Delaying, Denying, Limiting, Refusing Inspections
What’s In The FDA Investigator’s New Handbook

The recent FDA guidance titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing to Permit Drug Inspection” has quickly become a hot button.

• Is it overreaching?  Some in industry have called it a “power grab.”
• It’s rooted in legislation aimed at drug makers, but does it apply to device makers too?
• If your inspection handling SOPs say no photographs, are you really “limiting” an investigator if you say put the camera away?
• While not found in the FD&C Act, FDA believes it has the right to interview any employee.  Can that be justified?
• FDA now says it can demand production of records maintained in facilities other than the one actually being inspected.  Can you accommodate that request?
• Plus, many have been scratching their heads about how to interpret words like “reasonable”, “timely” and “without adequate justification.”  So, where do you bend and where do you stand firm?

What does all this mean for you? First, and foremost, every FDA-regulated industry must become deeply familiar with the guidance.

Second, companies need to take an in-depth review of their inspection handling procedures and SOPs and see where they are in conflict with the FDA’s new positions.

To help manufacturers better understand the final guidance, FDAnews has engaged FDA inspections expert and attorney Lynn C. Tyler to lead a 90-minute webinar on the subject on December 16. He will discuss how inspections might change based on the guidance and also present strategies on how to interact with the FDA regarding inspections since the guidance appears to give the agency increased authority. 

Attend this session and you'll learn:

• Four specific ways in which the new guidance seeks to increase FDA’s inspection powers
  
• Legal and operational strategies for responding to FDA’s assertion of increased authority
  
• How the FDA might respond if firms push back in the middle of an inspection
  
• Best practices for coordinating between the investigator, regional office and FDA headquarters if disagreements arise while an inspection is being conducted
  
• The key elements of a sound FDA inspection policy that will ensure your SOPs match the FDA’s intent, plus a sample inspection policy checklist to take back to your office

With so much concern about the final guidance – and so much at stake – this is a webinar you cannot afford to miss.

Sign up TODAY to attend Delaying, Denying, Limiting, Refusing Inspections What’s In The FDA Investigator’s New Handbook on December 16.

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