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Live WebinarExcel Spreadsheets — Ensuring Data Integrity and 21 CFR Part 11 Compliance
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Excel Spreadsheets — Ensuring Data Integrity and 21 CFR Part 11 Compliance
Avoid FDA 483s by properly configuring and validating GxP-compliant Excel spreadsheets — with live step-by-step setup of audit trails, security features, and data entry verification.
David NettletonRegister Now
Upcoming Live Events
Excel Spreadsheets — Ensuring Data Integrity and 21 CFR Part 11 Compliance
Avoid FDA 483s by properly configuring and validating GxP-compliant Excel spreadsheets — with live step-by-step setup of audit trails, security features, and data entry verification.
$299.00
Human-in-the-Loop (HITL) in GMP: Maintaining Human Oversight of AI-Assisted Decisions
Human-in-the-Loop is not simply having a person present. Effective HITL requires meaningful human oversight, defined decision authority, documented intervention, traceability, and lifecycle monitoring proportional to GMP risk.
$290.00
Repeat Deviations and OOS: Strengthening RCA-CAPA Effectiveness and Managing Investigation Backlogs | Risk-Based Decisions on When to Investigate Deeper, Escalate, or Close
$290.00
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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
Data Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR
Get complete clarity on 21 CFR Part 11, Annex 11, SaaS/Cloud compliance, AI software validation, and EU GDPR requirements for regulated industries.
David NettletonRecording available
Determining Root Cause in Sterility Failure Investigations
A practical investigation framework for tracing sterility failures through laboratory, manufacturing, environmental, and contamination-source evidence to establish a defensible root cause, determine the impact on affected batches, and support appropriate corrective actions.
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.
Software Validation Observations in FDA Warning Letters and Consent Decrees: Patterns, Root Causes, and Remediation Expectations
Design Changes After Clearance: When a New 510(k) Is Required
Vendor Assurance for AI and Cloud-Based GxP Systems: What You Can Leverage, Challenge, and Independently Verify
A risk-based framework for vendor assurance of AI-enabled and cloud-based GxP systems: which vendor evidence you can leverage, which claims you must challenge, and which controls or outcomes you must independently verify.
Recording available
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