Computerized Software Validation (CSV)

3 Days Training, 09:00-16:00   | 28 academic hours

This three-day Computerized Software Validation (CSV) course delivers a comprehensive and structured exploration of global regulatory requirements—specifically FDA 21 CFR Part 11, EU GMP Annex 11, IEC 62304, and the GAMP 5 framework. Through practical examples and structured sessions, participants will build confidence in audit trails, risk assessment, software testing, and assurance strategies. Additionally, the course emphasizes:

A critical-thinking mindset: empowering participants to go beyond procedural checklists—to thoughtfully question assumptions, anticipate hidden risks, and make judgment-driven validation decisions. Critical thinking helps distinguish system risk contributions from product or process-related risks, a perspective increasingly emphasized in modern CSV/CSA guidance.                                        

A risk-based validation approach: focusing validation efforts on system components that pose the greatest threats to data integrity, patient safety, and product quality. This approach aligns with CSA (Computer Software Assurance) principles and current regulatory expectations to optimize effort and effectiveness.

By the end of the course, participants will be equipped to design CSV processes that are lean, focused, and strategically aligned with regulatory priorities.

Why Attend?

• Learn foundational and advanced regulatory requirements relevant to CSV in regulated industries
• Gain practical insight into audit‑trail testing, risk-based validation, and software requirement structure
• Benefit from real-world examples—such as Warning Letters and audit scenarios—to connect theory with practice
• Enhance your validation toolkit with structured insights into IQ/OQ/PQ protocols, spreadsheets, and more
• Strengthen your compliance posture by aligning your skills with industry standards and expectations

Who Should Attend?

• Quality Assurance (QA) and Quality Control (QC) professionals in regulated industries
• Regulatory Affairs (RA), Validation, and Compliance specialists
• System owners and project managers in regulated sectors such as pharmaceuticals, medical devices, and life sciences
• IT and Software Validation practitioners

When? 2.12.25, 9.12.25, 23.12.25

9:00-16:00   Haifa