FDA Inspections of Sponsors or Manufacturers

Clinical Trial Sting Operation
In a dramatic event, Congress recently performed a sting operation to see if an IRB took proper care in approving a clinical study. The New York Times reported that Congress invented a faux study, fabricated an investigator and his five page CV, listed the company's address as the PO Box in a shopping mall, and submitted the study to an IRB for approval. Why? Because some congressman feel that we don't do enough to evaulate the people we work with in clinical studies. While this is an unusual mechanism for initiating an inspection, it speaks to the intense concern our officials have about the cllinical research and device manufacturing process.

Why Do Inspections Occur?
Inspections can happen randomly (a new hire is being trained), for cause (someone complained), or by regulation (all manufacturing sites are inspected for PMA devices). But many inspections happen for political reasons: if you import components or devices from China, if you are one of the "big five" device companies, or if FDA can get positive visibility from your inspection to inspire other companies to comply on their own. How do you protect yourself?

Learning Objective
This presentation will focus on a number of the issues that typically arise during these challenging and important events, as well as suggestions for increasing the likelihood of a favorable outcome.

Mr. Shapiro and Mr. Donato will discuss
[x] Suggestions on preparing for an inspection.
[x] Interacting with FDA investigators during an inspection.
[x] Understanding the scope of the agency's inspectional authority.
[x] Dealing with any Form FDA 483.
[x] Special issues that arise during inspections of clinical trials that are intended to support 510(k) clearance or PMA Approval.

You will receive
[x] PowerPoint Slides.
[x] An understanding of the inspectional process, both for clinical studies and for manufacturing sites.
[x] Expert speakers with years of experience.
[x] A chance for Q&A.
[x] CEUs & Certificate.

Audience suitability
[x] Sponsors of clinical trials.
[x] Manufacturers of clinical devices.
[x] Monitors of clinical trials.
[x] Medical professionals involved in clinical trials.
[x] Data management professionals invoved in clinical trials.
[x] Managers of clinical trials.

Presenters
Mr. Jeff Shapiro is one of the directors at Hyman, Phelps & McNamara Law firm in Washington, D.C. Mr. Shapiro has represented health care companies on FDA-related matters since 1994. He advises companies on a wide variety of issues in the areas of medical devices, combination products, and human tissue products, including product approvals, marketing, clinical studies, jurisdictional issues, and enforcement. He can be reached at JShapiro@hpm.com.

Mr. Brian Donato is a member of the legal group at Hyman, Phelps & McNamara Law firm in Washington, D.C. since 1991. His practice includes providing information about various legal issues related to the Federal Food Drug and Cosmetic Act, FDA's regulations and similar laws and regulations. He is the recipient of an FDA Commissioner's Special Citation for his work in helping FDA communicate with members of the regulated industries. He is also the recipient of awards from FDLI, RAPS and The Orange County Regulatory Affairs Discussion Group. Mr. Donato can be reached at bdonato@hpm.com.

The purchase is $421 for OnDemand access and $471 itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.