Computerized Software Validation (CSV)

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Date: Feb 8, 2027
By Sara Levy
Registration
Engineering & Validation Computerized System Validation (CSV)
  • Location: Online
  • Duration: 3 Days
  • Starts at: 09:00
  • Language: Hebrew

Computerized Software Validation (CSV) Course

This three-day course provides a comprehensive and structured overview of global regulatory requirements for Computerized Software Validation, including FDA 21 CFR Part 11, EU GMP Annex 11, IEC 62304 and the GAMP 5 framework.

Through practical examples and structured sessions, participants will develop skills in audit trails, risk assessment, software testing and assurance strategies.

The course emphasizes critical thinking and a risk-based validation approach, enabling participants to question assumptions, identify hidden risks and focus validation efforts on threats to data integrity, patient safety and product quality.

 

Course Details

Duration: 3 days | 28 academic hours
Dates: 08.02.2027, 10.02.2027 and 15.02.2027
Hours: 09:00–16:00

 

What You Will Learn

  • Foundational and advanced regulatory requirements relevant to CSV in regulated industries
  • Audit-trail testing, risk-based validation and software requirement structure
  • Critical thinking for distinguishing system risks from product- or process-related risks
  • CSA principles and current regulatory expectations
  • IQ, OQ and PQ protocols
  • Validation of spreadsheets
  • Practical lessons from Warning Letters and audit scenarios
  • Designing lean and focused CSV processes aligned with regulatory priorities

 

Who Should Attend?

  • Quality Assurance and Quality Control professionals in regulated industries
  • Regulatory Affairs, Validation and Compliance specialists
  • System owners and project managers in pharmaceuticals, medical devices and life sciences
  • IT and Software Validation practitioners
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Sara Levy

Sara has a B.Sc. in Industrial and Management Engineering with more than 28 years of experience in the field of Information Systems and Quality Assurance serving a variety of industries including Oil & Gas, Telecommunications, Software Development and in the Pharmaceutical, Biotech and Device manufacturing industries. Highly proficient in Computerized Systems Validation and Data Integrity […]
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