Computer System Validation (CSV)

About this course

  • Advance Your Career with Our Computer System Validation (CSV) Course for the Pharmaceutical Industry:
  • Ensure Compliance. Safeguard Patient Safety. Drive Operational Excellence!

Are you ready to master Computer System Validation (CSV) and become a vital asset in the pharmaceutical sector?

  • Our comprehensive CSV course is designed to equip you with the knowledge and practical skills needed to validate computerized systems, meet global regulatory requirements, and maintain data integrity throughout the product lifecycle.

Why CSV Training Is Essential?

Regulatory Compliance : Learn how to meet FDA, EMA, and other global regulatory expectations for GxP environments.

Data Integrity : Ensure your systems produce accurate, reliable, and consistent data—crucial for audits and inspections.

Patient Safety : Understand how validated systems protect patient health by preventing critical errors.

Risk Management : Gain tools to identify, assess, and mitigate risks in computerized systems before they impact product quality.

Operational Efficiency : Discover how effective validation minimizes downtime and streamlines production.

Course Highlights

  1. Foundational Principles : Grasp the basics of CSV, including the regulatory landscape, system development life cycle (SDLC), and the V-Model approach.

2. Hands-On Learning : Participate in interactive exercises, real-world case studies, and workshops led by industry veterans.

3. Practical Tools: Develop key validation deliverables—Validation Plans, Requirements Specifications, Test Protocols (IQ, OQ, PQ), Trace Matrices, and Validation Reports.

4. Risk-Based Validation : Learn to apply risk-based methodologies for efficient, inspection-ready validation.

5. 21 CFR Part 11 Compliance : Understand electronic records and signature requirements for pharmaceutical systems.

6. Certificate of Completion : Showcase your expertise with a recognized certificate to boost your career prospects.

Who Should Attend?

Quality Assurance & Quality Control Professionals

Validation Engineers

IT, Pharma Engineering, and Production Professionals Regulatory Affairs & Compliance Officers

Anyone responsible for computerized systems in pharmaceutical, biotech, or medical device sectors.

What You’ll Get?

  • Interactive Live modules and downloadable materials
  • Real-world templates and SOPs for immediate application
  • Access to expert instructors and peer networking
  • Certificate to enhance your resume and demonstrate compliance expertise

Upcoming Sessions

Format

Live Online Classes

Duration

Flexible Options

Locations

Global online access

Enroll Today and Transform Your Compliance Approach!

Don’t miss this opportunity to gain the practical skills and regulatory insight needed to excel in pharmaceutical computer system validation. Secure your spot now and take the next step in your professional journey.

About Course Creator

Mayuri Roy – Director of Sparkling clinitech

  • Experienced Pharmacovigilance Mentor
  • Masters
  • 15 yrs Experience
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