Event Catalog

A step-by-step guide to investigating sterility test failures — covering FDA regulations, root cause tools, lot impact assessment, and audit-ready documentation.

Danielle DeLucy

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

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