FDA's Expectations for cGMPs for Analyst/Process Chemists

Instructor: Sandra N. Whetstone
Product ID: 700205

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

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.

[*Refund Policy: No refund is offered for web-based events] [Computer System Requirements to View The Web Seminar/Test Your Computer]
Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
21 CFR Part 11 Compliance for SaaS/Cloud Applications - 80202SEM

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed