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Managing Outsourced Manufacturing: FDA Requirements and Collaboration Tools that Streamline Compliance
What you will learn:
Featuring Martin Browning, one of the leading authorities on FDA requirements and their effects on life sciences companies outsourcing any part of their operations. Mr. Browning has 22 years with the FDA as a local, national and international expert investigator, and has served as special assistant to the associate commissioner for regulatory affairs and vice chair of the agency's Electronic Records and Signatures Working Group, which drafted the 21 CFR Part 11 regulations.
For pharmaceutical companies engaged in outsourced manufacturing, this webcast provides a clear understanding of FDA requirements, which is critical since outsourcing any regulated part of their operation still leaves them wholly responsible for the quality and conduct of the supplier. From a leading pharmaceutical company, audience members will also be presented with real-life examples of challenges, best practices, and tools that have enabled success in addressing issues related to managing outsource manufacturing and the data collaboration required among outsource entities.
Tags: ERP, Enterprise Resource Planning, Manufacturing, outsource
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