Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process On Demand TrainingCourse
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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 training 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 allow you to apply several of the principals learned to real-life situations and to arm yourself with 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 non-compliance evidence
Description
At the conclusion of this course, participants should be able to:
- Recognize FDAs regulatory expectations and the regulatory framework
- Outline the CMC sections of INDs/NDAs/CTDs/DMFs
- Define the CMC sections of INDs and NDAs/CTDs
- Identify regulatory documents affected by CMC
- Define the FDA expectations regarding pediatric formulations
- Determine how to design labels required for INDs and NDAs
- Define the FDA inspection process and how to avoid or minimize 483s and Warning Letters
- Identify ways to construct a stability protocol