Upcoming Events
29 events scheduledThe First FDA Warning Letter on AI: What It Means for Your Quality System
Understand how FDA enforcement actions on AI are reshaping compliance expectations and what your organization must do to stay inspection-ready.
Reclassification of Software Automated Medical Devices
Navigate FDA, EMA, and global classification frameworks for software-driven medical devices — from AI-powered diagnostics to autonomous delivery systems.
Digital Quality Metrics and AI/ML Analytics: Building a Continuous-Improvement Framework
Harness real-time digital quality signals and AI/ML analytics to boost compliance, detect deviations early, and align with FDA regulatory expectations.
ChatGPT-Assisted Technical Writing
A practical, compliance-aligned framework for using ChatGPT as a controlled writing tool in regulated industries — boosting productivity without compromising data integrity.
GMP Laboratory Data Integrity in 2026: Practical Strategies for FDA and MHRA Inspection Readiness
Go beyond procedural compliance — learn how FDA and MHRA investigators evaluate laboratory oversight maturity and build defensible data integrity practices.
Excel Spreadsheets – Ensuring Data Integrity and 21 CFR Part 11 Compliance
Configure and validate GxP compliant Excel applications step-by-step — audit trails, security features, and data verification — no macros required.
HPLC Analytical Method Development and Validation
Master instrument and method validation for liquid chromatography — meeting US EPA and FDA requirements to ensure every result is usable, reportable, and audit-ready.
Supplier and Contract Manufacturer Management Course
A comprehensive 2-day program covering the full supplier lifecycle — qualification, risk assessment, quality agreements, performance monitoring, and supplier exits.
RCA & CAPA: What Inspectors Look For Beyond a "Well-Documented" Investigation
Move beyond paperwork compliance — build investigations that connect triggers to true root causes and CAPAs that hold up under FDA inspection scrutiny. 4 Modules.
AI Errors May Be Impossible to Eliminate – What That Means for Its Use in the FDA
Understand the irreducible error rates in AI systems and what FDA expects organizations to do about them before deploying AI in regulated environments.
AI in GMP: What the FDA Is Already Expecting — Before You Ask
Stay ahead of FDA's evolving AI expectations in GMP environments — before guidance is finalized and before your next inspection.
QMSR Device Records: Structuring DDF, MDF and Related Relationships for Inspection Readiness
Move beyond document-centric compliance — learn how to structure device records as an interconnected system of relationships that holds up under FDA inspection scrutiny.
AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to Defend
Examine the practical realities of AI-assisted PMS while maintaining defensible regulatory oversight — signal evaluation, MDR reporting, and the human judgment regulators will still require.
IQ, OQ & PQ in 2026: What Now Counts as Sufficient Validation Evidence
Understand what modern regulators actually evaluate in IQ, OQ, PQ, and PPQ activities — and how to produce defensible, risk-based validation evidence that goes beyond documentation volume.
Root Cause Analysis for GMP Investigations: Identifying Systemic Failures and Building Effective CAPA
Master a repeatable, closed-loop failure investigation methodology — using flow charts, the 5 Whys, and 7 powerful tools to resolve root problems and build CAPA that holds up under FDA inspection.
Pharma 4.0 Focus: Data Integrity by Design — Newer Approaches & Cost-Effective 21 CFR Part 11 Compliance
Explore the Pharma 4.0 operating model and modern validation technologies to build inspection-ready data integrity programs that reduce cost and complexity.
Data Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR
Get precise clarity on what Part 11, Annex 11, and EU GDPR actually require — covering local and cloud environments, AI software validation, electronic signatures, and fill-in-the-blank templates.
Deviation Backlog Reduction: Balancing Investigation Depth, Closure Speed, and Justifiable Decisions
Learn practical strategies to reduce deviation backlogs without sacrificing investigation quality or regulatory defensibility — and build sustainable systems to prevent future accumulation.
Annex 22 and AI Governance for GMP: Human Review, Model Monitoring, and Change Control
Meet EU Annex 22 requirements while harnessing AI, ML, and LLMs with the critical human oversight needed for quality, compliance, and ROI in FDA-regulated environments.
Advanced Therapy GMP Release and Chain-of-Identity Controls
Master the GMP release systems, chain-of-identity controls, and traceability frameworks required to protect patient safety and maintain regulatory compliance in advanced therapy manufacturing.
OTC Monograph Reform and OMUFA II: What FDA's Modernized OTC Framework Means for Manufacturers
Navigate the practical regulatory, quality, and operational implications of FDA's modernized OTC monograph system and OMUFA II — from product lifecycle decisions to documentation requirements.
OOS Investigations: Decision-Making in Practice and FDA Expectations for 2026
Learn how to interpret OOS results clearly, recognize investigation gaps, and align every decision with current FDA expectations for 2026.
AI for CAPA and Investigations: Where It Helps and Where It Can Get You in Trouble
Understand where AI genuinely improves efficiency in CAPA workflows — and where it creates hidden regulatory risk in root cause analysis and investigation defensibility.
Nitrosamines After the Initial Assessment: When Does a Change Trigger Reassessment and How Should Impact Be Evaluated
A technical deep-dive into post-approval nitrosamine reassessment triggers, ICH M7 purge justifications, NDSRI/CPCA classification, and control strategy selection across FDA, EMA, and global frameworks.
