The Center for Professional Advancement, Burlingame, CA
March 17-19, 2008
Who Should Attend
This is an ideal course to acquire current applications of cGMPs. It offers latitude for discussion of fundamental as well as evolving regulatory initiatives and other complex issues. The course is distinguished for benefit to domestic as well as non-US enterprises, including the following:
Positions
Analysts, Directors, Engineers, Executives, Investigators, Internal Auditors, Managers, Operators, QA/QC, Research, Supervisors, and Trainers
Industries
Academia, Biogeneric, Biological, Biopharmaceutical, Combination Product Manufacturers, Consultants, Contract Manufacturing, Dietary Supplements, Health Care, Legal, All Pharmaceutical Aspects, Regulatory, and Many Others…Description
This course takes you through Current Good Manufacturing Practice (cGMP) in the pharmaceutical and allied industries. Topics covered include legal requirement for cGMP in the Federal Food, Drug, and Cosmetic Act and related regulations. It addresses practical aspects of personnel, facilities, equipment, components, manufacturing, laboratory, packaging, labeling and QA/QC and provides an excellent forum for training personnel in cGMPs. The faculty consists of individuals with long and distinguished experience in the field. Throughout this course, the relevance of FDA inspections commonly surfaces. There is special emphasis on discussing procedures and practices of the regulatory agency to help firms comprehend management of FDA relationships.
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Invited Speakers:
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Wayne A. Mazanec; Former FDA Asssistant Regional Director–Pacific Region, and Regulatory Consultant
Wayne A. Mazanec, M.S. retired from FDA after 33 years of progressive positions from Investigator, Supervisory Investigator, Investigations Director, and then to Assistant Regional Director for the Pacific Region. His career involved extensive operations in a broad range of commodity areas. His work also involved training of agents throughout the US for investigative work and complexities of epidemiology. Subsequent to retirement, he has consulted and trained industry in cGMPs, GLPs and GCP requirements and has provided recommendations and advisory assistance for manufacturing and research firms throughout the US and in non-US locations.
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