3 Day Computer System Validation (CSV) Virtual Seminar: October 31, 2022 - November 2, 2022

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Oct 12, 2022, 06:00 ET

DUBLIN, Oct. 12, 2022 /PRNewswire/ -- 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/zf4b5z

Media Contact:
Research and Markets
Laura Wood, Senior Manager
[email protected]

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SOURCE Research and Markets