Computer System Validation (CSV)

5/5
114
csv

Duration :

2

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

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.

Description:

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.

Curriculum:

 

Introduction

 

Lesson 1: Introduction to GAMP 5 Guidelines for CSV

  • Roles and Responsibilities

 

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

Author:

ciaran
Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience in Medical Device Development, Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager.

Reviews:

5/5
114
USD: United States (US) dollar ($) ^

$60

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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$60.00 / year

$60.00 / year

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