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.
Areas Covered in the seminar:
- 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
Instructor Profile:
Jamie Jamshidi, CEO/President, has over 21 years of industry experience including Small Molecules and Biological/Protein products. She retired from Amgen Inc. after 17 years of service with the company. She has extensive knowledge and expertise in the areas of Quality Assurance, Manufacturing/Operations, Validations, Analytical Laboratories, Regulatory Submissions, Regulatory Inspections (PAI), Project Management, and Managing Contract Manufacturing sites, Technology Transfer, Management and Team Leadership including a broad understanding of the entire drug development process. She has extensive knowledge of FDA, EP, and JP regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives.
