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CMC Essentials Training Course (Tier 1)
Introductions and housekeeping
Introduction to the course
Housekeeping (5:18)
Module 1- The Journey of Drug Development
1.1- "From bench to bedside"
1.2- Drug manufacturing and CMC
1.3- The Regulatory framework of Drug Development
1.4- Career paths in Drug Development
Module 2- CTD Module 3: The Full Story of CMC
Roadmap to CMC - The CTD Module 3 (Full lecture) (53:29) (Ver 1.0)
Intro and resources
Chemistry, Manufacturing and Controls (27:47)
The Regulatory Context of CMC (14:06)
CMC in practice and introduction to GMP
The Science and Technology of CMC
Module content
Types of pharmaceutical products- from Small Molecules to Cell Therapy
Key Manufacturing Technologies- from Molecular Biology to Downstream processing
Manufacturing sites and GMP
Module content
Manufacturing sites (In-house/CMOs)
Good Manufacturing Practice 101
From Lab to GMP- a typical workflow
Manufacturing Process Development (Drug Substance)
Live Session 4
Upstream Process Development, Starting Materials and Cell Banks
Downstream Process Development
Process "lock" and Comparability (intro)
Pharmaceutical Development and Product Lifecycle
Live Session 5
Pharmaceutical Development
Formulation Development
Drug Product Development: Manufacturing Process, Container and Labelling
Case study: Intranasal Products
Comparability
Technology Transfers
Know thy product- Characterization and Impurities
Live Session 6
Characterzation
Impurities
Quality Controls (QC)
Live Session 7
Analytical methods
Quality Controls (QC)
Analytical methods lifecycle and validation
When the product meets the world
Live Session 8
Stability and shelf life
CMC operations
Pharmaceutical Quality and Design
Live Session 9
Quality Assurance (QA)
Pharmaceutical Quality Systems
Quality Risk Management
Introduction to QBD
The view from the top of the mountain
Live Session 10
Quick recap of all course topics
Oceans of data
Pharma 4.0 and Beyond
Final housekeeping and takeaway gift
Quiz
THANK YOU!
The Regulatory Context of CMC
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