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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.
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:
With so much concern about the final guidance – and so much at stake – this is a audio CD/transcript you cannot afford to miss.
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.
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