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Medical Device Cybersecurity following September 2023 FDA Premarket Guidance
Overview: This webinar will cover FDA's evolving position on medical device cybersecurity. The..
Date : 29th November 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity
Overview: For over three decades, the FDA has regulated computer system validation in industr..
Date : 27th November 2023
Time : This Event is Over and the Recorded Content is Available
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FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance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
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
RISK MANAGEMENT FOR ML MEDICAL DEVICES FOLLOWING BS/AAMI 34971 AND ISO 14971
Overview:In the field of medical technology, the integration of Machine Learning (ML) within medic..
Date : 28th August 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
510K Submission Process for Medical Devices
Overview: There are three types of 510(k) submissions that can be submitted – Traditional, Spec..
Date : 25th August 2023
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 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
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
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
Functional and System Requirements for Systems Regulated by FDA - New Updates Included
Overview: Computer System Validation (CSV) has been regulated by FDA for more than 35 years, a..
Date : 28th June 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Medical Device Cybersecurity following 2022 FDA Premarket Guidance
Overview: In this informative webinar, we delve into the critical field of medical device cyb..
Date : 20th June 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Mastering Mobile App Validation in FDA-Regulated Environments
Overview: In this webinar, we will delve into the critical aspects of applying computer syste..
Date : 26th May 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 90 Mins
Excel Spreadsheet in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance
Overview:Join us for an interactive webinar that demystifies the process of configuring and valida..
Date : 22nd May 2023
Time : This Event Is Over
Duration : 90 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning - New FDA Guidance
Overview:Explore how AI/ML is transforming medicine by making diagnosis and treatment more accessibl..
Date : 27th April 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins