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Medical Devices

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By Charles H. Paul
FDA Audit Best Practices - Do's and Don'ts
Date: April 30, 2024

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By Alan M Golden
Validation Statistics for Non-Statisticians
Date: May 10, 2024

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By Danielle DeLucy
Sunshine Act Reporting - Clarification for Clinical Research
Date: May 14, 2024

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By Alan M Golden
Validation Sampling Plans
Date: May 20, 2024

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

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

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

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

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

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

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

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

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

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By Danielle DeLucy
Proper Execution of Annual Product Reviews
Recorded Session

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

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By Jose Mora
Medical Device Software Per IEC 62304
Recorded Session

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By Ginette M. Collazo
Human Error Reduction in GMP Manufacturing Environments for Floor Supervisors
Recorded Session

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

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

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By Charles H. Paul
Project Management for Non-Project Managers
Recorded Session

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

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By Edwin Waldbusser
Medical Device Hazard analysis following ISO 14971
Recorded Session

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By Carolyn Troiano
GAMP5, Second Edition and Alignment with Computer Software Assurance (CSA) and Digital Validation
Recorded Session

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By Danielle DeLucy
Successful Supplier Audits
Recorded Session

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By Charles H. Paul
Risk Analysis in the Medical Device Design Process
Recorded Session

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By Alan M Golden
Design Control for Medical Devices and Combination Products
Recorded Session

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

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By Danielle DeLucy
Batch Record Review and Product Release
Recorded Session

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By Ginette M. Collazo
Human Error Reduction Techniques for Floor Supervisors
Recorded Session

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By Alan M Golden
Impact Assessments For Supplier Change Notices
Recorded Session

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