CSV (computerized systems validation) – intensive training - 3 modules

Join Us for an Exclusive Online Training: CSV (Computerized Systems Validation). 

Are you a professional in the Pharmaceutical, Biotech, or MedTech industries aiming to elevate your expertise in Quality Management, GxP compliance, and Computerized Systems Validation (CSV)?

This training provides a comprehensive overview of CSV processes, applicable to GMP (Good Manufacturing Practices), EN ISO 13485, and GAMP5® standards, essential for the manufacturing of medicinal products and medical devices.

Led by Flávio Pinto, an experienced Quality Manager with over 10 years of international expertise, this session is meticulously designed to guide you through the CSV journey. You’ll explore its’ integration with the company’s QMS and gain practical insights to excel in this critical area of expertise.

This training is an essential opportunity for professionals aiming to excel in quality management, compliance, and CSV implementation. 

What You’ll Learn: 

• Foundations of CSV: Understand CSV principles, regulatory expectations, and the CSV Validation V-Model. 
• GAMP® 5 Guidelines: Explore categories, risks, requirements and applications for compliance. 
• Validation Process: Learn types of validation and create effective Validation Plans, URS, and GxP Risk Assessments. 
• Testing Protocols: Master IQ, OQ, PQ protocols, data migration, and traceability matrices. 
• System Deployment: Gain insights into validation reports, SOPs, change control, and system releases. 
• Operation & Maintenance: Ensure performance monitoring, manage upgrades, and implement robust business continuity plans. 
• Retirement and Archiving: Manage the system retirement phases effectively and record retention periods. 

Why Attend? Gain insider knowledge from an expert who has: 

• Master CSV Processes: Gain a complete understanding of Computerized Systems Validation (CSV), from principles and guidelines to deployment and maintenance. 
• Regulatory Compliance: Learn how to meet GMP, EN ISO 13485, and GAMP® 5 standards for medicinal products and medical devices. 
• Boost Professional Skills: Develop expertise in validation plans, testing protocols (IQ, OQ, PQ), data migration, and system deployment. 
• Ensure Operational Excellence: Learn best practices for performance monitoring, business continuity, and system archiving to enhance your organization’s efficiency.

Who Should Attend: 

Quality Assurance Professionals, CSV Specialists, Regulatory Affairs Professionals, and anyone seeking to enhance their skills in compliance and operational excellence. 

Training program (3 x 60 min.) 

Module 1 – CSV principles and guidelines:  

• CSV Introduction 
• CSV regulatory expectations 
• Types of validation 
• GAMP® 5 categories and requirements 
• CSV Validation process 
• CSV V-Model 
• CSV Concept Phase 
• Compliance Determination (GxP/not GxP) 
• Supplier Selection 

Module 2 – Project Phase – Functional Sub-Phase:  

• Project Phase – Functional Sub-Phase 
  • Compliance Package Contents 
  • Validation Plan, URS, GxP Risk Assessment 
  • Supplier Assessment  
• Project Phase – Functional Sub-Phase: Validation Protocol 
  • IQ, OQ, PQ test scripts 
  • Data conversion and data migration 
• Project Phase – Verify & deploy Sub-Phase: 
  • PQ 
  • Traceability Matrix 
  • Validation Report 
  • SOPs and T&Q 
  • Non-Conformances & Change control  
  • System Release 
• Discussion of practical cases and professional experience 

Module 3 – Additional concepts in CSV 

• Operation & Maintenance Phase: 
  • Performance Monitoring & Plan 
  • Preventive maintenance 
  • Upgrade, bug fixes and patches 
  • Audit trails 
  • Business continuity plan for computerized systems 
  • Archiving & Back ups 
  • Periodic Review 
• Retirement Phase 
• Batch release 
• Retention Period for digital records 
• Discussion of practical cases and professional experience 

Don’t miss this opportunity to learn from one of the industry’s best. Reserve your spot now and take your expertise to the next level! 

Duration: approx. 90 minutes per modul

Language: English | Handout: English

Speaker: Flavio Pinto

For whole teams we offer attractive special prices with special advantages or develop your own in-house training for you - please contact us.

Note on contingent call-off: When booking this webinar described here, two units will be deducted per participant.