Event Catalog
Browse 71 professional development events
Drug Master Files (DMFs) — Understanding and Meeting Your Global Regulatory and Processing Responsibilities
Master Drug Master File creation, submission, and lifecycle management — navigate FDA and EMA requirements, protect proprietary information, and maintain global regulatory compliance.
Charles H. Paul
How to Conduct Annual Product Reviews to Achieve GMP Compliance
Learn how to write compliant Annual Product Quality Reviews (APRs) — covering regulatory requirements, what to include, and how well-written APRs strengthen your compliance position.
Danielle DeLucy
Advanced Therapy GMP Release and Chain-of-Identity Controls
Learn how to establish chain-of-identity controls, manage GMP release decisions, and build traceability systems for cell therapy, gene therapy, and ATMP manufacturing.
Charles H. Paul
Nitrosamines After the Initial Assessment: When Does a Change Trigger Reassessment and How Should Impact Be Evaluated
Master the complex decisions that follow post-approval changes — when nitrosamine reassessment is mandatory, when scientific rationale suffices, and how to evaluate NDSRI impact using CPCA under ICH M7.
G. SundarAseptic Processing and Contamination Control Under EU GMP Annex 1: Practical Applications for Modern Sterile Operations
Learn how to apply EU GMP Annex 1 contamination control principles in practice — covering CCS, environmental monitoring signals, aseptic interventions, and sterility assurance decisions.
Meredith Crabtree