How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

Duration: 90 Minutes
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.
How to Prepare for FDA Inspections
Instructor: Loren Gelber
Product ID: 504175
Objectives of the Presentation
  • 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.

Who will Benefit
  • Internal / External Auditors
  • Regulatory Management
  • Quality Assurance Professionals
  • Consultants
  • Sales/Marketing Management
  • Senior and mid-level Management
  • QA/QC
  • Compliance
  • Regulatory Affairs
  • Operations and Manufacturing
$200
Recorded Session for one participant
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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.
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