Key GMP Systems in Pharmaceutical and Biotech Labs (Biotech Training)

Venue: The Boston Park Plaza Hotel & Towers

Location: Boston, MASSACHUSETTS, United States

Event Date/Time: May 10, 2012 End Date/Time: May 11, 2012
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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 and Handling Regulatory Inspections.

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

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

2. FDA requirements for the equipment program
- Equipment Qualification
- Equipment operation and maintenance

3. 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

4. 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


50 Park Plaza at Arlington Street
United States