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Medical Devices

Live Webinars
Chronicles

By Carolyn Troiano

COTS, Cloud, and SaaS Systems and FDA Validation Compliance

Date: Aug. 18, 2025

By Alan M Golden

Impact Assessments For Supplier Change Notices

Recorded Session

By Alan M Golden

Validation Sampling Plans

Recorded Session

By Charles H. Paul

Project Management for Non-Project Managers - Scheduling your Project

Recorded Session

By Charles H. Paul

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

Recorded Session

By Danielle DeLucy

Batch Record Review and Product Release

Recorded Session

By Charles H. Paul

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

Recorded Session

By Danielle DeLucy

Sunshine Act Reporting - Clarification for Clinical Research

Recorded Session

By Ginette M. Collazo

Human Error Reduction Techniques for Floor Supervisors

Recorded Session

By Jose Ignacio Mora

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

Recorded Session

By Ginette M. Collazo

How to Write Procedures to Avoid Human Errors

Recorded Session

By Shini Menon

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

Recorded Session

By Alan M Golden

Validation Statistics for Non-Statisticians

Recorded Session

By Alan M Golden

Design Control for Medical Devices and Combination Products

Recorded Session

By Charles H. Paul

Risk Analysis in the Medical Device Design Process

Recorded Session

By Danielle DeLucy

Successful Supplier Audits

Recorded Session

By Edwin Waldbusser

Medical Device Hazard analysis following ISO 14971

Recorded Session

By Charles H. Paul

Risk Assessment for Medical Devices

Recorded Session

By Charles H. Paul

Project Management for Non-Project Managers

Recorded Session

By Danielle DeLucy

Implementing a Change Control Quality System Successfully

Recorded Session

By Ginette M. Collazo

Human Error Reduction in GMP Related Environments

Recorded Session

By Ginette M. Collazo

Human Error Reduction in GMP Manufacturing Environments for Floor Supervisors

Recorded Session

By Jose Ignacio Mora

Medical Device Software Per IEC 62304

Recorded Session

By Edwin Waldbusser

Software Validation for the New FDA Inspections

Recorded Session

By Danielle DeLucy

Proper Execution of Annual Product Reviews

Recorded Session

By Danielle DeLucy

Developing an Effective CAPA Management and Root Cause Analysis System

Recorded Session

By Don Hurd

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

Recorded Session

By Jose Ignacio Mora

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

Recorded Session

By Pamela Joslin

Understand CERT Findings and What Your Organization Should Be Monitoring

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 Loren Gelber

FDA Regulations for Pharmaceutical Good Manufacturing Practice (GMP)

Recorded Session

By Jeff Kasoff

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

Recorded Session

By Joy McElroy

Gaining And Re-Establishing Control Of Your Cleanroom

Recorded Session

By Danielle DeLucy

Preparing And Investigating Oos/Oot Results In A Regulated Environment

Recorded Session

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