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Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA

Business Process Mapping – How to Prepare a Detailed System & Data Roadmap for a Clinical Trial Regulated by FDA

Overview: Conducting human clinical trials requires strict adherence to government regulatory ..

Date : 30th October, 2024

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

Duration : 90 Mins

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

10 Minutes excerpt from the recorded event for your review:Read the LinkedIn Article: LinkedIn ..

Date : 30th May 2024

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

Duration : 90 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 : 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

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

Water Systems in Pharmaceutical Manufacturing Industry

Water Systems in Pharmaceutical Manufacturing Industry

Overview: This seminar will provide an overview of water systems used for pharmaceutical manu..

Date : 22nd September 2022

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

Duration : 60 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

21 CFR Part 820 - Quality System - Principles of Lean Documents and Lean Configuration

21 CFR Part 820 - Quality System - Principles of Lean Documents and Lean Configuration

Overview: All life science businesses are required to maintain their Quality Management Syste..

Date : 21st September 2021

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

Duration : 1 Hour 30 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

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

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