Design Changes After Clearance 3756
The Leader in Quality Life Science Training Live Webinar Design Changes After Clearance: When a New 510(k) Is Required Assess post-clearance device modifications using FDA’s risk-based approach, supporting evidence, cumulative change impact, and documented rationale for the 510(k) submission decision. ♟ Faculty John E. Lincoln ▶ Format Live + Post-live Continued Access Session Details 📅 […]
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 […]
Nitrosamines 3537
The Leader in Quality Life Science Training 2-DAY LIVE TECHNICAL SEMINAR Nitrosamines After the Initial Assessment: When Does a Change Trigger Reassessment and How Should Impact Be Evaluated ♟ Faculty G. Sundar ▶ Format Live + Post-live Continued Access Session Details 📅 Dates September 10 – 11, 2026 🕙 Eastern Time (US/Canada) 11 AM to […]
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 […]
OOS Investigations 1414
The Leader in Quality Life Science Training Live Webinar OOS Investigations: Decision-Making in Practice and FDA Expectations for 2026 This session takes a closer look at how OOS investigations unfold in practice, from interpreting results, recognizing signals, and aligning investigation decisions with current FDA expectations. ♟ Faculty Meredith Crabtree ▶ Format Live + Post-live Continued […]
AI and Decision Making in GMP 1308
The Leader in Quality Life Science Training Live Webinar AI and Decision Making in GMP: Resolving Conflicts Between Human Judgment and AI Recommendations Structures how GMP teams assess conflicting human and AI conclusions, assign decision authority, escalate disagreements, and document the final rationale under regulatory oversight. ♟ Faculty Dr. Ginette Collazo, Ph.D. ▶ Format Live […]
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 […]