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 Collazo
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. LincolnAI 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 CollazoAnnex 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
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 CollazoUsing 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 CrabtreeQuality 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 CrabtreeFDA 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 Mora
IQ, 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. LincolnOnboarding 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
FDA's 21 CFR Part 11 Add-On Inspections
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. LincolnBad 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 EspositoHow to Conduct Annual Product Reviews to Achieve GMP Compliance
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 DeLucyHuman Error Investigation Program — Effective Implementation
Implement a proven human error investigation methodology — classify error categories, identify root causes, develop effective CAPA, and apply Human Factors to prevent recurring GMP issues.
Dr. Ginette CollazoFDA Inspection Readiness: Building a Defensible State of Control Before the Investigator Arrives
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. PaulDeviation Backlog Reduction: Balancing Investigation Depth, Closure Speed, and Justifiable Decisions
Practical strategies for reducing pharmaceutical deviation backlogs without sacrificing investigation quality — covering risk-based depth, defensible closure, CAPA, and inspection readiness.
Charles H. PaulAI 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
Beyond Digital Batch Records: Managing FDA and EU GMP Documentation While Preserving Data Integrity
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. LincolnAseptic Processing and Contamination Control Under EU GMP Annex 1: Practical Applications for Modern Sterile Operations
Learn how to apply EU GMP Annex 1 contamination control principles in practice — covering CCS, environmental monitoring signals, aseptic interventions, and sterility assurance decisions.
Meredith CrabtreeMeasuring 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 EspositoUsing 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. PaulPackaging 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 EspositoOOS Investigations: Decision-Making in Practice and FDA Expectations for 2026
Learn how to interpret OOS results, recognize signals, and align investigation decisions with current FDA expectations under 21 CFR Part 211.
Meredith CrabtreeGMP 101 and Inspection Readiness
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. PaulContamination Prevention and Environmental Control
Build inspection-ready contamination control systems — cover cleanroom behavior, environmental monitoring, sanitation validation, and GMP expectations under 21 CFR 211.
Charles H. PaulDeviations, 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. PaulProcess Validation Requirements and Compliance Strategies
Recalibrate your process validation program — connect IQ/OQ/PQ to FDA and ISO frameworks and build robust, reliable processes that withstand regulatory scrutiny.
José MoraHuman Behavior Under FDA Scrutiny: How Words, Actions, and Reactions Shape Inspection Outcomes
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. PaulSuccessfully Investigating Deviations
Master the fundamental steps of deviation investigation — use objective evidence to determine root cause, develop effective CAPA, and avoid FDA 483 observations.
Danielle DeLucy