National Costume: Gain in-depth knowledge of Chemistry, Manufacturing and Controls (CMC)

Tuesday, April 18, 2023

Gain in-depth knowledge of Chemistry, Manufacturing and Controls (CMC)

Greetings!

The objective of this course is to provide a strong understanding of the importance and underlying principles for CMC requirements from the regulatory perspective. Participants will gain an understanding of the CMC portion of a Common Technical Document (CTD) which is the format that regulatory submissions in Canada and the EU must be filed.

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Course Outline

The following specific topics will be addressed in detail:

Role of CMC in drug development
Nomenclature and characterization of drug substance
Analytical methods and validation
Manufacturing, in-process controls and process validation
Developing drug substance and drug product specifications
Stability, stability-indicating tests and how much change is acceptable
Regulatory expectations for product characterization
Drug Master Files
Structure, content and components relating to CMC section of a regulatory submission