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. Fetzer
Excel 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 Nettleton
CSA 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 Troiano
Quality 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 TroianoThe CSA Playbook for SaaS, PaaS & Modern Digital Platforms — 3-Hour Course
A 3-hour CSA playbook for SaaS and PaaS validation — learn to evaluate vendor evidence, interpret SOC reports, separate responsibility, and build FDA-defensible documentation.
Carolyn TroianoHow to Validate Automated Pipelines Under CSA — 3-Hour Course
A 3-hour course on validating CI/CD pipelines and automated workflows under CSA — challenge-based testing, automated evidence, and maintaining audit readiness in rapid-release environments.
Carolyn TroianoPart 11, Data Integrity & Documentation for SaaS/PaaS Validation — 3-Hour Course
A 3-hour deep dive into 21 CFR Part 11 and data integrity for SaaS/PaaS cloud systems — covering audit trails, shared responsibility, change management, and FDA inspection readiness.
Carolyn TroianoFDA Labeling and UDI Essentials for Medical Products
Turn FDA labeling and UDI requirements into a controlled, inspection-ready system — cover 21 CFR 801, DMR linkage, misbranding risk, IFUs, and GUDID compliance.
José MoraIQ, OQ, PQ in the Verification and Validation Process
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
Onboarding In A GMP Environment — Best Practices
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