FDAnews Announces — Delaying, Denying, Limiting, Refusing Inspections: What’s in the FDA Investigator’s New Handbook Webinar, Dec. 16, 2014

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To help manufacturers better understand the final guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing to Permit Drug Inspection,” FDAnews has engaged FDA inspections expert and attorney Lynn C. Tyler to lead a 90-minute webinar on the subject on Dec. 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.

Delaying, Denying, Limiting, Refusing Inspections:
What’s in the FDA Investigator’s New Handbook
**FDAnews Webinar**
Dec. 16, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/DelayingDenyingInspections

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

  • 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 an inspection handling SOPs say no photographs, is this really “limiting” an investigator?
  • 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.
  • Plus, many have been scratching their heads about how to interpret words like “reasonable”, “timely” and “without adequate justification.” So, where does a manufacturer bend and where does it stand firm?

What does all this mean? 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 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 SOPs match the FDA’s intent, plus a sample inspection policy checklist

With so much concern about the final guidance, and so much at stake, this is a webinar not to be missed.

Meet the Presenter:

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.

He is co-chair of the Biosimilars Subcommittee for the AIPLA's Biotech Committee and is the vice chair of AIPLA's Food and Drug Committee, and a member of the FDLI's Medical Device Committee. He is a member of the 7th Circuit, Federal Circuit, and Indiana State Bar Associations.

Who Will Benefit:

  • 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

Webinar Details:
Delaying, Denying, Limiting, Refusing Inspections:
What’s in the FDA Investigator’s New Handbook
**FDAnews Webinar**
Dec. 16, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/DelayingDenyingInspections

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/DelayingDenyingInspections
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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