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Track 10: Regulatory CMC and Product Quality

DIA 2017: Driving Insights to Action

The Regulatory CMC and Product Quality Track has 10 sessions and provides a comprehensive view of risk-based approaches across the product lifecycle. With themes in CMC, Product Quality, New Technology and Innovation, FDA Initiatives, and International Harmonization, the track scope spans from the scientific understanding gained through product and process development to lifecycle expectations for Global Regulatory CMC submissions, CGMP, and Quality Systems. Sessions will address the increasing regulatory complexity of development and manufacturing for worldwide markets, accelerated development timelines, new technologies, emerging regulations, and increased scrutiny of manufacturing operations and data.

Sessions in Regulatory CMC and Product Quality

Monday, June 25

Tuesday, June 26

Wednesday, June 27

Who is This Track Designed For?

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

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