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 📅 […]
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 […]
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 […]
Analytical Lifecycle Management 1616
The Leader in Quality Life Science Training Live Webinar Analytical Lifecycle Management Under ICH Q14 and Q2(R2): What Changes Operationally Clarifies how analytical lifecycle expectations affect development rationale, validation strategy, method change decisions, transfer activities, and continued performance monitoring. ♟ Faculty Meredith Crabtree ▶ Format Live + Post-live Continued Access Session Details 📅 Date August […]
CPV Using Review-by-Exception 1614
The Leader in Quality Life Science Training Register Now Live Webinar Continued Process Verification (CPV): Using Review-by-Exception Approaches for Process Monitoring and Product Quality Clarifies how CPV teams use exception criteria, process trends, and quality evidence to decide when commercial manufacturing data requires action. Faculty: Meredith L. Crabtree Reserve Your Seat Session Details 📅 Date […]
Global eCTD Operations 3754
The Leader in Quality Life Science Training Register Now Live Webinar Global eCTD v3.2.2 and eCTD v4.0 Operations: Managing FDA and EU Submissions Complexity Across the Product Lifecycle A practical session on CTD organization, eCTD version movement, and submission lifecycle control for teams managing FDA and EU regulatory files. Faculty: John E. Lincoln Reserve Your […]
QMSR Device Records DDF MDF 1382
The Leader in Quality Life Science Training Register Now Live Webinar QMSR Device Records: Structuring DDF, MDF and Related Relationships for Inspection Readiness A practical session on structuring device record relationships across design, risk, manufacturing, validation, change impact, and inspection evidence under QMSR expectations. Faculty: José Ignacio Mora Reserve Your Seat Session Details 📅 Date […]
Aseptic Processing and Contamination Control 1613
The Leader in Quality Life Science Training Register Now Live Webinar Aseptic Processing and Contamination Control Under EU GMP Annex 1: Practical Applications for Modern Sterile Operations Practical guidance for applying Annex 1 contamination control expectations to aseptic operations, monitoring signals, interventions, investigations, and sterility assurance decisions. Faculty: Meredith Crabtree Reserve Your Seat Session Details […]
EO Sterilization Validation and Revalidation 3753
The Leader in Quality Life Science Training Live Webinar EO Sterilization Validation and Revalidation Under ISO 11135: Practical Implementation and Lifecycle Considerations Practical guidance for qualifying EO sterilization processes, equipment, software controls, product loads, aeration, residuals, and periodic revalidation decisions. ♟ Faculty John E. Lincoln ▶ Format Live + Post-live Continued Access Session Details 📅 […]