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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
Excel Spreadsheet in FDA Regulated Environment in 2023
Overview:The use of Excel in FDA-regulated environments goes beyond typical data organization and ..
Date : 27th July 2023
Time : This Event is Over
Duration : 90 Mins
Mastering Mobile App Validation in FDA-Regulated Environments
Overview: In this webinar, we will delve into the critical aspects of applying computer syste..
Date : 26th May 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Good Documentation Practices to Support FDA Computer System Validation
Overview: Computer system validation has been regulated by FDA for more than 30 years, as it ..
Date : 29th March 2023
Time : This Event is Over and the Recorded Content is Available
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
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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time
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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 60 Mins