Topics
- What is the regulatory basis for the rule
- What types of phase 1 products are covered by the rule, and which ones are not
- A description of what is considered to be the GMP under the Food, Drug, and Cosmetic Act, and how it compares to the GMP given in 21 CFR 211
Who should Attend
Regulatory Affairs personnel, Quality control and quality assurance workers, Personnel planning clinical studies, Product development workers and Manufacturing supervisors.
