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Data Integrity and Data Governance for Computer Systems Regulated by FDA in 2025

Data Integrity and Data Governance for Computer Systems Regulated by FDA in 2025

Overview: As regulatory scrutiny intensifies, data integrity and governance have become corne..

Date : 30th May 2025

Time : This Event is Over and the Recorded Content is Available

Duration : 75 Mins

Sampling Plans for Verification and Validation, Production Process Validation and Production Control

Sampling Plans for Verification and Validation, Production Process Validation and Production Control

Overview: When design flaws go unnoticed until late in production—or when a batch fails inspe..

Date : 23rd May 2025

Time : This Event is Over and the Recorded Content is Available

Duration : 60 Mins

US FDA Requirements for Medical Products Labeling / UDI

US FDA Requirements for Medical Products Labeling / UDI

Overview: The world of medical product labeling in the United States is governed by a complex ..

Date : 10th February 2025

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

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

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

The 6 Most Common Problems in FDA Software Validation and Verification in 2024

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

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 : 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

Preventing Human Error in the Life Sciences - Pharmaceutical and Medical Device

Preventing Human Error in the Life Sciences - Pharmaceutical and Medical Device

Overview: Human Error occurs in all settings.  In the world of pharmaceutical and medica..

Date : 29th July 2022

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

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