How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals
Product Code: : PMAQ-9279
Speaker : Dr. Loren Gelber
Date : 11th June 2019
Time : 11:30 AM PST | 02:30 PM EST
Duration : 90Min

Overview:

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 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. 

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 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

Speaker Profile:

Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous FDA Inspections.  Her specialty is in 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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