3 Day Computer System Validation (CSV) Virtual Seminar: October 31, 2022 - November 2, 2022
Dublin, Oct. 07, 2022 (GLOBE NEWSWIRE) -- The "Computer System Validation ( CSV) 3 Day Virtual Seminar" training has been added to ResearchAndMarkets.com's offering.
This 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 Certificate
Please bring a laptop to boot camp. You will need internet access, spreadsheet and word processing applications and a PDF reader.
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:
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
Key Topics Covered:
AGENDA - Day 1
Module 1: Computer System Validation (CSV) Regulations
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: Computer System Validation Method and Models
Validation, verification, and qualification
Common SDLCs
GAMP 5 "V" Model
COTS, Cloud, SaaS, PaaS, IaaS
Spreadsheet Validation
Break 15 mins
Module 3: 21 CFR Part 11
21 CFR Part 11 Guidance
Electronic records/signatures requirements
Exercise: FDA Guidance for ER/ES
Data Integrity and Governance
Session End Time : 05:00 PM EDT
AGENDA - Day 2
Module 4: Validation Planning
Validation Strategy Document
Validation Strategy Components
Rationale for Validation Testing
GAMP 5 System Categorization
Module 5: Risk-Based Validation
Risk assessment
Risk mitigation
Exercise: Validation Plan writing
Break
Module 6: Requirements
Requirements development
User Requirements Specification (URS)
Functional Requirements Specification (FRS)
Exercise: Requirements Interviews and URS/FRS writing
Module 7: System Design and Development
System Design Configuration (SDS)
Configuration Management Specification (CMS)
Module 8: IQ, OQ, PQ Protocols, and Execution
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
AGENDA - Day 3
Module 12: Requirements Traceability Matrix (RTM)
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
Incidence Reporting
Periodic System Review
Module 15: System Retirement
Record retention
Retirement challenges
Break 15 mins
Module 16: FDA Warnings Letters
Current Trends in Compliance and Enforcement
Case Study: FDA enforcement
Exercise: Be the Consultant
Module 17: Q/A Session & CSV Exam
Activity: Exam Preparation
Final Exam
Q/A Session with the Course Instructor
Session End
For more information about this training visit https://www.researchandmarkets.com/r/igihmb
CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood,Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900