Computer System Validation Boot Camp®

3-Day Virtual Seminar

MP3 Download / On Demand

This session will be held via Video Conference over three successive days both Live and On Demand
12 hrs Plus Training Online Live and On Demand Both Options


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Join The Best Online Computer System Validation Training Courses And programs

This current Computerised System Validation Training course is specially designed to have a complete understanding of principles, methodologies, and top and tested practices of computer systems and their validation. As a trainee, you should learn the rules and regulations that always impact your computer system and help you to gain hands-on experience in writing validation documents. This training can help you to emerge as experts in inspection–ready validation projects.

Boot camp is hard and stimulating. It is a three-day process that you can use to complete involvement in the authentication procedure, including industry-best performance and recent advances in skill. As a participant, you will be able to complete hands-on validation events via valid instructions, exercises, and case studies.

Registration Cost Includes:

▪         Specification of credentials and the way how to create

▪         Sequence folder

▪         Many exercises on Authentication Plan, the Necessities Traceability Matrix, and the Authentication Summary Report.

▪         Training Documentation

 

•        We suggest every participating trainee bring a laptop to boot camp. Here, you need strong internet access, spreadsheet, and word processing applications, and a PDF reader.

AGENDA - Day 1

Module 1: Computer System Validation (CSV) Regulations 12:30 PM EDT

▪         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 1:30 PM EDT

▪         Validation, verification, and qualification

▪         Common SDLCs

▪         GAMP 5 “V” Model

▪         COTS, Cloud, SaaS, PaaS, IaaS

▪         Spreadsheet Validation

 

Break 02:45 PM EDT 15 mins

 

Module 3: 21 CFR Part 11 - 03:00 PM EDT

▪         21 CFR Part 11 Guidance

▪         Electronic records/signatures requirements

▪         Exercise: FDA Guidance for ER/ES

 

Data Integrity and Governance - 04:00 PM EDT

 

Session End Time: 05:00 PM EDT

AGENDA – Day 2

Module 4: Validation Planning - 12:30 PM EDT

▪         Proof Strategy Components

▪         Authentication Strategy Document

▪         GAMP 5 System Categorization

▪         Foundation for Validation Testing

 

Module 5: Risk-Based Validation - 02:15 PM EDT

▪         Risk mitigation

▪         Risk assessment

▪         Exercise: Validation Plan writing

 

Break - 03:00 PM EDT

 

Module 6: Requirements - 03:15 PM EDT

▪         User Requirements Specification (URS)

▪         Functional Requirements Specification (FRS)

▪         Requirements development

▪         Exercise: Requirements Interviews and URS/FRS writing

Module 7: System Design and Development - 03:40 PM EDT

▪         System Design Outline (SDS)

▪         Configuration Management Requirement (CMS)

 

Module 8: IQ, OQ, PQ Protocols and Execution - 04:00 PM EDT

▪         Authentication testing procedure

▪         IQ purpose and contents

▪         OQ determination and contents

▪         PQ purpose and contents

 

Module 9: Validation Testing Plan

▪         Values of authentication testing

▪         Testing methods

▪         Testing Plan drive and guts

▪         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: 05:00 PM EDT

AGENDA – Day 3

Module 12: Requirements Traceability Matrix (RTM) 12:30 PM EDT

▪         Trace Matrix drive and contents

▪         Exercise: Trace Matrix writing

 

Module 13: Test and Validation Reports - 12:45 PM EDT

▪         Test Summary purpose and contents

▪         Authentication Report drive and contents

▪         Exercise: Validation Summary Report writing

 

Module 14: Change Management 01:00 PM EDT

▪         Periodic System Review

▪         Upholding authentication rank

▪         Incidence Reporting

▪         Alteration control processes

▪         Audit Trail Review

▪         Security and Access

 

Module 15: System Retirement 02:00 PM EDT

▪         Record retention

▪         Retirement challenges

Break at 02:30 PM EDT 15 mins

Break at 02:30 PM EDT 15 mins

 

Module 16: FDA Warnings Letters 02:45 PM EDT

▪         Present Tendencies in Obedience and Execution

▪         Case Study: FDA implementation

▪         Exercise: Be the Advisor

 

Module 17: Q/A Session & CSV Exam 04:00 PM EDT

▪         Action: Exam Training

▪         Final Exam

▪         Q/A Session with the Course Instructor

 

Session End Time: 05:00 PM EDT

Objectives of Learning:

▪         Empathetic of how to obey important FDA and global CSV rules and directions, such as 21 CFR Part 11 and Annex 11

▪         The resolution of each authentication deliverable and hands-on repetition of creating each deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Trace Matrix, Test Summary, and Validation Report

▪         Understanding of risk-based authentication methods and how to leverage these techniques to create efficient yet compliant validation approaches

▪         Suitable endorsement strategies for numerous applications, including spreadsheets, COTS, Cloud/SaaS, and custom-developed systems

▪         Consciousness of best practices and examiner prospects for computer system authentication and software excellence assurance (SQA) programs

Possible Beneficiaries of Computerized System Validation Training

Personnel in the following roles will benefit:

▪         Vendors responsible for software development, testing, and maintenance

▪         Supply Chain Specialists and Managers

▪         Information Technology Analysts

▪         Clinical Data Analysts

▪         Computer System Validation Specialists

▪         Laboratory Managers

▪         QC/QA Managers and Analysts

▪         Business Stakeholders/Subject Matter Experts

▪         Analytical Chemists

▪         Business System/Application Testers

▪         Regulatory Submissions Specialists

▪         Compliance and Audit Managers

▪         Manufacturing Specialists and Managers

▪         Clinical Data Managers

▪         Regulatory Affairs Specialists

▪         Information Technology Developers and Testers

▪         Automation Analysts

▪         Risk Management Professionals

▪         Software Quality Assurance Professionals

▪         Clinical Trial Sponsors

▪         GMP Training Specialists

▪         Professionals 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

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Faculty Carolyn Troiano

Faculty Carolyn Troiano

Award winning FDA Compliance Expert 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.