequent speaker at industry conferences and was selected by PharmaVoice Magazine as one of 2010's "100 most influential people" in the drug industry. Mr. Boatman graduated from the College of the Air Force in 1981 with a degree in Nuclear Physics.
Nearly two years after releasing a draft validation guidance to replace their antiquated General Principles of Process Validation (1987), in January 2011 FDA finally published the official standard. Recorded