How to Survive an FDA Inspection

Omid Khodai OD, MS, RAC, CQA, CQM/OE, has more than 16 years of experience in Clinical, Medical, and Regulatory Affairs in senior management roles. He has coordinated all strategic and tactical aspects of regulatory submissions and clinical studies/trials according to standard operating procedures, study protocols, and domestic and international regulatory guidelines. Speaker has skillfully led the development and delivery of products across diverse therapeutic and diagnostic areas.

Prior to being a consultant, he served as Director of Clinical Research at Boston Scientific. In this role he led the clinical team to design and execute the company’s clinical trial strategy to produce a clinical evidence-base for regulatory, reimbursement, and commercial positions. He also served as Global Head of Clinical and Medical Affairs at STAAR Surgical, including successful approval of FDA Advisory Committee. He also served as Executive Director of Clinical and Medical Affairs and Scientific Communication at Bausch and Lomb where he successfully led the organization to approval of FDA Advisory Committee and commercialization of first of kind product as well as successful integration of a $5 Billion business through acquisition.