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CSV Guideline-icoon

2.0 by Innov@tive Appz


Aug 16, 2019

Over CSV Guideline

Basisbegrippen Computersysteemvalidatie

This application will helpful for understanding Basic concepts Computer System Validation in pharmaceutical Industry.

Objectives:

1) You will get familiar with the current regulatory requirements on data integrity and how regulators refine these requirements

2) You will get a deeper understanding what FDA and other global regulatory inspectors expects from pharmaceutical companies in regard to Data Integrity

3) You will learn how to implement the (new) regulatory requirements on Data Integrity into your Pharmaceutical Quality System

4) You will learn how to prepare your company for an successful inspection in regard to Data Integrity

5) You will understand how to establish an effective Data Governance system

6) You will learn how to investigate Data Integrity issues in your company

You Will Learn:

1) Basic & Advance Concepts of Data Integrity

2) Computer System Validation Tips,

3) Mock Inspection Question & Answer

4) Checklist for Inspection

5) Industry Best Practices to Maintain Data Integrity

6) Useful Reference & Resources

7) Current regulatory thinking on Data Integrity

8) And much, much more…

Who Will Benefit:

1) Pharmaceutical/ Medical device / Healthcare/Life science Industry personnel

2) Validation/ IT Service Providers

3) Developers of software for use in Life Sciences industry

4) Regulatory Affairs, Quality Unit

5) Laboratory personnel

6) Clinical Trial Sponsors

Vertaling Laden...

Aanvullende APP -informatie

Laatste Versie

Verzoek update van CSV Guideline 2.0

Android vereist

4.2 and up

Meer Info

Wat is er nieuw in de nieuwste versie 2.0

Last updated on Aug 16, 2019

Minor bug fixes and improvements. Install or update to the newest version to check it out!

Meer Info

CSV Guideline Screenshots

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