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FDA Compliance Training & Regulations

"FDA regulations related compliance training delivered by leading experts through webinars. This section contains compliance training for FDA regulated companies in areas - Audit and Inspection, Validation, 21 CFR Part 11, documentation, submission, Approvals, 510K, GxP , GMP,CGMP, CAPA , Packaging/labeling and Drug Marketing Compliance, Electronic Records, System Based Inspection, Documentation, Software validation."
 Sub Categories .
- FDA Audit and Inspection
- GXP Pharmaceutical
- GXP Medical Devices
- Drug and Device Approvals
- FDA Validation
- FDA 21 CFR Part 11
- Drug Marketing Compliance
.  Featured Courses . .
Best practices for creating a Risk Management File
Instructor : Dennis Moore  OnDemand Access Anytime  
FDA's new enforcement initiative – Strategic Software Validation Planning for Executives and Managers
Instructor : Alfonso Fuller  OnDemand Access Anytime  
How do I keep FDA happy with my contract manufacturer?
Instructor : Dennis Moore  OnDemand Access Anytime  
Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations
Instructor : John G Lanese  OnDemand Access Anytime  
Reducing Cleaning Validation Costs Using ICH Q9 and Recent FDA Guidance
Instructor : John Hyde  OnDemand Access Anytime  
U.S. FDA cGMP Compliance Audits -- Raising the Bar
Instructor : John E Lincoln  OnDemand Access Anytime  
Water System Compliance - Reducing Water Microbial Excursions and Improving Investigations
Instructor : T.C Soli  OnDemand Access Anytime  
Be Ready for UDI - The U.S. FDA's UDI Rule is Coming in 2010 - Know What's Ahead!
Instructor : John E Lincoln  OnDemand Access Anytime  
Effective Annual U.S. FDA CGMP Training
Instructor : John E Lincoln  OnDemand Access Anytime  
Effective Training Practices for FDA Compliance
Instructor : Dr. Ludwig Huber  OnDemand Access Anytime  
276 More | View All   
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Instructor in Focus

Bob Benoit
Bob Benoit is President and Director of SOX Research at Lord & Benoit, LLC, a national Sarbanes-Oxley Research and Compliance firm www.Section404.org. Bob has been teaching Compliance with Sarbanes-Oxley Section 404 throughout the U.S. through the State CPA Societies. He has been on Massachusetts AICPA Peer Review Acceptance Board for ten years. Bob's research has been quoted by three of the Big 4 CPA firms, PCAOB, SEC, SEC Staff, SEC Advisory Committee and AICPA-CPCAF.

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