This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND).
Review and evaluate the most current Guidance for Industry 'CGMP for Phase I Investigational Drugs' effective dates of July 2008.This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials.
Review and evaluate the most current Guidance for Industry 'CGMP for Phase I Investigational Drugs' effective dates of July 2008.This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials.
Areas Covered in the Webinar:
- Introduction and background.
- Scope.
- Key elements.
- Who should comply with this document?
- Recommended CGMP elements for Phase I Investigational drugs.
- General guidance for complying with statute.
- Special manufacturing situations.
- Statutory and Regulatory Requirements.
Who Will Benefit:
This webinar will provide valuable assistance to all personal in:- Pharmaceutical
- Biotechnology industries
Course Provider
Jamie Jamshidi,
