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Identifying and Preventing the Most Common Drug and Device cGMP Issues

The FDA is under intense pressure to ramp up inspections and enforcement activity following a slowdown throughout the pandemic. Are you ready?

Grab our expert guide and answer that question confidently.

Experienced auditor and Quality/Regulatory consultant Neal Siegel:

  • Identifies the top-cited drug and device cGMP issues over the past few years
  • Provides firsthand observations on how these issues arise in manufacturing organizations
  • Delivers best practices for detecting, addressing, and preventing these issues—ensuring full compliance and readiness for inspection

You'll come away with practical knowledge into the issues FDA finds and cites most often along with expert takeaways you can apply within your organization to strengthen your systems and be fully prepared for a new wave of inspections.

This guide offers valuable insights for all professional levels in the regulated life science industries—from company and functional leadership to frontline technicians and specialists.

About the Contributor

Neal Siegel is an industry Quality/Regulatory consultant (IVD/Med Device/Pharma) with 25+ years of experience and a particular interest in quality statistics and their understandable, practical application in instances of compliance shortcomings. He has extensive, successful experience from lab bench to C-suite and welcomes opportunities to mentor and teach sustainable skills for the industry. Neal has participated in assessment and remediation teams for companies with severe Warning Letters and Consent Decrees and is knowledgeable in successful recovery from these types of regulatory actions. 

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