Event Catalog
Browse 120 professional development events
Live Webinars
Instructor-led sessions with live Q&A
Digital Quality Metrics and AI/ML Analytics: Building a Continuous-Improvement Framework that Aligns with Regulatory Expectations
Learn how AI/ML and real-time digital quality metrics build a continuous-improvement framework aligned with FDA regulatory expectations, 21 CFR Part 11, and GAMP®5.
Carolyn TroianoRecording available
AI in GMP: What the FDA Is Already Expecting - Before You Ask
FDA already expects GMP compliance for AI systems. Learn how existing validation, data integrity, and oversight rules apply—before regulators come calling.
Dr. Ginette CollazoRecording available
HPLC Analytical Method Development and Validation
Master HPLC instrument and method validation to meet US EPA and FDA requirements for pharmaceutical analysis.
Dr. John C. FetzerRecording available
ChatGPT-Assisted Technical Writing
Learn practical, compliant approaches to using ChatGPT for SOP drafting, document development, and technical writing in regulated industries.
Charles H. PaulRecording available
IQ, OQ & PQ in 2026: What Now Counts as Sufficient Validation Evidence
Understand what constitutes sufficient and defensible IQ, OQ, PQ, and PPQ validation evidence in modern GMP environments — with real-world examples.
Meredith CrabtreeRecording available
Root Cause Analysis for GMP Investigations: Identifying Systemic Failures and Building Effective CAPA
Master closed-loop CAPA with repeatable failure investigation and root cause analysis tools that satisfy FDA audit expectations in GMP environments.
John E. LincolnRecording available
Virtual Seminars
Multi-session structured programmes
Risk-Based CSV/CSA for Modern GxP Systems: Making Defensible Validation Decisions in Practice
A two-day, risk-based framework for CSV/CSA and GAMP® 5 validation decisions on modern GxP systems — cloud, SaaS, configurable, and AI-enabled platforms — built for inspection readiness.
Carolyn TroianoRecording available
Recorded Webinars
On-demand recordings, watch any time
Vendor Assurance for AI and Cloud-Based GxP Systems: What You Can Leverage, Challenge, and Independently Verify
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.
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
Beyond Digital Batch Records: Managing FDA and EU GMP Documentation While Preserving Data Integrity
Learn how digital/electronic DHF, DMR, DHR, and EU MDR Technical Documentation improves data integrity, reduces human error, and simplifies global regulatory compliance.
John E. Lincoln
Configuration Control vs. Document Control – Managing Design Changes Across Modern Quality Systems
Learn why Configuration Architecture — not Document Control — defines the modern Quality System, and how treating relationships as first-class objects strengthens traceability, change control, and inspection readiness.
José MoraQMSR Device Records: Structuring DDF, MDF and Related Relationships for Inspection Readiness
Learn how to structure QMSR Device Records using Lean Documents and Lean Configuration principles to achieve true inspection readiness through relationship integrity, not just document control.
José MoraChatGPT-Assisted Technical Writing
Learn practical, compliant approaches to using ChatGPT for SOP drafting, document development, and technical writing in regulated industries.
Charles H. Paul