Search

Products meeting the search criteria

The 6 Most Common Problems in FDA Software Validation and Verification in 2025

The 6 Most Common Problems in FDA Software Validation and Verification in 2025

Overview: Professionals working with FDA-regulated software face numerous challenges when it co..

Date : 12th June 2025

Time : This Event is Over

Duration : 75 Mins

FDA Human Factors Usability Guidance | ISO 62366 & Draft Update Explained

FDA Human Factors Usability Guidance | ISO 62366 & Draft Update Explained

Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..

Date : 29th May 2025

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

Duration : 75 Minutes

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

Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2025

Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2025

Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and a..

Date : 11th April 2025

Time : This Event is Over

Duration : 90 Mins

Best Practices for Creating a Clear-Cut Contract and Service Level Agreement (SLA) with a Vendor of Computer Systems Regulated by FDA

Best Practices for Creating a Clear-Cut Contract and Service Level Agreement (SLA) with a Vendor of Computer Systems Regulated by FDA

Overview: Selecting and managing a vendor for computer systems in FDA-regulated environments ..

Date : February 26, 2025

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

Duration : 90 Mins

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2025

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2025

Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and priv..

Date : 14th February 2025

Time : This Event is Over

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, biotech..

Date : 13th January 2025

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

Duration : 90 Mins + Q&A

Functional and System Requirements for Systems Regulated by FDA in 2024

Functional and System Requirements for Systems Regulated by FDA in 2024

Overview: The validation of computer systems (CSV) under FDA regulations has shaped the way e..

Date : 25th November 2024

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

Duration : 90 Mins

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

Showing 1 to 15 of 33 (3 Pages)