Event Catalog

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

This session examines complaint handling from a lifecycle perspective, focusing on how complaint information drives downstream quality and regulatory decisions.

Meredith Crabtree

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 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 Collazo

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.

Learn practical, compliant approaches to using ChatGPT for SOP drafting, document development, and technical writing in regulated industries.

Charles H. Paul

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. Lincoln

Master closed-loop CAPA with repeatable failure investigation and root cause analysis tools that satisfy FDA audit expectations in GMP environments.

John E. Lincoln

Get complete clarity on 21 CFR Part 11, Annex 11, SaaS/Cloud compliance, AI software validation, and EU GDPR requirements for regulated industries.

David Nettleton

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 Troiano

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 Troiano

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 Troiano

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

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

Understand the operational impact of ICH Q14 and Q2(R2) on analytical method development, validation, transfer, and lifecycle management in regulated pharmaceutical environments.

Meredith Crabtree

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

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

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

Understand the practical impact of FDA's modernized OTC monograph system and OMUFA II obligations on daily regulatory, quality, manufacturing, and compliance decisions.

Meredith Crabtree

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 Crabtree

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

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

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

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

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

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

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 Troiano

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. Lincoln

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

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 Troiano

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 Troiano

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. Paul

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

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 Mora

Master Drug Master File creation, submission, and lifecycle management — navigate FDA and EMA requirements, protect proprietary information, and maintain global regulatory compliance.

Charles H. Paul

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 Esposito

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. Lincoln

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 Troiano

A step-by-step guide to investigating sterility test failures — covering FDA regulations, root cause tools, lot impact assessment, and audit-ready documentation.

Danielle DeLucy

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. Paul

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 Troiano

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. Paul

Translate FDA cybersecurity expectations into inspection-ready GxP actions — covering SDLC touchpoints, cloud/SaaS responsibilities, access control, and audit trail requirements.

Carolyn Troiano

Build GCP audit and inspection readiness — cover QMS, SOPs, documentation, internal audits, and personnel training to ensure compliant clinical trial execution.

Charles H. Paul

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

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

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

Learn practical, compliant approaches to using ChatGPT for SOP drafting, document development, and technical writing in regulated industries.

Charles H. Paul

Master closed-loop CAPA with repeatable failure investigation and root cause analysis tools that satisfy FDA audit expectations in GMP environments.

John E. Lincoln

Get complete clarity on 21 CFR Part 11, Annex 11, SaaS/Cloud compliance, AI software validation, and EU GDPR requirements for regulated industries.

David Nettleton

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 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 Crabtree

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

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

A practical investigation framework for tracing sterility failures through laboratory, manufacturing, environmental, and contamination-source evidence to establish a defensible root cause, determine the impact on affected batches, and support appropriate corrective actions.

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.

Learn what FDA warning letters reveal about software validation, data integrity, audit trails, Part 11, CSV, CSA, change control and inspection readiness.

Meredith Crabtree

Learn how to manage SaaS updates, configuration drift, vendor releases and AI model changes using risk-based change control—without turning every update into a full revalidation project.

Carolyn Troiano

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

Understand the operational impact of ICH Q14 and Q2(R2) on analytical method development, validation, transfer, and lifecycle management in regulated pharmaceutical environments.

Meredith Crabtree

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 Crabtree

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

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

Understand the practical impact of FDA's modernized OTC monograph system and OMUFA II obligations on daily regulatory, quality, manufacturing, and compliance decisions.

Meredith Crabtree

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 Troiano

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

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 Troiano

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

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