FDA's Expectations for cGMPs for Analyst/Process Chemists

Instructor: Sandra N. Whetstone
Product ID: 700205

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Last Recorded Date: Sep-2007

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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.

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

Instructor Profile
Sandra N. Whetstone is a former (retired) US Food and Drug Administration (FDA) executive. She has more than 35 years of experience as a US Food and Drug official and is a recognized expert in US Food and Drug Law, the Public Health Service Act and related statues. Mrs. Whetstone is a co-founder and Managing Director of Comprehensive Compliance Solutions, LLC, a consulting company specializing in all aspects of FDA regulatory compliance matters relative to human and veterinary drugs, biologics, medical devices and foods. She has developed and presented cGMP training courses for Phase 1 and Phase II pharmaceutical manufacturers.

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