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Learn from the Best

Our Expert Instructors

World-class practitioners sharing real-world knowledge, not just theory.

Dr. Ginette Collazo

Dr. Ginette Collazo

Industrial-Organizational Psychologist & GMP Human Performance Expert

20+ Years Industrial-Org PsychologyFounder & CEO, Human Error Solutions
Carolyn Troiano

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

45+ Years CSV Experience21 CFR Part 11 Co-Developer
Dr. John C. Fetzer

Dr. John C. Fetzer

HPLC Method Development Expert & GLP Compliance Specialist

PhD Chromatography50+ Published Papers
Charles H. Paul

Charles H. Paul

President, CHP Consulting LLC — Regulatory Compliance & Operational Excellence

30+ Years Regulatory ConsultingAdvanced Therapy GMP Specialist
Meredith Crabtree

Meredith Crabtree

GMP Quality Consultant & Validation Specialist

30+ Years GMP ExperienceIQ/OQ/PQ Specialist
John E. Lincoln

John E. Lincoln

FDA Regulatory Affairs, Design Control & QMS Expert

40+ Years FDA Regulated Industries30 Years Independent Consultant
David Nettleton

David Nettleton

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

21 CFR Part 11 Specialist185+ Validation Projects
José Mora

José Mora

Medical Device Quality Systems & Configuration Management Consultant

30+ Years Medical Device IndustryBoston Scientific & Stryker Alumnus
Danielle DeLucy

Danielle DeLucy

Pharmaceutical Quality & Microbiology Consultant

MS Microbiology15+ Years QA/QC Leadership
Michael Esposito

Michael Esposito

GMP Training & Document Management Specialist

30 Years Pharmaceutical IndustryPfizer & J&J Alumni
Alan M. Golden

Alan M. Golden

FDA Regulatory & Compliance Consultant

FDA Regulatory ExpertGMP Compliance Specialist
G. Sundar

G. Sundar

Director & Senior Consultant, PharmQA Compliance Services

35 Years Quality Experience200+ GMP/GLP Audits

Previously Aired

Past Webinars

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510(k)s, DeNovos, and PMA Submissions: Practical Considerations for Modern Device Classifications and Market Authorization
Past WebinarNew
Regulatory & ComplianceCertificate

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.

1.5 hoursNov 4, 2026
4.5
from$290.00
Ended
View Details
GCP E6(R3): What Inspectors Will Test in Sponsor Oversight
Past WebinarNew
Regulatory & ComplianceCertificate

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.

1.5 hoursNov 4, 2026
4.5
from$290.00
Ended
View Details
Risk Based Quality Management and Risk Based Monitoring under ICH E6 (R3)
Past WebinarNew
Regulatory & ComplianceCertificate

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).

Nelle Stocquart
1 hourNov 3, 2026
4.5
from$340.00
Ended
View Details
From Inspection Observation to 483 Response: Evidence Triage, Immediate Corrections and Commitments You Should Not Make
Past WebinarNew
Regulatory & ComplianceCertificate

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.

1.5 hoursOct 29, 2026
4.5
from$290.00
Ended
View Details
Cleaning Validation Lifecycle Control: Monitoring Drift, Method Sensitivity, and Revalidation Decisions
Past WebinarNew
Regulatory & ComplianceCertificate

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.

Meredith CrabtreeMeredith Crabtree
1.5 hoursOct 29, 2026
4.5
from$290.00
Ended
View Details
Change Control for SaaS and AI Systems: Managing Configuration Drift and Revalidation Without Creating Validation Backlogs
Past WebinarNew

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