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Medical Devices Speaker

Human Error Reduction Techniques for Floor Supervisors

Speaker: Ginette M. Collazo

Duration: 90 Minutes

Recorded Session

Medical Devices Speaker

COTS, Cloud, and SaaS Systems and FDA Validation Compliance

Speaker: Carolyn Troiano

Duration: 90 Minutes

Recorded Session

Medical Devices Speaker

Impact Assessments For Supplier Change Notices

Speaker: Alan M Golden

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Validation Sampling Plans

Speaker: Alan M Golden

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Project Management for Non-Project Managers - Scheduling your Project

Speaker: Charles H. Paul

Duration: 90 Minutes

Recorded Session

Medical Devices Speaker

Batch Record Review and Product Release

Speaker: Danielle DeLucy

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

FDA Audit Best Practices - Do's and Don'ts

Speaker: Charles H. Paul

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Sunshine Act Reporting - Clarification for Clinical Research

Speaker: Danielle DeLucy

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration

Speaker: Jose Ignacio Mora

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

How to Write Procedures to Avoid Human Errors

Speaker: Ginette M. Collazo

Duration: 90 Minutes

Recorded Session

Medical Devices Speaker

Impact of machine learning in pre-clinical research and regulatory compliance

Speaker: Shini Menon

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Validation Statistics for Non-Statisticians

Speaker: Alan M Golden

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Design Control for Medical Devices and Combination Products

Speaker: Alan M Golden

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Risk Analysis in the Medical Device Design Process

Speaker: Charles H. Paul

Duration: 90 Minutes

Recorded Session

Medical Devices Speaker

Successful Supplier Audits

Speaker: Danielle DeLucy

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Medical Device Hazard analysis following ISO 14971

Speaker: Edwin Waldbusser

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Risk Assessment for Medical Devices

Speaker: Charles H. Paul

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Project Management for Non-Project Managers

Speaker: Charles H. Paul

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Implementing a Change Control Quality System Successfully

Speaker: Danielle DeLucy

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Human Error Reduction in GMP Related Environments

Speaker: Ginette M. Collazo

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Human Error Reduction in GMP Manufacturing Environments for Floor Supervisors

Speaker: Ginette M. Collazo

Duration: 90 Minutes

Recorded Session

Medical Devices Speaker

Medical Device Software Per IEC 62304

Speaker: Jose Ignacio Mora

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Software Validation for the New FDA Inspections

Speaker: Edwin Waldbusser

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Proper Execution of Annual Product Reviews

Speaker: Danielle DeLucy

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Developing an Effective CAPA Management and Root Cause Analysis System

Speaker: Danielle DeLucy

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Risk Management Under ISO 14971 Integrating Concepts From IEC 62304 and ANSI 62366

Speaker: Don Hurd

Duration: 75 Minutes

Recorded Session

Medical Devices Speaker

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

Speaker: Jose Ignacio Mora

Duration: 90 Minutes

Recorded Session

Medical Devices Speaker

Understand CERT Findings and What Your Organization Should Be Monitoring

Speaker: Pamela Joslin

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

FDAs Final Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List

Speaker: David R. Dills

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

FDA Regulations for Pharmaceutical Good Manufacturing Practice (GMP)

Speaker: Loren Gelber

Duration: 90 Minutes

Recorded Session

Medical Devices Speaker

Best practices for purchasing and supplier controls in the medical device industry

Speaker: Jeff Kasoff

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Gaining And Re-Establishing Control Of Your Cleanroom

Speaker: Joy McElroy

Duration: 60 Minutes

Recorded Session

Medical Devices Speaker

Preparing And Investigating Oos/Oot Results In A Regulated Environment

Speaker: Danielle DeLucy

Duration: 60 Minutes

Recorded Session

Medical Devices

Project Management for Non-Project Managers - How to communicate project actions and progress - conducting effective project review meetings

Human Error Reduction Techniques for Floor Supervisors

COTS, Cloud, and SaaS Systems and FDA Validation Compliance

Impact Assessments For Supplier Change Notices

Validation Sampling Plans

Project Management for Non-Project Managers - Scheduling your Project

Batch Record Review and Product Release

FDA Audit Best Practices - Do's and Don'ts

Sunshine Act Reporting - Clarification for Clinical Research

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) – Principles on Lean Documents and Lean Configuration

How to Write Procedures to Avoid Human Errors

Impact of machine learning in pre-clinical research and regulatory compliance

Validation Statistics for Non-Statisticians

Design Control for Medical Devices and Combination Products

Risk Analysis in the Medical Device Design Process

Successful Supplier Audits

Medical Device Hazard analysis following ISO 14971

Risk Assessment for Medical Devices

Project Management for Non-Project Managers

Implementing a Change Control Quality System Successfully

Human Error Reduction in GMP Related Environments

Human Error Reduction in GMP Manufacturing Environments for Floor Supervisors

Medical Device Software Per IEC 62304

Software Validation for the New FDA Inspections

Proper Execution of Annual Product Reviews

Developing an Effective CAPA Management and Root Cause Analysis System

Risk Management Under ISO 14971 Integrating Concepts From IEC 62304 and ANSI 62366

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

Understand CERT Findings and What Your Organization Should Be Monitoring

FDAs Final Rule Regarding Device Establishment Registration and Listing: Procedure on How to Register and List

FDA Regulations for Pharmaceutical Good Manufacturing Practice (GMP)

Best practices for purchasing and supplier controls in the medical device industry

Gaining And Re-Establishing Control Of Your Cleanroom

Preparing And Investigating Oos/Oot Results In A Regulated Environment

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