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Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

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)

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

Best Practices in Preparation for an FDA Computer System Audit in 2023

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

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

Good Documentation Practices to Support FDA Computer System Validation

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

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

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 : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

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