EU MDR Technical Documentation
Live Webinar EU MDR Technical Documentation Keeping Risk, Clinical and Design Records Consistent Through Product Changes DateSeptember 14, 2026 Time11 AM Eastern Time US | 3 PM GMT Duration90 Minutes Course DirectorJosé Ignacio Mora Register Now Key Areas Covered Product configuration as the basis for documentation consistency Change impact across design, materials, software, suppliers, and […]
Aseptic Process Simulations Designing and Evaluating Media Fills
Live Webinar Aseptic Process Simulations: Designing and Evaluating Media Fills DateSeptember 17, 2026 Time11 AM Eastern Time US | 3 PM GMT Duration60 Minutes Course DirectorDanielle DeLucy Register Now Key Areas Covered Selecting interventions and worst-case simulation conditions Setting media fill frequency and operator participation Growth media selection and filling line operating speeds Representing contamination […]
Maintaining Traceability
Live Webinar Maintaining Traceability Between User Requirements, Risk Controls and Verification Evidence DateSeptember 11, 2026 Time11 AM Eastern Time US | 3 PM GMT Duration90 Minutes Course DirectorJosé Ignacio Mora Register Now Key Areas Covered Traceability matrix versus maintained product configuration Requirements, risks, design outputs, and verification relationships Controlled states, revisions, applicability, and effectivity Identifying […]
SPC and Process Data FDB3755
Live Webinar Using SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions DateSeptember 09, 2026 Time11 AM Eastern Time US | 3 PM GMT Duration90 Minutes Course DirectorJohn E. Lincoln Register Now Key Areas Covered Statistical Process Control within regulated manufacturing Common cause versus special cause variation Control charts, process capability, and Cpk […]
Risk-Based CSV CSA FDB3244
2-Day Live Seminar Risk-Based CSV/CSA for Modern GxP Systems: Making Defensible Validation Decisions in Practice DatesSeptember 10 – 11, 2026 Course DirectorCarolyn Troiano Eastern Time US11 AM to 2 PM Time in GMT3 PM to 6 PM Register Now Key Areas Covered Risk-based determination of validation scope, testing depth, and evidence CSV and CSA application […]
Data Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR
Live Webinar Data Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR 2026 Updates DateSeptember 02, 2026 Time11 AM Eastern Time US | 3 PM GMT Duration75 Minutes Course DirectorDavid Nettleton Register Now Key Areas Covered Interpreting 21 CFR Part 11 requirements for AI and modern digital systems Mapping SOPs, system […]
Configuration Control Document Control
Live Webinar Configuration Control vs. Document Control Managing Design Changes Across Modern Quality Systems DateAugust 31, 2026 Time11 AM Eastern Time US | 3 PM GMT Duration90 Minutes Course DirectorJosé Ignacio Mora Register Now I’m Interested – Remind Me Key Areas Covered Configuration Control versus Document Control Configuration Architecture and the Single Source of Truth […]
Risk-based Excel Spreadsheet Validation
Live Webinar Risk-based Excel Spreadsheet Validation 2026 Updates DateSeptember 04, 2026 Time12 PM Eastern Time US | 4 PM GMT Duration90 Minutes Course DirectorCarolyn Troiano Register Now I’m Interested – Remind Me Key Areas Covered GxP spreadsheet identification and inventory management Risk assessment for determining validation scope CSV versus CSA approaches for spreadsheet assurance SDLC […]
Validating AI Use in Quality Systems
Live Webinar Validating AI Use in Quality Systems Practical CSV and CSA Approaches for FDA Inspection Readiness DateAugust 17, 2026 Time12 PM Eastern Time US | 4 PM GMT Duration90 Minutes Course DirectorCarolyn Troiano Register Now I’m Interested – Remind Me Key Areas Covered Limitations of traditional CSV for AI-assisted GxP systems Applying CSA principles […]
Human Error Trends as AI Enters GMP Operations
Live Webinar Human Error Trends as AI Enters GMP Operations: What QA Leaders Should Expect and Monitor DateAugust 26, 2026 Time11 AM Eastern Time US | 3 PM GMT Duration60 Minutes Course DirectorDr. Ginette Collazo Register Now Key Areas Covered Current FDA expectations for AI-enabled GMP operations AI governance and organizational accountability Validation and lifecycle […]