The regulations surrounding Chemistry, Manufacturing, and Controls (CMC) can often seem daunting and challenging. However, with the proper training and knowing where to look amongst the FDA regulations and other important resources, you can become an informed and knowledgeable regulator that can tackle CMC issues. This on-demand course has been assembled for the beginner in CMC as well as the intermediate professional who is looking for a refresher course in several facets of CMC. This course will review the tools to write and/or assemble CMC sections of regulatory submissions (INDs, NDAs, DMFs, ANDAs, etc.), prepare for and orchestrate CMC meetings with the FDA, and provide a clear understanding on how to avoid noncompliance. While the course is primarily focused on CDER and some CBER related products, some biologics and device CMC specific requirements will also addressed.

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