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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:
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.
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