Upcoming Webinar

Functional and System Requirements for Systems Regulated by FDA in 2024

Functional and System Requirements for Systems Regulated by FDA in 2024

Overview: The validation of computer systems (CSV) under FDA regulations has shaped the way e..

Date : 25th November 2024

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

Duration : 90 Mins

Carolyn Troiano


Data Privacy: Navigating CPRA, HIPAA & GDPR Compliance Requirements for Industry

Data Privacy: Navigating CPRA, HIPAA & GDPR Compliance Requirements for Industry

Overview: The California Privacy Rights Act (CPRA) passed by voters in 2020 came into effect ..

Date : 21st April 2023

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

Duration : 90 Mins

Good Documentation Practices to Support FDA Computer System Validation

Good Documentation Practices to Support FDA Computer System Validation

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

Date : 29th March 2023

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

Duration : 90 Mins

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

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

Date : 23rd February 2023

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

Duration : 90 Mins

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

Overview: FDA has substantial authority to oversee regulated companies and their operations.&n..

Date : 30th November 2022

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

Duration : 90 Mins

Clinical Trial Master File (TMF) and electronic Clinical Trial Master File (eTMF) and FDA Compliance

Clinical Trial Master File (TMF) and electronic Clinical Trial Master File (eTMF) and FDA Compliance

Overview: Companies engaged in the conduct of human clinical trials must adhere to specific g..

Date : 28th October 2022

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

Duration : 90 Mins

Data Integrity and Governance for Computer Systems Regulated by FDA

Data Integrity and Governance for Computer Systems Regulated by FDA

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

Date : 27th September 2022

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

Duration : 90 Mins

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

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