Stephen P. Westover Cook MyoSite Incorporated
Stephen Westover is the Director of Regulatory Affairs at Cook MyoSite Incorporated, where he is the point of contact with health authorities for the clinical investigation and eventual commercial licensing of cellular therapy products and oversees the regulatory interactions and submissions to health authorities including the Food and Drug Administration (FDA), Health Canada, and European competent authorities.
Stephen started his career with manufacture of influenza vaccine at Wyeth Pharmaceuticals. At Cook MyoSite, he has directed the development of a pharmaceutical quality management system, quality control testing laboratory, and validation activities. Stephen has led compliance efforts in Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). Stephen is a certified manager of quality and operational excellence through the American Society of Quality (ASQ) and is certified in RAC Drugs through the Regulatory Affairs Professionals Society (RAPS). Stephen is using his quality experiences to balance the liabilities of commitments in regulatory submissions with actions of the pharmaceutical quality management system.
Stephen started his career with manufacture of influenza vaccine at Wyeth Pharmaceuticals. At Cook MyoSite, he has directed the development of a pharmaceutical quality management system, quality control testing laboratory, and validation activities. Stephen has led compliance efforts in Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). Stephen is a certified manager of quality and operational excellence through the American Society of Quality (ASQ) and is certified in RAC Drugs through the Regulatory Affairs Professionals Society (RAPS). Stephen is using his quality experiences to balance the liabilities of commitments in regulatory submissions with actions of the pharmaceutical quality management system.