Event Catalog
Browse 71 professional development events
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 CollazoChatGPT-Assisted Technical Writing
Learn practical, compliant approaches to using ChatGPT for SOP drafting, document development, and technical writing in regulated industries.
Charles H. Paul
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 NettletonAI Errors May Be Impossible to Eliminate — What That Means for Its Use in the FDA
AI errors may be statistically unavoidable. Learn how to build controls, oversight, and governance models that make AI safe, compliant, and inspection-ready in FDA-regulated environments.
Dr. Ginette Collazo
AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to Defend
AI can detect signals — but regulators will still expect humans to interpret, defend, and document post-market surveillance decisions. Learn what that looks like under FDA and EU MDR.
Meredith CrabtreeExcel 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 NettletonAnnex 22 and AI Governance for GMP: Human Review, Model Monitoring, and Change Control
Meet EU Annex 22 AI governance requirements in GMP — covering human review, model monitoring, change control, CSV vs CSA, GAMP®5, and inspection readiness for AI/ML systems.
Carolyn Troiano
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 Troiano
The First FDA Warning Letter on AI: What It Means for Your Quality System
The FDA issued its first AI-related Warning Letter. Learn what it means for your QMS, validation requirements, and how to keep your quality systems inspection-ready.
Dr. Ginette Collazo
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 TroianoUsing SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions
Learn how SPC, Six Sigma, and process data support CGMP production controls — sampling plan justification, verification/validation, and trend analysis for non-conformances, complaints, and CAPAs.
John E. LincolnAI and Decision Making in GMP: Resolving Conflicts Between Human Judgment and AI Recommendations
Learn how to govern AI-assisted decisions in GMP operations — when to trust AI recommendations, when human judgment must override them, and how to document it all for inspection readiness.
Dr. Ginette Collazo
Analytical Lifecycle Management Under ICH Q14 and Q2(R2): What Changes Operationally
Understand the operational impact of ICH Q14 and Q2(R2) on analytical method development, validation, transfer, and lifecycle management in regulated pharmaceutical environments.
Meredith CrabtreeExcel 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 NettletonChatGPT 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. PaulHow 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 MoraOnboarding 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 EspositoDrug Master Files (DMFs) — Understanding and Meeting Your Global Regulatory and Processing Responsibilities
Master Drug Master File creation, submission, and lifecycle management — navigate FDA and EMA requirements, protect proprietary information, and maintain global regulatory compliance.
Charles H. PaulBad Standard Operating Procedures (SOPs) — Bad Training: Garbage In, Garbage Out — 3-Hour Course
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 EspositoFDA Inspections After QMSR: What Replaces QSIT 2.0 — The New Inspection Reality
Understand the new QMSR inspection reality — what replaces QSIT, how FDA will inspect under ISO 13485 alignment, and how to manage the hybrid compliance burden of QSR + QMSR.
John E. LincolnProject Management Best Practices for Computer Systems Regulated by FDA
Apply project management best practices to FDA-regulated computer system implementations — covering SDLC, CSV, GAMP V, roles, documentation, and maintaining systems in a validated state.
Carolyn TroianoStep-by-Step Process for Successful Sterility Failure Investigations
A step-by-step guide to investigating sterility test failures — covering FDA regulations, root cause tools, lot impact assessment, and audit-ready documentation.
Danielle DeLucyAI for CAPA and Investigations: Where It Helps and Where It Can Get You in Trouble
Learn where AI genuinely helps CAPA and investigations — and where it creates regulatory risk by replacing evidence-based analysis with generated logic.
Charles H. Paul
Advanced Therapy GMP Release and Chain-of-Identity Controls
Learn how to establish chain-of-identity controls, manage GMP release decisions, and build traceability systems for cell therapy, gene therapy, and ATMP manufacturing.
Charles H. Paul
OTC Monograph Reform and OMUFA II: What FDA's Modernized OTC Framework Means for Manufacturers
Understand the practical impact of FDA's modernized OTC monograph system and OMUFA II obligations on daily regulatory, quality, manufacturing, and compliance decisions.
Meredith CrabtreeAcceptance Criteria for AI Validation: Determining What "Reliable" Actually Means in GxP Systems
Learn how to define meaningful, risk-based acceptance criteria for AI systems in GxP environments — covering reliability thresholds, hallucination controls, human guardrails, and CSA-aligned validation strategies.
Carolyn TroianoMeasuring SOP Effectiveness Across Training, Qualification, GMP Operations, and AI-assisted environments
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
Audit Trail Review by Exception: Reducing Reviewer Burden Without Weakening Detection
Learn how to implement a risk-based audit trail review-by-exception strategy that reduces reviewer fatigue while strengthening detection of critical compliance, data integrity, and cybersecurity risks.
Carolyn TroianoUsing EU GMP Annex 22 as the Framework for Governing AI Systems, Validation Traceability, and Data Integrity Controls
Learn how to apply EU GMP Annex 22 as a practical framework for AI system governance, validation traceability, lifecycle management, and data integrity controls in regulated pharmaceutical and biotech environments.
Charles H. Paul
Packaging and Labeling Controls: Reducing Hidden Errors Before They Escalate
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
AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to Defend
AI tools can detect signals — but regulators still expect humans to interpret, escalate, and defend every post-market surveillance decision under FDA and EU MDR.
Meredith CrabtreeData Integrity and Documentation Excellence
Go beyond theory — understand how ALCOA+ appears in real records, how Part 11 applies to electronic systems, and how to design documentation that withstands audits.
Charles H. PaulLeveraging AI in Risk Assessment for Smarter Computer Systems Validation
Apply AI responsibly to CSV risk assessment — build defensible, inspection-ready risk models that align with CSA, GAMP 5, and FDA data integrity expectations.
Carolyn TroianoDeviations, CAPA and Change Control
Move beyond superficial root causes — build defensible deviation reports, sustainable CAPA, and change control aligned with 21 CFR 820.100 and GMP expectations.
Charles H. PaulCybersecurity Expectations for GxP Systems
Translate FDA cybersecurity expectations into inspection-ready GxP actions — covering SDLC touchpoints, cloud/SaaS responsibilities, access control, and audit trail requirements.
Carolyn TroianoGood Clinical Practices (GCP) Audit and Inspection Readiness
Build GCP audit and inspection readiness — cover QMS, SOPs, documentation, internal audits, and personnel training to ensure compliant clinical trial execution.
Charles H. PaulFDA Registration, Listing & Facility Licensing — Common Pitfalls and Best Practices
Cut through recurring FDA registration, listing, and facility licensing errors — avoid misclassifications, missed updates, and common pitfalls under 21 CFR Part 807 and Part 820.
Meredith Crabtree