2011 - Full-day In-person Seminar - Key GMP Systems in Pharmaceutical and Biotech Labs

The FDA has ramped up surveillance and we have seen an increase in the number of warning letters issued to manufacturers. We have seen a corresponding increase in GMP upgrade projects in the industry.

This workshop will provide the audience with information to perform a gap analysis of their existing GMP systems by reviewing the major areas of concern listed by FDA inspectors. The systems covered will include FDA requirements for OOS Investigations, Pharmaceutical and Biologics Stability Programs and Method Validation.

This workshop will provide the audience with an overview of the key systems which have been mentioned by FDA Inspectors as major areas of concern in FDA Regulated Pharma Laboratories. During the discussion of each of the areas listed below, the Workshop participants will work through a series of related FDA 483s to fully understand FDA expectations and the errors which lead to the 483s.

Areas Covered:

1. FDA requirements for OOS Investigations

- Phases of an Investigation
- CAPAs, Investigation Conclusion and Documentation of the Investigation
- 483s related to OOS investigations and lessons learned from them

2. FDA requirements for Pharmaceutical and Biologics Stability Programs

- Overview of ICH and WHO requirements for Stability Programs
- Stability study requirements for Phase I, Phase II and Phase III clinical studies
- Stability methods and specifications
- 483s related to Stability Programs and lessons learned

3. FDA requirements for method validation

- Overview of relevant ICH guidances and USP <1226>
- Requirements for different method types
- 483s related to method validation and lessons learned