Carolyn Troiano


Pharma 4.0 - Overcoming Data Integrity Issues in the Cloud to Meet FDA Compliance Requirements

Pharma 4.0 - Overcoming Data Integrity Issues in the Cloud to Meet FDA Compliance Requirements

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

Date : 31st August 2022

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

Duration : 1 Hour 40 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 re..

Date : 27th July 2022

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

Duration : 1 Hour 40 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 : 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

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

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

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

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

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

GAMP®5, 2nd Edition & FDA's CSA Guidance - Aligning Validation Practices

Overview The landscape of computer system validation is undergoing a transformative shift wit..

Date : 30th April 2024

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

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