Simplifying Global Compliance
How to Make Your Quality Control Unit Produce Quality Work - Webinar CD/Transcript
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How to Make Your Quality Control Unit Produce Quality Work
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 presentation you 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 for ensuring you’re managing an effective QCU
- Analysis of recent industry data that will help identify weaknesses in your operations and help diagnose issues and prevent 483 observations
- QA/QC managers and directors
- Compliance personnel
- Regulatory affairs professionals
- Production managers
- Production supervisors
- Quality inspection and test managers
- Process development staff
- Training managers
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.