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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
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
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
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
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
Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR-
Overview: In today's rapidly evolving life sciences landscape, ensuring data integrity and pr..
Date : 21st March 2024
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, biote..
Date : 23rd February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
FDA Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations
Overview: Companies engaged in human clinical trials must comply with specific regulatory requ..
Date : 01st 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
FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance
Overview: Artificial Intelligence (AI) and Machine Learning (ML) are fast becoming game-change..
Date : 24th October 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Excel Spreadsheet in FDA Regulated Environment in 2023
Overview:The use of Excel in FDA-regulated environments goes beyond typical data organization and an..
Date : 28th September 2023
Time : This Event is Over
Duration : 90 Mins
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