FDAnews Announces — CDRH Enforcement Trends: Back to the Future Webinar, Feb. 25, 2016

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Warning letters tend to cause a drop in company evaluation and a drop in company revenue — the executive team, shareholders, and patients don’t want to see a warning letter. SOPs need to be simple enough to follow yet complete enough to satisfy intense scrutiny.

CDRH Enforcement Trends:
Back to the Future
Feb. 25, 2016 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/cdrhenforcementtrends

As Winston Churchill said, “Those who don’t learn from history are doomed to repeat it.”

An analysis of CDRH’s enforcement actions in 2015 will show what to expect when they come knocking this year. But that takes time.

Take a close look at the warning letters the agency sent last year, and there will be the usual suspects — GMP lapses, poor CAPA practices, quality audit issues — but also a more laser-like focus on device makers who don’t seek premarket approval for alternative uses of their products. Also raising its head — a lack of or inadequate employee training and an old standby that can’t be possibly be ignored — lack of or inadequate procedures.

SOPs need to be simple enough to follow yet complete enough to satisfy intense scrutiny. It’s better to have a simple flowchart to follow than a 30-page tome that looks great on paper but has dust settling on the cover due to lack of use.

The bottom line is that warning letters tend to cause a drop in company evaluation and a drop in company revenue — the executive team, shareholders, and patients don’t want to see a warning letter.

This practical webinar will detail exactly what FDA enforcers were focusing on last year. It will also project forward to let attendees know what they’re likely to see from FDA enforcers when they come and visit the facility this year.

Meet the Presenter:
John Avellanet, Founder, Cerulean Associates LLC

John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style. Mr. Avellanet was the lead author of several certification courses on Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) supplier management for the US Regulatory Affairs Professional Society.

Who Will Benefit:

  • Compliance personnel
  • Regulatory affairs professionals
  • QA/QC personnel
  • Manufacturing executives
  • 510K application specialists
  • Strategic planner
  • Pharmaceutical scientists

Webinar Details:
CDRH Enforcement Trends:
Back to the Future
Feb. 25, 2016 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/cdrhenforcementtrends

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/cdrhenforcementtrends
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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