Event Catalog
Browse 117 professional development events
Using SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions
Learn how SPC, Six Sigma, and process data support CGMP production controls — sampling plan justification, verification/validation, and trend analysis for non-conformances, complaints, and CAPAs.
John E. Lincoln
Aseptic 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
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
OTC Monograph Reform and OMUFA II: What FDA's Modernized OTC Framework Means for Manufacturers
Understand the practical impact of FDA's modernized OTC monograph system and OMUFA II obligations on daily regulatory, quality, manufacturing, and compliance decisions.
Meredith Crabtree
Packaging and Labeling Controls: Reducing Hidden Errors Before They Escalate
Understand how to reduce hidden packaging and labeling errors in pharmaceutical manufacturing — covering proactive controls, AI-driven process improvements, and supply chain performance strategies.
Michael EspositoUsing SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions
Learn how SPC, Six Sigma, and process data support CGMP production controls — sampling plan justification, verification/validation, and trend analysis for non-conformances, complaints, and CAPAs.
John E. Lincoln
Process Validation Requirements and Compliance Strategies
Recalibrate your process validation program — connect IQ/OQ/PQ to FDA and ISO frameworks and build robust, reliable processes that withstand regulatory scrutiny.
José MoraDetermining Root Cause in Sterility Failure Investigations
A practical investigation framework for tracing sterility failures through laboratory, manufacturing, environmental, and contamination-source evidence to establish a defensible root cause, determine the impact on affected batches, and support appropriate corrective actions.
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. PaulRecording available
OTC Monograph Reform and OMUFA II: What FDA's Modernized OTC Framework Means for Manufacturers
Understand the practical impact of FDA's modernized OTC monograph system and OMUFA II obligations on daily regulatory, quality, manufacturing, and compliance decisions.
Meredith CrabtreeRecording available
Aseptic 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 CrabtreeRecording available
Packaging and Labeling Controls: Reducing Hidden Errors Before They Escalate
Understand how to reduce hidden packaging and labeling errors in pharmaceutical manufacturing — covering proactive controls, AI-driven process improvements, and supply chain performance strategies.
Michael EspositoRecording available