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Preparing a FDA 510(k) submission - What to Know in 2024
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 29th October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Best Practices in Preparation for an FDA Computer System Audit in 2024
10 Minutes excerpt from the recorded event for your review: Best Practices in Preparation for a..
Date : 22nd July 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
The 6 Most Common Problems in FDA Software Validation and Verification in 2024
Overview: Professionals working with FDA-regulated software face numerous challenges when it c..
Date : 18th July 2024
Time : This Event is Over
Duration : 75 Mins
Mastering Mobile App & Medical Device Software Validation and Cybersecurity in FDA-Regulated Environments
10 Minutes excerpt from the recorded event for your review: Read the LinkedIn Article: Lin..
Date : 28th June 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304
Overview: In the fast-evolving field of medical technology, ensuring the safety and efficacy ..
Date : 28th May 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices
Overview The landscape of computer system validation is undergoing a transformative shift wit..
Date : 30th April 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Risk Management for ML medical devices following BS/AAMI 34971:2023 and ISO 14971
Overview: FDA has always prioritized the risk management of medical devices, adhering to its ..
Date : 27th February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance
Overview: Artificial Intelligence (AI) and Machine Learning (ML) are fast becoming game-change..
Date : 24th October 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Medical Device Cybersecurity following 2022 FDA Premarket Guidance
Overview: In this informative webinar, we delve into the critical field of medical device cyb..
Date : 20th June 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Computer Software Assurance: Risk-Based Validation With Time-Saving Templates
Overview:This webinar describes exactly what is required for compliance with Part 11 and the Europe..
Date : 30th January 2023
Time : This Event is Over
Duration : 90 Mins
Medical Device Software Validation Meeting FDA Regulations
Overview: Testing software to prove that it works and has no bugs is not sufficient to obtain ..
Date : 25th October 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
The 6 Most Common Problems in FDA Software Validation and Verification - What to Know?
Overview:This webinar describes the validation planning process with particular emphasis on avoidin..
Date : 14th July 2022
Time : This Event is Over
Duration : 90 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
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