FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs 2012

February 14, 2012(Ended)
Online Webinar
FDA’s Current Thinking for Industry cGMPs for Phase 1 INDs 2012

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
Prices *
249-999 US Dollar
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* Prices are for evaluation only.