Search

Products meeting the search criteria

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 Cybersecurity following September 2023 FDA Premarket Guidance

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

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FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance

FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance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

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

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

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

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

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

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

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

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

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

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

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

Showing 1 to 15 of 20 (2 Pages)