GCP Enforcement Trends - Webinar CD/Transcript

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GCP Enforcement Trends: Lessons Learned from FDA Inspections of Sponsors, Sites and IRBs

In 2014, the FDA conducted nearly 1,200 GCP inspections of clinical sites, IRBs, sponsors, monitors and CROs.

In 500 of those inspections — over 40 percent — the inspector found a problem.

Will you be among the 40 percent in 2015?

If you're thinking "maybe," do yourself and your company a big favor. Order the GCP Enforcement Trends: Lessons Learned from FDA Inspections of Sponsors, Sites and IRBs webinar CD and transcript.

The session is led by recognized industry expert Michael Swit, Esq., a food and drug law attorney since 1984. He has helped numerous life sciences firms stay in compliance with the FDA’s requirements, and his analysis of the agency’s GCP enforcement activities reveals some surprising lessons for the industry.

Swit's research shows that inspectors' top findings, by category, vary little from year to year, regularly including failure to follow the investigational plan … protocol violations … recordkeeping.  

Instead, he's found that the real lessons from inspection results lay not in the raw numbers, but in the details of the inspectional findings which lead to warning letters.
In 90 minutes, you'll learn about real-life inspection pitfalls and how to avoid them … hear about successful (and unsuccessful) attempts to prevent 483s from turning into warning letters … and gain insights from others' past mistakes, including:

  • The site that tried to solve its problems managing continuing review, only for the FDA to say the “improvements” actually made them worse.
  • A sponsor’s carefully-crafted informed consent documents that overlooked one of the most basic requirements.
  • The investigator who upended a trial by deviating from a basic element of the protocol without anyone noticing.
  • And more …

You'll come away from this session armed with a clearer understanding of exactly what the FDA inspectors like to hone in on during GCP inspections … and tested strategies for making sure the small problem discovered during your inspection doesn’t turn into a big one.

  • Regulatory affairs directors
  • Compliance officers
  • Legal counsel

Michael A. Swit, Esq., joined the Illumina legal department as senior director, legal, regulatory, in December 2014. Swit is a highly-experienced food & drug law attorney who has been been addressing critical FDA legal issues since 1984. His vast experience includes serving as vice president, general counsel and secretary of Par Pharmaceutical, a prominent generic drug company and, thus, he brings an industry and commercial perspective to his work.