GMP Expectations for Products Used in Early Phase IND Studies 2018

Key Topics

• What to do at really early stages
• Discussion of the elements found in the guidance document for Phase 1 material
• What about preclinical studies?
• What about special IND studies?
• What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
• Varying GMP activities that depend upon the nature of the IND product
• What to do about QC activities such as instrument qualification, method validation, and process validation

Who should Attend

• QA/QC Personnel who Need to Plan Work on Early Stage Material
• Regulatory Affairs Personnel who Coordinate Activities for the CMC Sections of Submissions
• Project Managers for Product Development Studies
• R & D Personnel who Will Contribute data to CMC Sections
• Consultants
• Quality Systems Auditors