(FALL 2009)

A required course in the Certificate Programs in Medical Product Development, and Clinical Trials: Medical Device and Drug Development; and a prerequisite in the Specialized Studies Program in Regulatory Affairs Management.
This course presents a detailed overview of the regulatory requirements for the development and manufacture of pharmaceutical products. Individuals involved in manufacturing, quality control, research and development, and clinical studies will learn the latest information. Explore topics that include the product development process through commercialization; product characterization and pre-clinical evaluation; clinical trial requirements, good manufacturing practices (GMPs); good laboratory practices (GLPs); regulatory compliance inspections, labeling and advertising of medical products; and preparing regultory submissions. Approved for 27 hours of general MCLE credit for eligible participants.

Yasamin Ameri, M.S., RAC, principal consultant, Quest International Consulting Incubator LLC, has over 18 years experience in the life science industry. Ameri has reviewed and set up quality systems for drug and device companies, and reviewed CMC sections, NDA and IND supporting documents prior to submitting to the FDA. She has trained auditors to audit medical device companies per ISO 13485 requirements.