Event Catalog

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

Master HPLC instrument and method validation to meet US EPA and FDA requirements for pharmaceutical analysis.

Dr. John C. Fetzer

Understand what constitutes sufficient and defensible IQ, OQ, PQ, and PPQ validation evidence in modern GMP environments — with real-world examples.

Meredith Crabtree

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

John E. Lincoln

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

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

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 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

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

Master risk-based Excel spreadsheet validation for FDA-regulated environments — covering GAMP 5, SDLC, 21 CFR Part 11, data integrity, and inspection readiness.

Carolyn Troiano

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

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

Understand the latest global regulatory requirements for quality metrics and KPIs — learn to implement, align, and report metrics that satisfy FDA inspection scrutiny.

Meredith Crabtree

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 Troiano

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

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

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

Navigate FDA's increased scrutiny of electronic records and software validation — implement effective 21 CFR Part 11 V&V strategies aligned with GAMP, ISO 14971, and real-world inspection expectations.

John E. Lincoln

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

Learn how to write compliant Annual Product Quality Reviews (APRs) — covering regulatory requirements, what to include, and how well-written APRs strengthen your compliance position.

Danielle DeLucy

Master analytical method validation under GLP — covering statistical requirements, selectivity, stability assessment, reagent comparison, and FDA compliance for pharmaceutical laboratories.

Dr. John C. Fetzer

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

Understand how FDA selects inspection targets, evaluates quality systems remotely, and build a continuous state of control aligned with 21 CFR regulations before the investigator arrives.

Charles H. Paul

Apply SDLC, GAMP 5, and risk-based validation to Excel spreadsheets used in FDA-regulated activities — covering Part 11, data integrity, and inspection preparation.

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

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 digital/electronic DHF, DMR, DHR, and EU MDR Technical Documentation improves data integrity, reduces human error, and simplifies global regulatory compliance.

John E. Lincoln

Master the complex decisions that follow post-approval changes — when nitrosamine reassessment is mandatory, when scientific rationale suffices, and how to evaluate NDSRI impact using CPCA under ICH M7.

G. Sundar

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

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

Learn how to interpret OOS results, recognize signals, and align investigation decisions with current FDA expectations under 21 CFR Part 211.

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

Establish the mindset for modern GMP compliance — understand how FDA inspects, why documentation gaps become findings, and how to build inspection-ready systems.

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

Recalibrate your process validation program — connect IQ/OQ/PQ to FDA and ISO frameworks and build robust, reliable processes that withstand regulatory scrutiny.

José Mora

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

Carolyn Troiano

Manage FDA inspection close-out, Form 483 responses, CAPA commitments, and executive accountability to reduce enforcement risk and build long-term regulatory credibility.

Charles H. Paul

Understand how FDA investigators use behavior as evidence of system control — learn how verbal responses, role-based interactions, and behavioral triggers shape inspection outcomes.

Charles H. Paul

Master the fundamental steps of deviation investigation — use objective evidence to determine root cause, develop effective CAPA, and avoid FDA 483 observations.

Danielle DeLucy

Navigate FDA DHF, DMR, DHR, and EU MDR Technical Documentation requirements — understand the similarities, differences, and how to align global medical device documentation.

John E. Lincoln

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