GMP Expectations for Products Used in Early Phase IND Studies 2018 is a webinar that covers topics such as:
- 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
GMP Expectations for Products Used in Early Phase IND Studies 2018 is intended for:
- 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