FDAnews Announces: How to Make Your Quality Control Unit Produce Quality Work Webinar, March 25, 2015

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CFR Sec. 211.22 — responsibilities of a quality control unit — is only a scant 163 words, but this language has created constant problems for drug and biologics manufacturers. For the past 10 years failure to properly manage quality control units (QCU) has been at the top of the FDA’s Form 483 and warning letter citations.

How to Make Your Quality Control Unit Produce Quality Work
**FDAnews Webinar**
March 25, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/QualityControlQualityWork

CFR Sec. 211.22 — responsibilities of a quality control unit — is only a scant 163 words. But this language has created constant problems for drug and biologics manufacturers. For the past 10 years failure to properly manage quality control units (QCU) has been at the top of the FDA’s Form 483 and warning letter citations.

In this webinar attendees will learn:

  •     Nine critical expectations of the QCU — these are the basis for what the FDA is looking for during an inspection
  •     An 8-year historical breakdown of CFR 211.22 citations so you can learn from the mistakes of others
  •     FDA’s current view on specific failures and why this issue continues
  •     Four best practices to ensure management of an effective QCU
  •     Analysis of recent industry data that will help identify weaknesses operations and help diagnose issues and prevent 483 observations

Meet the Presenter:
Crystal Mersh, Executive Partner with QxP Inc., is a recognized leader in the field of QCU. She was Vice President of Quality Management at Novartis for more than eight years. At QxP, she provides expertise, consulting, coaching, and strategic/organizational planning for services for quality and compliance aspects for the pharma/medical device industry. She has extensive experience in remediation, consent decree management, warning letter resolution and continuous improvement of quality systems, workflows and quality operations.

Who Will Benefit:

  •     QA/QC managers and directors
  •     Compliance personnel
  •     Regulatory affairs professionals
  •     Production managers
  •     Production supervisors
  •     Quality inspection and test managers
  •     Process development staff
  •     Training managers

Conference Details:
How to Make Your Quality Control Unit Produce Quality Work
**FDAnews Webinar**
March 25, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/QualityControlQualityWork

Tuition:
$287 per site

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