Beyond Digital Batch Records: Managing FDA and EU GMP Documentation While Preserving Data Integrity
A practical compliance session on 21 CFR Part 11, EU GMP Annex 11, ALCOA+ principles, electronic signatures, hybrid documentation systems, and inspection-readiness for digital records environments.
Aseptic Processing and Contamination Control Under EU GMP Annex 1: Practical Applications for Modern Sterile Operations
Translate Annex 1 contamination control expectations into practical sterile manufacturing decisions — CCS design, environmental monitoring interpretation, intervention management, and sterility assurance rationale.
Acceptance Criteria for AI Validation: Determining What “Reliable” Actually Means in GxP Systems
Move beyond checkbox validation — define measurable, risk-based acceptance criteria for AI-enabled GxP systems aligned with FDA, EMA, MHRA, GAMP®, and data integrity expectations.
Audit Trail Review by Exception: Reducing Reviewer Burden Without Weakening Detection
Implement a risk-based review-by-exception strategy that cuts reviewer fatigue and speeds batch release while strengthening detection of data integrity, compliance, and cybersecurity risks.
Measuring SOP Effectiveness Across Training, Qualification, GMP Operations, and AI-assisted Environments
Learn the vital connection between documentation, compliance, and training — and how to leverage SOPs to measure and improve training effectiveness, job performance, and quality outcomes.
Analytical Lifecycle Management Under ICH Q14 and Q2(R2): What Changes Operationally
Examines the operational impact of ICH Q14 and Q2(R2) beyond the guidance language — method flexibility, analytical control strategies, post-validation changes, and the evidence needed to sustain method performance throughout the product lifecycle.
Maintaining Traceability Between User Requirements, Risk Controls and Verification Evidence
Treat traceability as an observable property of a trustworthy product configuration — maintaining configured information and its relationships so traceability is produced, not reconstructed, as products evolve under QMSR and ISO 13485:2016.
EU MDR Technical Documentation: Keeping Risk, Clinical and Design Records Consistent Through Product Changes
A configuration-centered approach to assessing product changes across connected technical documentation — identifying where design modifications affect risk, clinical conclusions, verification evidence, and the regulatory record before inconsistencies become embedded.
Using SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions
Practical guidance on CGMP production controls using SPC, Six Sigma, and statistical methods — control charts, sampling plan justification, verification and validation evidence, and trending of NCMRs, complaints, and CAPAs.
Risk-Based CSV/CSA for Modern GxP Systems: Making Defensible Validation Decisions in Practice
A practical two-day framework for applying CSV, CSA, GAMP® 5, and quality risk management to cloud, SaaS, configurable, and AI-enabled GxP systems — with the emphasis on inspection readiness and regulatory-defensible decisions.
Design Changes After Clearance: When a New 510(k) Is Required
Evaluate post-clearance device changes consistently, determine when existing clearance remains supportable, and document the regulatory rationale behind decisions to submit — or not submit — a new 510(k).
Human-in-the-Loop (HITL) in GMP: Maintaining Human Oversight of AI-Assisted Decisions
Build meaningful human oversight of AI in GMP — defined decision authority, documented intervention, traceability, and lifecycle monitoring proportional to GMP risk.
Aseptic Process Simulations: Designing and Evaluating Media Fills
Design and evaluate media fills that meaningfully challenge aseptic operations, address contamination risks, support operator qualification, and show the process remains appropriately controlled.
Vendor Assurance for AI and Cloud-Based GxP Systems: What You Can Leverage, Challenge, and Independently Verify
A risk-based approach to vendor assurance that goes beyond certificates and questionnaires — deciding which vendor evidence to leverage, which claims to challenge, and which controls to independently verify.
Risk-Based Excel Spreadsheet Validation - 2026 Updates
A strategic, risk-based approach to validating Excel spreadsheets used in FDA-regulated activities — GAMP 5 categorization, SDLC validation, Part 11 compliance, and inspection readiness.
Software Validation Observations in FDA Warning Letters and Consent Decrees: Patterns, Root Causes, and Remediation Expectations
Recurring software validation deficiencies found in FDA warning letters and consent decrees — the organizational decisions behind them, and the remediation FDA ultimately expects.
Change Control for SaaS and AI Systems: Managing Configuration Drift and Revalidation Without Creating Validation Backlogs
A practical, risk-based framework for managing continuous SaaS and AI change while maintaining compliance, validated state, and inspection readiness — without a validation backlog.
Validating Interfaces Between GxP Systems: Data Transfers, APIs, Middleware, and Integration Failures
A risk-based approach to validating data transfers and system integrations — interface requirements, data mapping, transformation rules, error handling, reconciliation, monitoring, and end-to-end data integrity.
Risk Management for AI/ML Medical Devices: Applying ISO 14971 and ISO/TS 24971-2:2026
Put ML-specific risk guidance into practice — Product Hazard Analysis, FMEA and FTA for ML risks, risk controls and verification, and managing the risk file across the Total Product Life Cycle.
Repeat Deviations and OOS: Strengthening RCA-CAPA Effectiveness and Managing Investigation Backlogs
Risk-based decisions on when to investigate deeper, escalate, or close — recognizing systemic signals across deviations, OOS, and complaints, and why RCA so often fails to hold on repeat.