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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

Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity

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

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

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

Excel Spreadsheet in FDA Regulated Environment in 2023

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

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

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

How to Conduct a Human Factors Usability Validation for Medical Device Products

How to Conduct a Human Factors Usability Validation for Medical Device Products

Course Level: IntermediateOverview:Human Factors/ Usability is the analysis of how people interact ..

Date : 08th Feb 2023

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

Duration : 60 Mins

Computer Software Assurance: Risk-Based Validation With Time-Saving Templates

Computer Software Assurance: Risk-Based Validation With Time-Saving Templates

Overview:This webinar describes exactly what is required for compliance with Part 11 and the Europe..

Date : 30th January 2023

Time : This Event is Over

Duration : 90 Mins

Medical Device Software Validation Meeting FDA Regulations

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

Excel Spreadsheets in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance

Excel Spreadsheets in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance

Overview: This interactive webinar explains how to configure and validate a GxP compliant sprea..

Date : 15th September 2022

Time : This Event is Over

Duration : 90 Mins

The 6 Most Common Problems in FDA Software Validation and Verification - What to Know?

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 Spreadsheets - Data Integrity and 21 CFR Part 11 Compliance

Excel Spreadsheets - Data Integrity and 21 CFR Part 11 Compliance

Overview: This interactive webinar explains how to configure and validate a GxP compliant sprea..

Date : 23rd June 2022

Time : This Event is Over

Duration : 90 Mins

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