The purpose of this three-day education course is to give participants a comprehensive overview of FDA’s current compliance requirements (21 CFR Part 211, Guidances for Industry, Compliance Program Manual, etc.) and expectation in these and related areas, and how they can be managed effectively.
The format allows each of our speakers to give an overview of the specific regulatory requirements associated with their topic prior to describing the approach to managing the issues with respect to philosophy, documented procedures, SOPs, etc.
In addition, the programme includes four workshop sessions covering:
Out of Specification Results
Validation of Excel Spreadsheets
The course will also discuss the implication of new developments resulting from recent FDA initiatives.
For more information visit gmp-compliance.org