Event Catalog
Browse 71 professional development events
Live Webinars
Instructor-led sessions with live Q&A
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 Collazo
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. FetzerChatGPT-Assisted Technical Writing
Learn practical, compliant approaches to using ChatGPT for SOP drafting, document development, and technical writing in regulated industries.
Charles H. Paul
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 Crabtree
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. Lincoln
Data Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR
Get complete clarity on 21 CFR Part 11, Annex 11, SaaS/Cloud compliance, AI software validation, and EU GDPR requirements for regulated industries.
David NettletonVirtual 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
Statistical Process Control (SPC) and Control Charts for Laboratory Compliance
Use SPC and control charts to build a proactive laboratory compliance system — monitor performance variables, apply Nelson Rules, and align with 21 CFR Part 211.160 and ISO 17025.
Dr. John C. FetzerExcel Spreadsheets — Ensuring Data Integrity and 21 CFR Part 11 Compliance
Avoid FDA 483s by properly configuring GxP-compliant Excel spreadsheets — step-by-step setup of audit trails, security features, Part 11 compliance, and minimal-documentation validation.
David NettletonCSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See
Break through CSV conditioning — learn how to build FDA-defensible evidence using CSA, size effort with risk-based thinking, and align with GAMP 5 (2nd Edition) without the paperwork burden.
Carolyn TroianoQuality Metrics & KPIs: How to Measure What the FDA Actually Cares About
Understand the latest global regulatory requirements for quality metrics and KPIs — learn to implement, align, and report metrics that satisfy FDA inspection scrutiny.
Meredith CrabtreeChatGPT and AI-Powered Project Management — Revolutionize Your Projects Now
Harness ChatGPT and AI tools to streamline workflows, automate routine project tasks, and improve decision-making accuracy across the full project management lifecycle.
Charles H. PaulThe Smart Way to Classify Cloud GxP Systems Before You Validate — 3-Hour Course
A 3-hour course on classifying cloud GxP systems with precision using CSA — assess intended use, GxP relevance, risk, and shared responsibility before validation begins.
Carolyn Troiano