Our training modules are developed by industry experts with over 20+ years of experience in automation, instrumentation, validation, and regulatory compliance.
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On-Site Training
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Empowering Professionals Through CSV and Compliance Expertise
Our Training and Development Program is designed to equip professionals in the pharmaceutical, healthcare, and life sciences industries with the technical knowledge and regulatory understanding required to excel in Computerized System Validation (CSV) and GxP Compliance.
We focus on practical, hands-on learning that helps engineers, quality professionals, and IT teams understand how to implement and maintain validated systems as per 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 guidelines.
Training Modules Offered
1. Basic Introduction to Computer System Validation (CSV)
- What is Validation and CSV?
- Importance of documentation and lifecycle management
- Regulatory expectations: FDA, MHRA, WHO, TGA
- System life cycle (URS, IQ, OQ, PQ, etc.)
2. GAMP 5 Life Cycle Approach
- Understanding GAMP 5 model and key principles
- Software categorization
- Risk assessment and mitigation
- Validation planning and execution
3. 21 CFR Part 11 & EU GMP Annex 11 Compliance
- Data integrity and audit trails
- Electronic records and electronic signatures
- System security, access control, and change management
- Compliance assessment and deviation handling
4. IT Infrastructure & Application Validation
- Validation of servers, networks, and databases
- ERP, SAP, LIMS, and Document Management Systems
- Clinical research and laboratory software validation
- BMS, SCADA, PLC, EMS, and Pharma Cloud system validation
5. CAPA, Change Control, and Periodic Review
- Root cause analysis and corrective actions
- Managing change in validated systems
- Periodic review templates and best practices
6. Vendor Audit & Regulatory Readiness
- Vendor qualification and documentation review
- Compliance auditing process
- Inspection and audit preparation (USFDA, MHRA, WHO GMP)
Practical Tools & Hands-On Sessions
Validation templates and SOPs
Risk-based validation documentation
Real-time data integrity case studies
System qualification checklists
Audit readiness assessments
Who Can Join
Our programs are suitable for:
- Validation & Quality Engineers
- IT Professionals & System Administrators
- Regulatory Affairs Teams
- Pharma Project Managers & Auditors
- Fresh Graduates aspiring to enter CSV & Compliance
Key Benefits of GSS Training
- Industry-recognized certification from Green Software Solution
- Practical exposure to live validation scenarios
- Trained by experts with 20+ years of field experience
- Job-oriented skills for Pharma, Healthcare & IT sectors
- Boosts readiness for regulatory audits & client projects
Why Choose GSS for CSV Training
- Backed by a team of 18–20 trained validation engineers
- Expertise in global regulatory requirements (USFDA, MHRA, EU GMP)
- Real-world experience in Pharma Automation, SAP, ERP, and Lab Systems
- Focus on practical learning, not just theory