Computer System Validation Professional Certification Program 3 Days

CSV Course Description

This computer system validation course is designed to completely immerse you in the principles, methods, and best practices of Computer System Validation (CSV). You will learn about the regulations that impact your systems and gain hands-on practice writing validation documents. You will leave ready to lead efficient, effective, inspection–ready validation projects, whether you choose to follow a traditional waterfall or agile methodology.

Boot camp is tough and challenging. It is a three-day complete immersion in the validation process, including industry best practices and more recent advances in technology. Participants will complete hands-on validation activities through instruction, exercises, and case scenarios.

Registration Cost Includes:

• Checklist of documents and the direction for how to create
• Course binder
• Many exercises on Validation Plan, the Requirements Traceability Matrix, and the Validation Summary Report.
• Training Certification

Please bring a laptop to boot camp. You will need internet access, spreadsheet and word processing applications and a PDF reader.

AGENDA - Day 1

Module 1: Regulation for CSV 12:00 PM

• FDA Regulations and Guidance
• Other Regulations and Guidance (EMA, ICH, EU, MHRA, PIC/S)
• Exercise: Exploring the Regulations using the fda.gov website

Module 2: Validation Method and Models 01:00 PM

• Validation, verification, and qualification
• Common SDLCs
• GAMP 5 “V” Model
• COTS, Cloud, SaaS, PaaS, IaaS
• Spreadsheet Validation

Break 02:15 PM EDT

Module 3: 21 CFR Part 11 - 02:30 PM EDT

• 21 CFR Part 11 Guidance
• Electronic records/signatures requirements
• Exercise: FDA Guidance for ER/ES

Data Integrity and Governance - 03:30 PM EDT

Session End Time : 04:30 PM EDT

AGENDA – Day 2

Module 4: Validation Planning -12:00 PM

• Validation Strategy Document
• Validation Strategy Components
• Rationale for Validation Testing
• GAMP 5 System Categorization

Module 5: Risk-Based Validation - 01:45 PM

• Risk assessment
• Risk mitigation
• Exercise: Validation Plan writing

Break 02:30 PM

Module 6: Requirements 02:45 PM

• Requirements development
• User Requirements Specification (URS)
• Functional Requirements Specification (FRS)
• Exercise: Requirements Interviews and URS/FRS writing

Module 7: System Design and Development 03:10 PM

• System Design Configuration (SDS)
• Configuration Management Specification (CMS)

Module 8: IQ, OQ, PQ Overview 03:30 PM

• Validation testing process
• IQ purpose and contents
• OQ purpose and contents
• PQ purpose and contents

Module 9: Validation Testing Plan

• Principles of validation testing
• Testing techniques
• Testing Plan purpose and contents
• Exercise: Testing Plan writing

Module 10: IQ, OQ, PQ Protocols

• Protocol structure and contents
• Objective evidence
• Test writing best practices
• Test structure best practices
• Exercise: IQ/OQ/PQ writing

Module 11: Test Execution

• Test execution best practices
• Validation failure documentation
• Exercise: Validation test execution

Session End Time : 04:30 PM

AGENDA – Day 3

Module 12: Trace Matrices 12:00 PM

• Trace Matrix purpose and contents
• Exercise: Trace Matrix writing

Module 13: Test and Validation Reports 12:15 PM

• Test Summary purpose and contents
• Validation Report purpose and contents
• Exercise: Validation Summary Report writing

Module 14: Change Management 12:30 PM

• Maintaining validation status
• Change control processes
• Security and Access
• Audit Trail Review
• Incidence Reporting
• Periodic System Review

Module 15: System Retirement 01:30 PM

• Record retention
• Retirement challenges

Module 16: FDA Warnings Letters 02:15 PM

• Current Trends in Compliance and Enforcement
• Case Study: FDA enforcement
• Exercise: Be the Consultant

Module 17: CSV Exam 03:30 PM

• Activity: Exam Preparation
• Final Exam

Session End time 04:30 PM

Learning Objectives

• Understanding of how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
• The purpose of each validation deliverable and hands-on practice creating each deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Trace Matrix, Test Summary, and Validation Report
• Comprehension of risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches
• Appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom developed systems
• Awareness of best-practices and inspector expectations for computer system validation and software quality assurance (SQA) programs

Who Should Attend CSV Course

Personnel in the following roles will benefit:

• Information Technology Analysts
• Information Technology Developers and Testers
• Software Quality Assurance Professionals
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Vendors responsible for software development, testing and maintenance
• Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Participant Testimonials

The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterwards about it. Thank you WCS for bringing on board such wonderful experts.

Robert Friedland , IT Manager NUTEK BRAVO, LLC.

For me the training was useful in order to clarify requirements from the FDA in regards to the expectation for the Computerised System Validation process. I will definitely recommend this course to others.

Yorlehin Robiou , Quality Systems and Compliance Manager, Jabil Healthcare

Attendee Question from our last CSV Training

What should be done if there is no audit trial capability for a system?

Faculty Answer If there is no audit trial capability for a system then that does not get you off the hook with FDA.You have to produce some evidence that you know what changes you can make where you show objectively the entire history of the record.