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Computer System Validation (CSV)

 5/5

127

Duration :

1

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:

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

127

I highly recommend this course on Computer System Validation (CSV). The curriculum is well-organized and provides a comprehensive overview of the GAMP 5 Guidelines and the validation process in CSV. The four phases of CSV, including concept, project, operation, and retirement, are explained in detail with practical examples. I found the checklist approach and the glossary of terms extremely helpful in ensuring that I understood the concepts thoroughly. The quiz at the end of the course was a great way to test my knowledge and reinforce my learning. Overall, this course is an excellent resource for anyone seeking to gain a better understanding of CSV.

$60

Participant(s):

Buy now

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This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.