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REGULATIONS AND GOOD MANUFACTURING PRACTICES IN BIOTECHNOLOGIES
This certification provides a comprehensive review of the role of regulation in biopharmaceutical technology products and services development and commercialization. The certification covers in general the current regulations that applied to Puerto Rico and USA including overview of OSHA, PROSHA and EPA/EQB with major focus on FDA rules and regulations. Certification emphasis will be in and Good Manufacturing Practices (cGMP’s), quality awareness, record integrity, documentation, 483’s, business impact in dollars and jobs. Safety, recall cases, liabilities and basic in auditing.