CSV & GAMP Training

Overview

Mediature GxP Solutions Pvt. Ltd. (MGS) provides CSV & GAMP Training for pharmaceutical, biopharmaceutical, API, medical-device, laboratory, CRO, and other regulated organizations.

Our training focuses on risk-based validation, intended use, critical functions, system lifecycle controls, documentation, testing, and maintenance of the validated state.

Key Training Areas

• Computer System Validation (CSV)
• GAMP 5 Principles
• Computer Software Assurance (CSA)
• GxP Impact Assessment
• User Requirement Specification (URS)
• Risk Assessment
• Validation Planning
• IQ / OQ / PQ Concepts
• Risk-Based Testing
• Traceability
• 21 CFR Part 11
• EU Annex 11
• Audit Trails
• User Access Controls
• Data Migration
• Cloud Systems
• Change Control
• Periodic Review

Training Formats

• On-site training
• Virtual training
• CSV workshops
• GAMP-focused sessions
• System-specific training
• Validation-documentation workshops
• Case studies
• Knowledge assessments

Why Choose MGS

• Practical CSV perspective
• Risk-based learning
• Regulatory and technical integration
• Role-specific training
• Documentation-focused approach

Who We Support

• Pharmaceutical manufacturers
• API manufacturers
• Biopharmaceutical organizations
• Medical-device companies
• Laboratories and CROs
• QA, validation, IT, system owners, and business users