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Subscribe NewsletterGMP for Phase 1 Products
Product Id
:
W17
Overview: This presentation will cover the contents of the guidance that was given.
FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP.
FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP.
Areas Covered in the Session:
- What types of phase 1 products are covered by the rule, and which ones are not.
- What is the regulatory basis for the rule.
- 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 Will Benefit:
- Quality control and quality assurance workers.
- Regulatory Affairs personnel
- Product development workers
- Personnel planning clinical studies.
- Manufacturing supervisors