Showing results by author "Meranda Parascandola Ed Narke" in All Categories
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CMC Live - Chemistry, Manufacturing & Controls
- Written by: Meranda Parascandola Ed Narke
- Original Recording
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FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content ...
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