Boot camp is tough and challenging. It is a three-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.
Who Should Attend
IT, QA, & Business Managers and Professionals who need to:
Manage or participate on computer system projects requiring validation
Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
Understand the process of computer system validation
Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meeting the latest regulatory expectations
Understand the FDA and international regulatory landscape around CSV.
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.
Registration Cost Includes:
Checklist of documents and the direction for how to create
Many exercises on Validation Plan, the Requirements Traceability Matrix, and the Validation Summary Report.
Please bring a laptop to boot camp. You will need internet access, spreadsheet and word processing applications and a PDF reader.
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.
AGENDA - Day 1
Module 1: Regulation for CSV
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
Validation, verification, and qualification
GAMP 5 “V” Model
COTS, Cloud, SaaS, PaaS, IaaS
Module 3: 21 CFR Part 11
21 CFR Part 11 Guidance
Electronic records/signatures requirements
Exercise: FDA Guidance for ER/ES
Module 4: Validation Planning
Validation Strategy Document
Validation Strategy Components
Rationale for Validation Testing
GAMP 5 System Categorization
Module 5: Risk-Based Validation
Exercise: Validation Plan writing
Module 6: Requirements
User Requirements Specification (URS)
Functional Requirements Specification (FRS)
Exercise: Requirements Interviews and URS/FRS writing
AGENDA – Day 2
Module 7: System Design and Development
System Design Configuration (SDS)
Configuration Management Specification (CMS)
Module 8: IQ, OQ, PQ Overview
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 Plan purpose and contents
Exercise: Testing Plan writing
Module 10: IQ, OQ, PQ Protocols
Protocol structure and contents
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
AGENDA – Day 3
Module 12: Trace Matrices
Trace Matrix purpose and contents
Exercise: Trace Matrix writing
Module 13: Test and Validation Reports
Test Summary purpose and contents
Validation Report purpose and contents
Exercise: Validation Summary Report writing
Module 14: Change Management
Maintaining validation status
Change control processes
Security and Access
Audit Trail Review
Periodic System Review
Module 15: System Retirement
Module 16: FDA Warnings Letters
Current Trends in Compliance and Enforcement
Case Study: FDA enforcement
Exercise: Be the Consultant
Module 17: CSV Exam
Activity: Exam Preparation
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
Why Should You Attend:
We have used our real-world experience to design 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.
Faculty Carolyn Troiano
Midlothian, Virginia, United States
Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.
My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.
My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.