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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 : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance
Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and a..
Date : 19th November 2024
Time : This Event is Over
Duration : 75 Mins
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
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
Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA in 2024
Overview: The U.S. Food and Drug Administration (FDA) plays a critical role in safeguarding p..
Date : 30th August 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
Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024
Overview: In the world of medical device development, the US FDA places a high priority on ri..
Date : 14th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 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
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
Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance
Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..
Date : 25th June 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
10 Minutes excerpt from the recorded event for your review:Read the LinkedIn Article: LinkedIn ..
Date : 30th May 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
Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR-
Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..
Date : 21st March 2024
Time : This Event is Over
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
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)
Overview: As the life sciences industry, encompassing pharmaceuticals, medical devices, biote..
Date : 23rd February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins