FDAnews Announces Create an Inspection Readiness Gap Analysis: How to Avoid the FDA’s Top 29 483 Citations, Webinar, Feb. 27, 2014

Many of the problems uncovered during inspections are common and recurring problems within the drug and device industry. In this webinar, Dr. David Lim, an accomplished former FDA official with CDRH and pharma executive, will describe the 29 problems that continually show up in 483s and warning letters, and explain why and how the FDA focuses on them.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) February 10, 2014

Create an Inspection Readiness Gap Analysis:
How to Avoid the FDA’s Top 29 483 Citations
**FDAnews Webinar**

Feb. 27, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/InspectionReadinessGap

Who's that sitting in the lobby?

Watch out … it may be the regional FDA inspector, just dropping by for an unannounced inspection of the facilities.

If this fictional scenario sounds like hype, then listen to what just happened to the folks at device and drug maker Hospira.

Late last year — with the holiday season approaching — the FDA broadsided a major pharma company with a series of warning letters at their facilities in Colorado, North Carolina, Kansas, Illinois and Costa Rica.

Why weren't the facilities better prepared? After all, many of the problems uncovered during their inspections are common within the drug and device industries.

Don't take the chance of being next in line for an unannounced inspection. Attend the webinar Create an Inspection Readiness Gap Analysis on Thursday, Feb. 27, 2014.

This webinar is sure to be an eye-opener, featuring a list of the 29 top problems that repeatedly show up in 483s and warning letters.

Dr. David Lim, an accomplished former FDA official with CDRH and a pharma executive, has pulled together this 29-point hot list by combing through data from FDA inspections over the last seven years. Step-by-step, he'll reveal why, and how, the FDA focuses on all 29 of them.

It's the best possible way to begin preparing an inspection readiness gap analysis. In 90 minutes, attendees will gain an understanding of where their facility's compliance weaknesses might be, and they’ll also learn:

  •     Why the 29 top problems continually show up in 483s, and how to best deal with these common citations
  •     What resources FDA investigators use to guide their inspections: IOMs, Inspection Guides, FMD and CPGM
  •     How the FDA manages inspection logistics: what regional office will conduct an investigation, and how the investigator will be picked
  •     Definitions of inspection types, categories and classifications
  •     What the difference is in FDA Forms 482, 483 and EIRs
  •     What (and how) to prepare for and respond to an FDA inspection
  •     Tips and best practices for communications before, during and after FDA inspections
  •     How to determine what the close out meeting should accomplish, and what companies should do if there are lingering disagreements during the meeting
  •     How best to respond to a 483, and who should reply to it: in-house staff or an outside counsel/consultant?
  •     How to reach continuous quality and inspectional readiness, plus best practices for achieving compliance and staying compliant year round

At a time when compliance resources are probably scarce, Dr. Lim's FDA inspection webinar is an excellent, affordable way to begin preparing an inspection readiness gap analysis. Sign up today.

Meet the Presenter:
Dr. David Lim, a former FDA employee, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia. He discovered a novel growth factor and published his thesis research in the prestigious journal “Science.” Since then, he has held various positions at Duke University Medical Center (Duke), California Institute of Technology (Caltech), University of California at Berkeley (UC-Berkeley), US National Laboratories, Intrexon, Terumo, US FDA/CDRH, and EraGen Biosciences (Luminex Company).

Who Will Benefit:

  •     Manufacturing directors
  •     Quality assurance
  •     Regulatory affairs
  •     Compliance
  •     Legal

Conference Details:
Create an Inspection Readiness Gap Analysis:
How to Avoid the FDA’s Top 29 483 Citations
**FDAnews Webinar**
Feb. 27, 2014 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/InspectionReadinessGap

Tuition:
$547 per site -- includes webinar registration and audio cds and transcripts

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