How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

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.

Why You Should 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.

Areas Covered in the Session :

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

  • 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

FDB2959

Dr. Loren Gelber

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 then transitioned 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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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance