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 that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT…
024 - Quality Management Systems Explained!
👤 Episode 1
023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel
👤 Episode 2
022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly
👤 Episode 3
021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola
👤 Episode 4
020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke
👤 Episode 5
019 - Complexity of Project Management in Drug Development with Paul Long
👤 Episode 6
018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola
👤 Episode 7