Computer Validation Software

Expert in Life science & IT domain

Participants in Live Interactive sessions

Computer System Validation (CSV) Training

The ”Computer System Validation” course is designed to provide end to end understanding on all CSV deliverable. This course also covers the FDA, ICH, and Eudralex, GAMP 5 expectations for life cycle & risk-based validation approach.

Our trainer’s (expert in Life science & IT domain) will focus to enhance your knowledge and to implement CSV practices in your company.

Trainer will engage all participants in Live Interactive sessions.

Assessment & Certification

Easy Knowledge

Upon completion of each module trainer will assess the learner and provide the feedback to enhance the learner knowledge level.

Completion Certificate

At the end of the course, online exam will be conducted and based on the outcome we will provide the Course completion certificate.

CSV Fundamentals
GAMP 5 Principles
21 CFR part 11 ER & ES Concepts
Change Management
GxP Assessment & GAMP Categorization
Audit Management
Validation Plan & Validation Summary
Quality Risk Management
Requirement Specifications (URS, FS and DS)
Software Development Process (SDLC) basic concepts
Verification (IQ, OQ & PQ)
Defect / Deviation Management & CAPA Management
Periodic Review
System Retirement
Data Migration
Spread Sheet Validation
Regulatory Compliance in Cloud
Business Continuity Management and Disaster Recovery Management
Computer System Assurance (CSA)

For Registration

Please reach out to our career counselor’s (+91 8074626306)




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