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

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

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

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

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

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

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

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

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

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

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