Event Catalog
Browse 117 professional development events
EO Sterilization Validation and Revalidation Under ISO 11135: Practical Implementation and Lifecycle Considerations
Learn the ISO 11135 requirements for EO sterilization validation and periodic revalidation — covering equipment IQ/OQ/PQ, overkill approach, sterile load V&V, BIs/PCDs, and lifecycle controls for medical devices.
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 CrabtreeStep-by-Step Process for Successful Sterility Failure Investigations
A step-by-step guide to investigating sterility test failures — covering FDA regulations, root cause tools, lot impact assessment, and audit-ready documentation.
Danielle DeLucyDetermining 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.
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
EO Sterilization Validation and Revalidation Under ISO 11135: Practical Implementation and Lifecycle Considerations
Learn the ISO 11135 requirements for EO sterilization validation and periodic revalidation — covering equipment IQ/OQ/PQ, overkill approach, sterile load V&V, BIs/PCDs, and lifecycle controls for medical devices.
John E. LincolnRecording available