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CMC and Quality

The Regulatory CMC (Chemistry, Manufacturing and Controls) and Product Quality Track provides a comprehensive overview of risk-based approaches throughout the product lifecycle. The scope of the track spans scientific understanding gained through product and process development to lifecycle expectations for Global Regulatory CMC submissions, CGMP, and Quality Systems. Sessions address the increasing regulatory complexity in development and manufacturing for worldwide markets, accelerated development timelines, new technologies, emerging regulations and the increasing scrutiny of manufacturing operations and data.

Who is This Track Designed For?

Professionals involved in regulatory affairs and policy, manufacturing, quality assurance, quality control, drug development and/or manufacturing for small molecule drugs, biologics and vaccines

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