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How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

Thursday, 24 January 2019  11:30 AM PST, 02:30 PM EST

Training Duration = 90 Minutes                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

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. How to avoid FDA Warning Letters, and when it is possible to do so, will be reviewed.

Learning Objectives:

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

Why Should You Attend:

All pharmaceutical firms, whether Over-the-Counter or Prescription, are subject to FDA inspections as soon as they submit a drug listing, an application for a new or generic drug, or introduce a drug 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.

Instructor Profile:

Dr. Loren Gelber is currently an independent consultant, based in Charlotte, NC.She previously was employed by Akesis, Bestsweet, RRI, Andrx, Royce, Universal Research, Danbury Pharmacal, Barr and the US FDA. She has been in Regulatory Compliance, Regulatory Affairs, Clinical Research and Quality Control Laboratories.

Dr. Gelber has a Ph.D. in Medicinal Chemistry from Northeastern University, a Masters in Chemistry from Brooklyn Polytechnic and a Bachelors in Biology from Brandeis University.