Event Catalog
Browse 117 professional development events
Live Webinars
Instructor-led sessions with live Q&A
Excel Spreadsheets — Ensuring Data Integrity and 21 CFR Part 11 Compliance
Avoid FDA 483s by properly configuring and validating GxP-compliant Excel spreadsheets — with live step-by-step setup of audit trails, security features, and data entry verification.
David Nettleton
Complaint Handling and Investigation: Linking CAPA, MDR Reporting, Trend Evaluation, and Recall Considerations
This session examines complaint handling from a lifecycle perspective, focusing on how complaint information drives downstream quality and regulatory decisions.
Meredith Crabtree
Cleaning Validation Lifecycle Control: Monitoring Drift, Method Sensitivity, and Revalidation Decisions
This session examines cleaning validation from a lifecycle perspective, focusing on how organizations maintain confidence in validated cleaning processes long after initial approval.
Meredith Crabtree
Human-in-the-Loop (HITL) in GMP: Maintaining Human Oversight of AI-Assisted Decisions
Human-in-the-Loop is not simply having a person present. Effective HITL requires meaningful human oversight, defined decision authority, documented intervention, traceability, and lifecycle monitoring proportional to GMP risk.
Dr. Ginette CollazoChange Control for SaaS and AI Systems: Managing Configuration Drift and Revalidation Without Creating Validation Backlogs
Validating Interfaces Between GxP Systems: Data Transfers, APIs, Middleware, and Integration Failures
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 TroianoRecorded 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. LincolnConfiguration 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 Mora
ChatGPT-Assisted Technical Writing
Learn practical, compliant approaches to using ChatGPT for SOP drafting, document development, and technical writing in regulated industries.
Charles H. Paul