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Computer System Validation (CSV) and GAMP 5

Rated 5 out of 5
127
csv

Duration :

2

2 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:

In regulated pharmaceutical environments, an unvalidated computerized system is a compliance liability. Computer System Validation (CSV) is the structured process that demonstrates systems perform reliably, protect data integrity, and satisfy regulations including FDA 21 CFR Part 11 1 and EU Annex 11. This course introduces the CSV lifecycle and the GAMP 5 risk-based approach to system classification and validation planning.

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

 

Who should enroll?

  • Quality assurance and validation professionals
  • IT and systems specialists in pharmaceutical and biotech companies
  • Regulatory affairs personnel overseeing computerized systems
  • Project managers involved in system implementation and validation

 

What you’ll learn?

  • Importance and role of CSV in regulated industries
  • Key phases of the CSV lifecycle: concept, project, operation, retirement
  • Best practices for validation planning, documentation, and quality assurance
  • Classification of software and hardware components per GAMP®5 guidelines
  • Development and use of essential validation documents such as CDS and validation plans

 

Curriculum:

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

Author:

Ciaran McEnister
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:

Rated 5 out of 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.
Rafaela SantosCompliance Officer

$95

Buy now

  Large group ? Request a quote !

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.
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$95.00 / year

$95.00 / year

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