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 Guide, 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:
- Method Validation
- Out of Specification Results
- Validation of Excel Spreadsheets
- Method Transfer
The course will also discuss the implication of new developments resulting from recent FDA and USP initiatives, such as analytical lifecycle management with continuous monitoring, data integrity, ...