Event Catalog

A risk-based framework for vendor assurance of AI-enabled and cloud-based GxP systems: which vendor evidence you can leverage, which claims you must challenge, and which controls or outcomes you must independently verify.

Understand the operational impact of ICH Q14 and Q2(R2) on analytical method development, validation, transfer, and lifecycle management in regulated pharmaceutical environments.

Meredith Crabtree

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 Esposito

Learn how to measure and improve SOP effectiveness across training, qualification, GMP operations, and AI-assisted environments — connecting documentation, compliance, and workforce performance.

Michael Esposito

Build a compliant and effective GMP onboarding program — cover training coordination, contractor vs. employee differences, and how to reduce the compliance learning curve.

Michael Esposito

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

Fix bad SOPs at the source — a 3-hour course covering SOP writing parameters, training development, curriculum design, LMS considerations, and ongoing knowledge retention assessment.

Michael Esposito

Build GCP audit and inspection readiness — cover QMS, SOPs, documentation, internal audits, and personnel training to ensure compliant clinical trial execution.

Charles H. Paul

This course helps sponsors establish a clearer oversight strategy, align supplier arrangements with ICH-GCP E6(R3), and prepare documentation and contractual evidence that supports inspection readiness.

A risk-based framework for vendor assurance of AI-enabled and cloud-based GxP systems: which vendor evidence you can leverage, which claims you must challenge, and which controls or outcomes you must independently verify.

Understand the operational impact of ICH Q14 and Q2(R2) on analytical method development, validation, transfer, and lifecycle management in regulated pharmaceutical environments.

Meredith Crabtree

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. Sundar

Learn how to measure and improve SOP effectiveness across training, qualification, GMP operations, and AI-assisted environments — connecting documentation, compliance, and workforce performance.

Michael Esposito

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 Esposito