Program Overview
This one-day intensive program provides corporate professionals with a deep-dive into Computerized System Validation (CSV) aligned with GAMP 5 and international regulatory expectations (FDA, EMA, WHO). Led by a seasoned industry expert with 25+ years of experience, the course blends foundational understanding with practical applications, using real-life FDA case studies, system lifecycle documentation, and validation simulations. Participants will learn how to apply risk-based approaches, conduct data integrity assessments using ALCOA+ principles, and create essential validation artifacts such as URS and test protocols. Designed to add actionable value, this course enables teams to enhance compliance, reduce risk, and improve validation efficiency.
Features
- Understand the lifecycle, documents, and regulatory framework of CSV
- Apply GAMP 5 principles using the V-model and system categorization
- Execute risk-based validation and data integrity audits (FMEA, ALCOA+)
- Draft and critique validation deliverables such as URS and test protocols
Target audiences
- Quality Assurance
- Regulatory Affairs Team
- IT Compliance Team
- Operations Team
Curriculum
- 5 Sections
- 22 Lessons
- 1 Day
- Conceptual Foundations of CSV & GAMP 56
- 1.1Definitions: CSV, Validation vs Verification
- 1.2Regulatory Drivers: 21 CFR Part 11, Annex 11, GxP
- 1.3GAMP 5 V-Model and System Lifecycle (Planning to Retirement)
- 1.4Software Categories (Cat 1 to Cat 4) with Examples
- 1.5Deliverables: URS, FS, DS, VMP, IQ/OQ/PQ, VSR
- 1.6Key Terms: URS, DS, FS, IQ/OQ/PQ, V-model, GxP, SDLC, CFR 21 Part 11
- Risk-Based Validation & Regulatory Alignment6
- 2.1Risk Management (FMEA, Risk Priority Numbers)
- 2.2Supplier Assessment Strategy
- 2.3Applying ALCOA+ Principles for Data Integrity
- 2.4Examples: Audit Trails, ER/ES compliance, deviations
- 2.5Case Study 1: Warning Letter: MES System Audit Trail not enabled
- 2.6Case Study 2: Failed PQ due to incomplete URS traceability
- Real-World Case Studies & Common Failures4
- 3.1Case 1: LIMS validation failure and CAPA drafting
- 3.2Case 2: APR spreadsheet security flaw – FDA 483 response
- 3.3Case 3: Excel-based batch release sheet not validated
- 3.4Discussion Points: Root cause analysis; Impact mapping (compliance, quality, product release); What should have been done differently?
- Simulation Activity 12
- Creating & Reviewing CSV Artifacts4
Instructor
