FDA Inspection Intelligence - Webinar Recording/Transcript

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FDA Inspection Intelligence: New Focus on Data Integrity and cGMP Compliance

Drug and biologics makers are facing increased scrutiny of data integrity as an energized FDA deploys new tools to empower inspectors and concerns rise over Forms 483 and warning letters.

Mark I. Schwartz Esq. has seen it from the inside as former Deputy Director of OCBQ, CBER. Now in private practice, he advises clients like you on staying a step ahead of inspectors. Mark will spend 90 minutes mapping this new FDA crackdown, with fresh details on:

  • Background: Why the FDA is stepping up pursuit of data integrity issues now
  • The product adulteration threat: How FDA may invoke the FDASIA provision when companies balk at inspections
  • Sec. 704(a)(4): Why the agency may invoke this provision regarding advance request of records or in lieu of an inspection
  • The draft Quality Metrics initiative: Where it stands
  • And much more!

Here’s a rare chance to spend 90 minutes with an ex-insider still intimately involved with CBER inspections as a lawyer in private practice, and not pay a penny in sky-high hourly legal fees. So don’t delay.

This session is appropriate for anyone concerned with quality and inspections at pharmaceutical and biologics facilities, including:

  • QA/QC
  • Regulatory/compliance
  • cGMP/manufacturing
  • Data analysis
  • Legal counsel

Mark I. Schwartz Esq., Director, Hyman, Phelps & McNamara, is the former Deputy Director of OCBQ, CBER. In a 13-year FDA career, Mr. Schwartz also worked closely CBER’s Division of Manufacturing and Product Quality and Division of Biological Standards and Quality Control, and served as Associate Chief Counsel of the FDA. Now in private practice, he advises clients on drug, biologic and device compliance, chemistry, manufacturing and control, and combination products, and has served as an expert witness in FDA-related litigation.