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Heath Coats
Principal Consultant at Parexel

Profile

Heath has over 25 years of industry and consulting experience in parenterals and biologics. Prior to joining Parexel, he was a Biologist with the Division of Manufacturing and Product Quality (DMPQ) in FDA’s CBER, reviewing applications and supplements for cell therapy products, HPC cord blood, plasma fractionated products, vaccines, allergenics, and in vitro diagnostics. Heath gained his managerial experience at a cell therapy contract manufacturing company and has extensive expertise in pre-license and pre-approval inspections, as well as hands on technical skills of the design, operations, and compliance of manufacturing facilities.

Agenda Sessions

  • Current Good Manufacturing Practices (CGMP) Compliance Issues for Gene Therapy Products

    On Demand