FDAnews Announces — GCP Enforcement Trends: Lessons Learned from FDA Inspections of Sponsors, Sites and IRBs Webinar, July 21, 2015

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In 2014, the FDA conducted nearly 1,200 GCP inspections of clinical sites, IRBs, sponsors, monitors and CROs. In 90 minutes, webinar attendees will 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.

GCP Enforcement Trends:
Lessons Learned from FDA Inspections of Sponsors, Sites and IRBs
**FDAnews Webinar**
July 21, 2015 — 1:30 9.m. – 3:00 p.m. EDT
http://www.fdanews.com/gcpenforcementtrends

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.

Avoid becoming one of the 40 percent in 2015. Register now for the must-attend webinar GCP Enforcement Trends: Lessons Learned from FDA Inspections of Sponsors, Sites and IRBs on Tuesday, July 21, 2015.

The webinar will be 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, attendees will 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 …

Attendees will come away from this webinar 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 anr inspection doesn’t turn into a big one.

Meet the Presenter:
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.

Who Will Benefit:

  • Regulatory affairs directors
  • Compliance officers
  • Legal counsel

Webinar Details:
GCP Enforcement Trends:
Lessons Learned from FDA Inspections of Sponsors, Sites and IRBs
**FDAnews Webinar**
July 21, 2015 — 1:30 9.m. – 3:00 p.m. EDT
http://www.fdanews.com/gcpenforcementtrends

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/gcpenforcementtrends
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
+1 (703) 538-7665
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