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Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR - 2025
Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..
Date : 21st August 2025
Time : This Event is Over
Duration : 75 Mins
Preparing a FDA 510(k) submission - What to Know in 2025
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 26th June 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
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
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
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
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
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)-
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
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
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
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
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
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
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
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