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Medical Devices

By Danielle DeLucy
Preparing And Investigating Oos/Oot Results In A Regulated Environment
Recorded Session

By Joy McElroy
Gaining And Re-Establishing Control Of Your Cleanroom
Recorded Session

By Jeff Kasoff
Best practices for purchasing and supplier controls in the medical device industry
Recorded Session

By Loren Gelber
FDA Regulations for Pharmaceutical Good Manufacturing Practice (GMP)
Recorded Session

By Charles H. Paul
Risk Assessment for Medical Devices
Recorded Session

By Jose Ignacio Mora
Test Method Validation to Verify your Device Performance
Recorded Session

By David R. Dills
FDAs Final Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List
Recorded Session

By Pamela Joslin
Understand CERT Findings and What Your Organization Should Be Monitoring
Recorded Session

By Ginette M. Collazo
Human Error Reduction in GMP Related Environments
Recorded Session

By José Mora
Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
Recorded Session

By José Mora
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Recorded Session

By Ginette M. Collazo
How to Write Procedures to Avoid Human Errors
Recorded Session

By Danielle DeLucy
Handling OOS Test Results and Completing Robust Investigations
Recorded Session

By Don Hurd
Risk Management Under ISO 14971 Integrating Concepts From IEC 62304 and ANSI 62366
Recorded Session

By Danielle DeLucy
Developing an Effective CAPA Management and Root Cause Analysis System
Recorded Session

By Danielle DeLucy
Proper Execution of Annual Product Reviews
Recorded Session

By Edwin Waldbusser
Software Validation for the New FDA Inspections
Recorded Session

By Danielle DeLucy
Implementing a Change Control Quality System Successfully
Recorded Session

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