FDA Inspection Preparation

Loren Gelber

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Description of the topic:

This webinar will include things that it is important to know about FDA inspections.Using the self-auditing process to correct problems before the FDA or customer arrives will be discussed.How to prepare for an FDA inspection and how to behave during one will be reviewed.The usefulness of mock inspections and other practice routines will be considered.How to respond to FDA inspectional observations (FDA form 483) and customer observations will also be discussed.The FDA definitions of inspection classifications, and their real life consequences, will be presented.How to avoid FDA Warning Letters, and when it is possible to do so, will be reviewed.


Pharmaceutical, medical device and dietary supplement manufacturers are subject to inspections by the FDA.

Why should you attend?

All pharmaceutical firms, whether Over-the-Counter or Prescription, as well as medical device or dietary supplement firms, are subject  to FDA inspections as soon as they submit a drug or device listing, an application for a new or generic drug or device, or introduce a drug, device or dietary supplement into interstate commerce.  Customers, such as chain drug stores, are also likely to audit a new firm before buying anything from them and periodically thereafter.  If a firm has a process in place for self-auditing, inspection planning and practice, they are more likely to have a successful FDA inspection or customer audit.

Areas Covered in the Session :

  • General  Information about FDA Inspections
  • Self Audit Process
  • Planning for Inspections and Audits
  • Practice or Mock Inspections
  • CGMPs
  • Responding to inspectional observations
  • Avoiding FDA Warning Letters


Who will benefit: 

Quality Personnel, Regulatory Affairs and anyone who will be on an inspection or audit team, Sales and Marketing

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Loren Gelber, Regulatory Compliance Consultant (Ex-FDA Official)

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She participated in the development of method validation requirements for HPLC analytical methods. She then transitions to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.

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