Annual 4-Part Live Training Program – Instructors: Kim Huynh-Ba & Peter Calcott Ph.D.
Part 1: Facilities, Equipment and Manufacturing; Linking the Latest FDA , EMA and Other Regulatory Bodies’ Expectations With Respect to Design, Construction, Start Up and Commissioning of Facilities and Utilities and Operations to Best Practices
Part 2: Key GMP Requirements of Pharmaceutical Laboratories; Understanding the Latest FDA & Global Regulatory Requirements
Part 3: Pharmaceutical Raw Materials and Components Management Latest FDA, EMA and Canada Regulatory Requirements Including a Review of the EMA Falsified Medicines Directive, FDA Safety and Integrity Act, Drug Supply Chain Security Act, and Secure Supply Chain Pilot Program.
Part 4 : GMP Requirements for Records and Reports; Documenting Your GMP Activities and Understanding the Vital GMP Requirements of a Documentation System