10:00 AM - 03:00 PM
Day 1

Module 1: Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
– FDA Compliance and Guidance
– Other Regulations and Guidance (EMA, EU, MHRA)
– Exercise: Exploring the Regulations using the fda.gov website

Module 2: CSV Methods and Models
– GxP Systems
– Computer System Validation (CSV)
– Validation, Verification, and Qualification
– Common SDLC Methodologies
– GAMP 5 “V” Model

Module 3: Software and Services
– Computer Off-the-Shelf (COTS) Software
– Cloud Systems
– FDA’s “Case for Quality”
– Software as a Service (SaaS)
– Case Study: Cloud SaaS
– Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
– Single Sign On (SSO)
– Medical Devices and Software as a Medical Device (SaaMD)
– Software Quality Assurance (SQA) Plan
– Mobile Devices and Medical Application
– Spreadsheet Validation

Module 4: 21 CFR Part 11, FDA’s Guidance for ER/ES
– 21 CFR Part 11 Guidance
– Electronic Records/Signatures (ER/ES) Requirements
– Exercise: FDA Guidance for ER/ES
– Vendor Audit

Module 5: Data Integrity and Governance
– Data Life Cycle Approach
– Data Integrity
– Data Governance

10:00 AM - 03:00 PM
Day 2

Module 6: CSV Planning
– Validation Strategy Document (VSD)
– Validation Strategy Components
– Rationale for Validation Testing
– GAMP 5 System Categorization

Module 7: CSV Supporting Components
– Good Documentation Practices (GDPs)
– Training
– Organizational Change Management (OCM)
– CSV Policies and Procedures

Module 8: Risk-Based CSV
– Risk Assessment
– Risk Mitigation
– Exercise: Validation Master Plan (VMP) Writing

Module 9: System Requirements and Design
– Requirements Development
– User Requirements Specification (URS)
– Functional Requirements Specification (FRS)
– Exercise: Interviews and URS/FRS Writing
– System Design/Configuration Management Specification
(SDS/CMS)

Module 10: IQ, OQ, PQ Test Planning and Execution
– IQ, OQ, PQ Purpose and Contents
– CSV Test Execution
– Exercise: IQ, OQ, PQ Test Protocol Writing
– CSV Test Summary Report

10:00 AM - 03:00 PM
Day 3

Module 11: Requirements Traceability Matrix (RTM)
– RTM Purpose and Contents
– Exercise: RTM Writing

Module 12: Test and Validation Reports
– Validation Summary Report (VSR) Purpose and Contents
– System Acceptance and Release Notification

Module 13: Change Management
– Maintaining Validation Status
– Change Control Process
– Security and Access
– Audit Trail Review
– Incident Reporting
– Periodic System Review
– Disaster Recovery Planning
– Business Continuity Planning

Module 14: System Retirement
– Record Retention
– System Retirement Challenges
– Legacy Systems and Integration
– Data Migration

Module 15: FDA Warning Letters
– Regulatory Influences
– Regulatory Trends
– Critical Thinking
– Current Compliance and Enforcement Trends
– FDA Inspection Readiness
– Exercise: Be the Consultant
– Industry Best Practices