The FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs is a course that covers topics such as:
Scope
Background and rationale for guidance and proposed regulation
Recommendations for complying with the statue- personnel,Quality Control Function, facility and Equipment, Control of Components, Production and Documentation, Laboratory Controls,Container Closure and Labeling, Distribution and Record keeping
CGMP Statutory and Regulatory Requirements
Biological and Biotechnological Products
Special production situations
Sterile products/aseptically processed products
Past Events
FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs 2012 - 14 Feb 2012, Webinar (22216)
Important
Please, check "FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs" official website for possible changes, before making any traveling arrangements
