Syllabus
CMC Regulatory Affairs Professional Certificate
36 lessons, about 16 hours. Online and self-paced, with a certificate when you finish.
Regulatory Foundations and Dossiers
Establishes the U.S. regulatory framework, CMC professional responsibilities, CTD organization, electronic submission standards, and documentation controls required throughout pharmaceutical development and commercialization.
- 1CMC Regulatory Pathways and Strategy
- 2CTD Quality Structure and Source Traceability
- 3eCTD Format and Validation
Small-Molecule Module 3
Develops the ability to construct and critically review a complete small-molecule quality dossier, from active pharmaceutical ingredient synthesis through finished-product controls and regulatory submission readiness.
- 4Drug Substance Manufacturing Dossier
- 5Drug Substance Characterization and Controls
- 6Oral Solid Development and Manufacture
- 7Drug Product Stability and Packaging
- 8Small Molecule Dossier Review Workshop
Therapeutic Biologic Module 3
Builds product-specific biologics CMC competence covering cell substrates, bioprocessing, viral safety, potency, aseptic manufacture, stability, and BLA dossier assembly.
- 9Cell Banks and Upstream Manufacture
- 10Purification Characterization and Viral Safety
- 11Biologic Formulation and Aseptic Production
- 12Potency Specifications and Biologic Stability
- 13Biologic Module Three Evidence Workshop
Quality by Design Controls
Teaches learners to identify quality-critical attributes, evaluate process risks, justify design-space decisions, and build integrated commercial control strategies for both small molecules and biologics.
- 14Critical Attribute Linkage Matrix
- 15Process Risk and Design Space
- 16Commercial Control Strategy Design
- 17Process Validation and Continued Verification
- 18Paired Control Strategy Workshop
Analytical Quality and Stability
Develops the ability to evaluate analytical methods, electronic records, specifications, batch-release evidence, stability, impurities, and packaging risks as a regulatory CMC reviewer.
- 19Analytical Method Development and Validation
- 20Laboratory Records and Computerized Controls
- 21Specifications Batch Release and Stability
- 22Impurity Nitrosamine and Packaging Assessment
Postapproval Change Reporting
Teaches U.S. regulatory classification, implementation timing, evidence requirements, annual reporting, and separate product-quality notification obligations for manufacturing changes.
- 23NDA and ANDA Change Categories
- 24BLA Change Categories and Implementation
- 25Regulatory Change Assessment and Annual Reports
- 26Field Alerts and Biologic Deviations
- 27Cross Product Change Classification Workshop
ICH Q12 Lifecycle Management
Develops practical use of Established Conditions, postapproval change management protocols, and lifecycle documentation to make future CMC changes more predictable without bypassing U.S. regulatory requirements.
- 28Established Conditions and Regulatory Commitments
- 29Module Three Established Conditions Annotation
- 30Postapproval Change Management Protocol Design
- 31Product Lifecycle Management Strategy
Biologics Comparability Capstone
Integrates biologic quality science, manufacturing-change risk, comparative analytical evidence, Module 3 updates, FDA filing decisions, and regulatory documentation into a complete professional capstone.
- 32Q5E Manufacturing Comparability Risk Assessment
- 33Comparability Analytical Study Design
- 34Batch Evidence and Residual Uncertainty
- 35Biologic Process Change Filing Decision
- 36Integrated Regulatory Comparability Capstone