Delaying, Denying, Limiting, Refusing Inspections - Webinar CD/Transcript

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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. 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. 

Listen to 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 audio CD/transcript you cannot afford to miss.

  • Compliance officers
  • Executive management
  • General/corporate counsel
  • Investigators
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • Regulatory/legislative affairs professionals
  • Risk management specialists

Lynn C. Tyler is a partner in Barnes and Thornburg’s Indianapolis, Ind. office and chairs the firm’s Food, Drug and Device Law Practice Group. He counsels food and drug industry clients on matters such as advertising and promotion, FDA inspections, imports, labeling, registration, reporting and packaging.  He also works with medical device companies on matters such as inspections, IDEs, 510(k)s, and labeling and promotion issues.
Mr. Tyler is an accomplished author of industry articles and books and also teaches throughout the industry.  He graduated summa cum laude in 1981 from the University of Notre Dame and received his J.D. magna cum laude from the University of Michigan Law School in 1984. He also received a M.S. in biology from IUPUI in 2007. He was a member of the Michigan Law Review and elected to the Order of Coif.