R. MICHAEL CROMPTON, J.D., MPH is a regulatory affairs professional with over 20 years of experience in the medical device industry. His employment has included roles as the Chief Compliance Officer and Vice President, Regulatory/Clinical Affairs & Quality Assurance at a large multi-national ophthalmic diagnostic and therapeutic medical device company, as well as vice president at two start-up medical device companies which developed and commercialized novel medical technologies in otolaryngology and interventional cardiology. His experience also includes tenure as an attorney at a leading Food and Drug law firm. He is a member of the Regulatory Affairs Professionals Society and the American Society for Quality. From 2000 to 2004, he served as the Industry Representative for the Ear, Nose and Throat Devices Panel of the FDA Medical Device Advisory Committee. He holds a bachelors degree in biochemistry and a masters degree in biomedical sciences from the University of California at Berkeley. He earned a doctorate in jurisprudence from the University of San Francisco School of Law and is a member of the State Bar of California.
The speaker will use current events in the industry to illustrate how regulatory compliance can significantly impact how a company operates. Current trends in the enforcement of FDA regulations and policy are discussed with a view towards maximizing success in achieving market authorizations and avoiding business interruptions in an increasingly challenging post-market environment. Companies can benefit significantly by incorporating an understanding and appreciation of regulatory processes into their business strategies.
How does the regulatory environment affect your job, your department, your product, and your company? What are the challenges you may face in a highly regulated environment? The speaker will help us understand and answer some of these questions by using examples from the industry
