Upcoming Webinar
Functional and System Requirements for Systems Regulated by FDA in 2024
Overview: The validation of computer systems (CSV) under FDA regulations has shaped the way e..
Date : 25th November 2024
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins
José Mora
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Overview: Test Method Validation (TMV) is a critical yet often misunderstood requirement in t..
Date : 21st October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
An Advanced Course on Lean Documents, Lean Configuration, and Document Control in 2024
Overview: In today's fast-paced life sciences industry, many companies struggle with cumberso..
Date : 20th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Overview: 21 CFR Part 820 delineates the Quality System Regulation (QSR) that governs all ent..
Date : 23rd July 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
How to Conduct a Human Factors Usability Validation for Medical Device Products
Course Level: IntermediateOverview:Human Factors/ Usability is the analysis of how people interact ..
Date : 08th Feb 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
An Advanced Course on Lean Documents, Lean Configuration, and Document Control
Overview:Just as a manufacturing process produces a product, controlled documents are the product o..
Date : 13th July 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 1 Hour 30 Mins
Risk-based Design Control - The New Paradigm for Medical Device Design
Overview: Risk management overarches projects associated with a particular product family, giv..
Date : 17th February 2022
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 10 Mins
21 CFR Part 820 - Quality System - Principles of Lean Documents and Lean Configuration
Overview: All life science businesses are required to maintain their Quality Management Syste..
Date : 21st September 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 30 Mins
Risk Management for Medical Devices per ISO 14971:2019
Overview: Risk management overarches projects associated with a particular product family, gi..
Date : 11th August 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 19 Mins
Software Validation Utilizing Principles of Lean Documents and Lean Configuration
Overview: All life science businesses are required to maintain their Quality Management System..
Date : 10th June 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 90 Mins
IEC 62304 for Medical Device Software - Is your Medical Device Software Out of Compliance?
Overview:This course is essential for Medical Device companies interested in submitting software e..
Date : 23rd March 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 70 Mins