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A course designed to completely immerse you in computer system validation. This course delivers comprehension of the regulations impacting your systems and hands-on practice writing validation documents. You will leave ready to lead efficient, effective, inspection-ready validation projects.
Boot camp is tough and challenging. It is a five-day complete immersion in the validation process. Participants will work in focused teams to complete hands-on validation activities through instruction, exercises, and case scenarios. The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles. A balance of instructor lectures, reading materials, exercises and case studies keeps energy levels high and challenges the participants.
Our Training Approach
We have designed a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation but also prepares you to implement these practices in your company. The standard operating procedures and validation templates used in class have already been proven at other companies. We are focused on your comprehension and application of the CSV techniques that will result in efficient, effective, and inspection-ready validation initiatives.
What You Get
Understanding of how the CSV process fits into your Software Life Cycle (SDLC or SALC) and the purpose of each validation deliverable
Hands-on practice creating key validation deliverables, including Validation Plans, Requirements Specifications, Test Plans, Validation Tests (IQ, OQ, PQ), Trace Matrices, Test Summaries, and Validation Reports
Best practices for validation test execution, documentation, and error handling
Comprehension of what software does and does not require validation
Methodology and implementation model for a risk-based approach to CSV
Details on how to leverage risk-based decision making in your software quality assurance procedures
Understanding of the key components and principles of a software quality assurance (SQA) program and auditor expectations
Understanding of the key FDA and international regulations and guidance regarding CSV and which apply to your company
Current data and 9 years of trends on the most common FDA Warnings regarding software validation and system quality
BONUS: Course registration includes 23 hrs Instructor Led Training Online, Course Binder Electronic Copy, CSV Exam & CSV Certification.
Key Topics Covered:
DAY 1
Module 1: FDA Compliance
Therac 25 Case Study
Lessons for today
Impact on CSV regulations
FDA Predicate Rules
FDA Compliance and Enforcement
FDA Inspection
FDA Compliance Toolset
FDA Form 483
FDA Warning Letter
FDASIA
Eudralex Annex 11, 20, and III
ICH Guidelines
PIC/S Guides
Exercise: Exploring the regulations
Exercise: Using FDA.gov
Quiz: FDA Guidance
Module 2: CSV Methods and Models
GxP Systems
Computer System Validation (CSV)
Validation, Verification, and Qualification
Common SDLC Methodologies
GAMP 5 "V" Model
Computer System Validation (CSV) vs. Computer Software Assurance (CSA)
Waterfall vs. Agile Methodology
DAY 2
Module 3: CSV Planning
Validation Strategy Document (VSD)
Validation Strategy Components
Rationale for Validation Testing
GAMP 5 System Categorization
Risk Assessment
Risk Mitigation
Exercise: Risk Assessment
Module 4: System Requirements and Design
Requirements Development
User Requirements Specification (URS)
Functional Requirements Specification (FRS)
System Design/Configuration Management Specification (SDS/CMS)
Exercise: Application and Design
Module 5: IQ, OQ, PQ Test Planning & Execution
IQ, OQ, PQ Purpose and Contents
CSV Test Execution
CSV Test Summary Report
Module 6: Test and Validation Reports
Requirements Traceability Matrix (RTM) Purpose and Contents
Validation Summary Report (VSR) Purpose and Contents
