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Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2025

Excel Spreadsheet in FDA Regulated Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance in 2025

Overview:The use of Excel in FDA-regulated environments extends beyond basic data organization and a..

Date : 11th April 2025

Time : This Event is Over

Duration : 90 Mins

Best Practices for Creating a Clear-Cut Contract and Service Level Agreement (SLA) with a Vendor of Computer Systems Regulated by FDA

Best Practices for Creating a Clear-Cut Contract and Service Level Agreement (SLA) with a Vendor of Computer Systems Regulated by FDA

Overview: Selecting and managing a vendor for computer systems in FDA-regulated environments ..

Date : February 26, 2025

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

Duration : 90 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

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

Project Management for CSV in FDA-Regulated Environments (CSA, GAMP®5 2nd Ed.) — with a Brief AI/ChatGPT Overview for PM Support

Project Management for CSV in FDA-Regulated Environments (CSA, GAMP®5 2nd Ed.) — with a Brief AI/ChatGPT Overview for PM Support

Overview: Computer System Validation (CSV) has underpinned FDA compliance in regulated industr..

Date : 30th October 2025

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

Duration : 90 Mins

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