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Best Practices in Preparation for an FDA Computer System Audit

Best Practices in Preparation for an FDA Computer System Audit

Overview: FDA requires that all computer systems used to produce, manage and report on “GxP” (G..

Date : 23rd June 2022

Time : This Event is Over and the Recorded Content is Available

Duration : 90 Mins

FDA Technology Modernization Action Plan and Impact on Regulated Computer Systems

FDA Technology Modernization Action Plan and Impact on Regulated Computer Systems

Overview: Computer system validation has been regulated by FDA for more than 30 years, as it re..

Date : 31st May 2022

Time : This Event is Over and the Recorded Content is Available

Duration : 1 Hour 30 Mins

FDA Regulation of Artificial Intelligence/ Machine Learning

FDA Regulation of Artificial Intelligence/ Machine Learning

Overview: AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible ..

Date : 25th May 2022

Time : This Event is Over and the Recorded Content is Available

Duration : 75 Mins

Preparing for an FDA Audit? Learn the Best Behavior Practices and the Do’s and Don’ts

Preparing for an FDA Audit? Learn the Best Behavior Practices and the Do’s and Don’ts

Overview: This webinar will begin by discussing and emphasizing the importance of truthfulness..

Date : 20th May 2022

Time : This Event is Over

Duration : 75 Mins

Functional and System Requirements for Systems Regulated by FDA

Functional and System Requirements for Systems Regulated by FDA

Overview:Computer System Validation (CSV) has been regulated by FDA for more than 35 years, as it r..

Date : 26th January 2022

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 50 Mins

FDA Compliance and Mobile Applications - What do you need to know?

FDA Compliance and Mobile Applications - What do you need to know?

Overview:This topic is focused on the use of mobile applications to process data regulated by FDA.&..

Date : 29th November 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 33 Mins

Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance

Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance

Overview: Human Factors/ Usability is the analysis of how people interact with medical devices..

Date : 28th October 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 15 Mins

Best Practices in Preparation for an FDA Computer System Audit

Best Practices in Preparation for an FDA Computer System Audit

Overview: FDA requires that all computer systems used to produce, manage and report on “GxP” (G..

Date : 30th September 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 55 Mins

FDA Regulation of Mobile medical apps and cybersecurity

FDA Regulation of Mobile medical apps and cybersecurity

Overview: This webinar will explain how to determine if your app is a medical device and if it..

Date : 24th August 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 60 Mins

Best Practices in Preparation for an FDA Computer System Audit - What You Need to Know?

Best Practices in Preparation for an FDA Computer System Audit - What You Need to Know?

Overview: FDA requires that all computer systems used to produce, manage and report on “GxP” ..

Date : 29th July 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 40 Mins

FDA Regulation of Artificial Intelligence/ Machine Learning - What You Need to Know?

FDA Regulation of Artificial Intelligence/ Machine Learning - What You Need to Know?

Overview: AI/ ML will revolutionize medicine by making diagnosis and treatment more accessibl..

Date : 30th June 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 60 Mins

In-Depth Testing of Computer Systems Regulated by FDA - What You Need to Know?

In-Depth Testing of Computer Systems Regulated by FDA - What You Need to Know?

Overview:This webinar will focus on testing as a key element of Computer System Validation (CSV). ..

Date : 28th May 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 24 Mins

FDA’s Technology Modernization Action Plan and Impact on Regulated Computer Systems and Data

FDA’s Technology Modernization Action Plan and Impact on Regulated Computer Systems and Data

Overview: Computer system validation has been regulated by FDA for more than 30 years, as it ..

Date : 28th April 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 40 Mins

Data Integrity and Governance for Computer Systems Regulated by FDA - What to Know

Data Integrity and Governance for Computer Systems Regulated by FDA - What to Know

Overview:The Webinar will focus on the importance of ensuring that the validation of an FDA-regula..

Date : 24th March 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 46 Mins

Cybersecurity for medical devices and the US FDA Compliance - What You Need to know

Cybersecurity for medical devices and the US FDA Compliance - What You Need to know

Overview:This webinar will focus on cybersecurity of medical devices, a key concern for those who ..

Date : 23rd February 2021

Time : This Event is Over and the Recorded Copy is Available

Duration : 1 Hour 37 Mins

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