Event Catalog

Understand what constitutes sufficient and defensible IQ, OQ, PQ, and PPQ validation evidence in modern GMP environments — with real-world examples.

Meredith Crabtree

Develop a Master Validation Plan and defensible IQ, OQ, PQ protocols aligned with FDA cGMP, ICH Q9, ISO 13485, and ISO 14971 risk management standards.

John E. Lincoln

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

Recalibrate your process validation program — connect IQ/OQ/PQ to FDA and ISO frameworks and build robust, reliable processes that withstand regulatory scrutiny.

José Mora