We value your privacy
We use cookies to enhance your browsing experience, serve personalized ads or content, and analyze our traffic. By clicking "Accept All", you consent to our use of cookies. Read here our Privacy Policy
We use cookies to help you navigate efficiently and perform certain functions. You will find detailed information about all cookies under each consent category below.
The cookies that are categorized as "Necessary" are stored on your browser as they are essential for enabling the basic functionalities of the site. ...
Necessary cookies are required to enable the basic features of this site, such as providing secure log-in or adjusting your consent preferences. These cookies do not store any personally identifiable data.
Functional cookies help perform certain functionalities like sharing the content of the website on social media platforms, collecting feedback, and other third-party features.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics such as the number of visitors, bounce rate, traffic source, etc.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Advertisement cookies are used to provide visitors with customized advertisements based on the pages you visited previously and to analyze the effectiveness of the ad campaigns.
Home / Online GXP courses / GMP : Good Manufacturing Practices / Computer System Validation (CSV)
Successful completion provides learners with a dated, traceable and downloadable certificate for the course : Computer System Validation (CSV)
Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.
By taking this course, you will gain a comprehensive understanding of Computer System Validation (CSV), its significance in regulated industries, and the associated regulations and standards. The course will equip you with recommendations and best practices for successful CSV implementation, as well as an understanding of the GAMP®5 framework and the essential competencies required for a validation team. At the end of the course, you will have the knowledge and skills necessary to effectively manage electronic data in a regulated environment while ensuring compliance with regulatory guideline such as FDA’s 21 CFR Part 11 and EU Annex 11.
In this course, we provide a synthesis on the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.
Introduction
Lesson 1: Introduction to GAMP 5 Guidelines for CSV
Lesson 2: Validation Process in CSV
Lesson 3: Phase 1 of CSV – Concept Phase
Lesson 4: Phase 2 of CSV – Project Phase
Lesson 5: Phase 3 of CSV – Operation Phase
Lesson 6: Phase 4 of CSV – Retirement Phase
Lesson 7: Multi-Phase and Checklist for CSV
Glossary
Evaluation
$95.00 / year
$95.00 / year
© GxP Training 2021