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Milan Kučera · 1.5 hours
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Our Expert Instructors
World-class practitioners sharing real-world knowledge, not just theory.

Dr. Ginette Collazo
Industrial-Organizational Psychologist & GMP Human Performance Expert

Carolyn Troiano
FDA Compliance & Computer System Validation Consultant

Dr. John C. Fetzer
HPLC Method Development Expert & GLP Compliance Specialist

Charles H. Paul
President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence

Meredith Crabtree
GMP Quality Consultant & Validation Specialist

John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert

David Nettleton
FDA Compliance Specialist — 21 CFR Part 11 & Computer System Validation

José Mora
Medical Device Quality Systems & Configuration Management Consultant
Danielle DeLucy
Pharmaceutical Quality & Microbiology Consultant

Michael Esposito
GMP Training & Document Management Specialist

Alan M. Golden
FDA Regulatory & Compliance Consultant

G. Sundar
Director & Senior Consultant, PharmQA Compliance Services
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Past Webinars
510(k)s, DeNovos, and PMA Submissions: Practical Considerations for Modern Device Classifications and Market Authorization
This course helps device teams distinguish among FDA submission pathways and evaluate how classification, risk, clinical evidence, newer technologies, and available submission programs affect regulatory planning and market authorization.
GCP E6(R3): What Inspectors Will Test in Sponsor Oversight
This course helps sponsors establish a clearer oversight strategy, align supplier arrangements with ICH-GCP E6(R3), and prepare documentation and contractual evidence that supports inspection readiness.
Risk Based Quality Management and Risk Based Monitoring under ICH E6 (R3)
This course helps clinical trial teams distinguish RBQM from RBM, identify Critical to Quality factors, and establish a practical implementation approach aligned with ICH E8(R1) and ICH E6(R3).
From Inspection Observation to 483 Response: Evidence Triage, Immediate Corrections and Commitments You Should Not Make
This course strengthens the ability to control the critical period between an emerging FDA inspection concern and the formal response, using available evidence to prioritize actions and make commitments that remain supportable after the inspection ends.
Cleaning Validation Lifecycle Control: Monitoring Drift, Method Sensitivity, and Revalidation Decisions
This session examines cleaning validation from a lifecycle perspective, focusing on how organizations maintain confidence in validated cleaning processes long after initial approval.
Change Control for SaaS and AI Systems: Managing Configuration Drift and Revalidation Without Creating Validation Backlogs
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