Free on-demand webinar

CGMP & Quality Management for OTC Manufacturers

6 Critical Compliance Questions in Areas of Regulatory Focus

45-minute presentation with 15-minute Q&A.

The FDA has stepped up inspections of manufacturing facilities producing over-the-counter (OTC) drugs and similar health products following a number of repeatedly observed current good manufacturing practice (CGMP) deficiencies.

This has resulted in multiple warning letters, import alerts, and recalls.

Most of these issues demonstrate fundamental problems related to the quality management system (QMS).

Watch this free recorded webinar and learn the six key questions for assessing CGMP compliance and quality management related to the issues being observed in OTC manufacturing facilities.

What you'll receive in this presentation:

  • A brief overview of the six common themes of noncompliance at OTC facilities
  • Expert analysis into warning letter excerpts and sample questions firms should ask when assessing necessary remediation efforts
  • Firsthand examples of issues observed during CGMP audits in the field
  • An overview of relevant regulations and standards
  • An opportunity to get questions answered by our panelists
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