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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
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 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
Excel Spreadsheet in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2024
Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and a..
Date : 15th May 2024
Time : This Event is Over
Duration : 90 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-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems
Overview: For over three decades, the FDA has regulated computer system validation (CSV) acro..
Date : 25th March 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 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
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and..
Date : 29th January 2024
Time : This Event is Over
Duration : 90 Mins
Data Integrity and Data Governance for Computer Systems Regulated by FDA
Overview:Navigating the FDA's guidelines on computer system validation is no simple task, particul..
Date : 26th September 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Best Practices in Preparation for an FDA Computer System Audit in 2023
Overview:FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, ..
Date : 18th August 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
FDA Compliance and System Validation for Tobacco and Related Products
Overview:In this webinar, We will explore the significance of applying industry-best practices duri..
Date : 31st July 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins