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In this FDA inspection webinar attendees will learn the regulatory requirements for all FDA-regulated products. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. It will also highlight why the prudent firms needs to prepare them self for such inspections.


All manufacturers of FDA-regulated products, including drugs, foods, cosmetics, medical devices and veterinary products, are subject to the requirements to FDA inspection. This includes pre-Approval inspection for those products that require a specific submission to FDA, general GMP inspections and for cause inspections, such as those following complaints or recalls. The prudent firm will prepare itself for such inspections, using methods such as those to be discussed in this webinar. While this webinar will focus on pharmaceutical requirements, the concepts to be discussed will be applicable to all FDA regulated products.

This webinar will give employees concepts that they can apply to their particular firm in preparing for FDA inspections. It is prudent for all FDA-regulated firms to appoint a group of employees to prepare for FDA inspection. The members of this group require training in how to prepare for an FDA inspection. The consequences of a “failed” FDA inspection (one classified by FDA as OAI) can be quite severe.


  • General Information about FDA Inspections
  • Inspection Classification
  • Planning for Inspections
  • Self Audit Process


  • Practice or Mock Inspections
  • Corrections
  • Responding to inspectional observations
  • FDA Warning Letters and 483s (What not to do)


  • Quality
  • Regulatory Affairs
  • Manufacturing


Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has prepared more than 50 submissions to the FDA. Her specialty is compliance with US regulatory requirements. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.

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