Key areas that the FDA is likely to cover and what FDA’s expectations are This presentation will focus on those areas that the FDA is likely to cover and what FDA’s expectations are.
The pharmaceutical quality control laboratory, including process chemists, serves one of the most important functions in pharmaceutical production and control. A significant portion of the cGMP regulations (21 CFR 211) pertains to the quality control laboratory and product testing. Under the Food Drug and Cosmetic Act, FDA has a statutory obligation to perform a comprehensive GMP evaluation of each pharmaceutical quality control laboratory every two years. This presentation will focus on those areas that the FDA is likely to cover and what FDA’s expectations are.
The pharmaceutical quality control laboratory, including process chemists, serves one of the most important functions in pharmaceutical production and control. A significant portion of the cGMP regulations (21 CFR 211) pertains to the quality control laboratory and product testing. Under the Food Drug and Cosmetic Act, FDA has a statutory obligation to perform a comprehensive GMP evaluation of each pharmaceutical quality control laboratory every two years. This presentation will focus on those areas that the FDA is likely to cover and what FDA’s expectations are.
- What Attendees will Learn
- Areas that FDA Investigators are likely to cover and their expectaions of cGMPs for those areas.
- FDA’s Inspectional Approach
- Information Collection
- Laboratory Records and Documentation
- Out of Specifications (OOS) laboratory results
- Laboratory Control System and Standards
- Methods Validation
- Equipment and Laboratory Management
Who Will Benefit:
This webinar will provide valuable assistance to those persons who are associated with pharmaceutical quality control laboratories. The employees who will benefit include:- Analytical Chemists
- Microbiologists
- Quality Control Managers and Personnel
- production Employees
- Management
Course Provider
Sandra N. Whetstone,
