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FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance
Overview: AI/ML is rapidly transforming the landscape of medicine, driving unprecedented chan..
Date : March 28, 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Effective Technical Writing for Medical Devices: Improving Your Skills for Clear and Concise Communication
Overview: In the world of medical device manufacturing, technical writing is more than just a..
Date : 27th March 2025
Time : This Event is Over and the Recorded Content is Available
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
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
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
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
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
Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA
Overview: Conducting human clinical trials requires strict adherence to government regulatory ..
Date : 30th October, 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Preparing a FDA 510(k) submission - What to Know in 2024
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 29th October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 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
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
Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024
Overview: In the world of medical device development, the US FDA places a high priority on ri..
Date : 14th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
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
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