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Computer System Validation Boot Camp (September 6-10, 2021)

  • ID: 5359092
  • Training
  • September 2021
  • Region: Global
  • 5 Days
  • World Compliance Seminar
  • Training Dates: September 6-10, 2021

Computer System Validation Professional Certificate Program

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.

Boot camp is tough and challenging. It is a five-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.

Our Training Approach

We have designed 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.

What You Get

  • Understanding of how the CSV process fits into your Software Life Cycle (SDLC or SALC) and the purpose of each validation deliverable
  • Hands-on practice creating key validation deliverables, including Validation Plans, Requirements Specifications, Test Plans, Validation Tests (IQ, OQ, PQ), Trace Matrices, Test Summaries, and Validation Reports
  • Best practices for validation test execution, documentation, and error handling
  • Comprehension of what software does and does not require validation
  • Methodology and implementation model for a risk-based approach to CSV
  • Details on how to leverage risk-based decision making in your software quality assurance procedures
  • Understanding of the key components and principles of a software quality assurance (SQA) program and auditor expectations
  • Understanding of the key FDA and international regulations and guidance regarding CSV and which apply to your company
  • Current data and 9 years of trends on the most common FDA Warnings regarding software validation and system quality
  • BONUS: Course registration includes 23 hrs Instructor Led Training Online, Course Binder Electronic Copy, CSV Exam & CSV Certification.
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DAY 1

Module 1: FDA Compliance

  • Therac 25 Case Study
  • Lessons for today
  • Impact on CSV regulations
  • FDA Predicate Rules
  • FDA Compliance and Enforcement
  • FDA Inspection
  • FDA Compliance Toolset
  • FDA Form 483
  • FDA Warning Letter
  • FDASIA
  • Eudralex Annex 11, 20, and III
  • ICH Guidelines
  • PIC/S Guides
  • Exercise: Exploring the regulations
  • Exercise: Using FDA.gov
  • Quiz: FDA Guidance

Module 2: CSV Methods and Models

  • GxP Systems
  • Computer System Validation (CSV)
  • Validation, Verification, and Qualification
  • Common SDLC Methodologies
  • GAMP 5 “V” Model
  • Computer System Validation (CSV) vs. Computer Software Assurance (CSA)
  • Waterfall vs. Agile Methodology

DAY 2

Module 3: CSV Planning

  • Validation Strategy Document (VSD)
  • Validation Strategy Components
  • Rationale for Validation Testing
  • GAMP 5 System Categorization
  • Risk Assessment
  • Risk Mitigation
  • Exercise: Risk Assessment

Module 4: System Requirements and Design

  • Requirements Development
  • User Requirements Specification (URS)
  • Functional Requirements Specification (FRS)
  • System Design/Configuration Management Specification (SDS/CMS)
  • Exercise: Application and Design

Module 5: IQ, OQ, PQ Test Planning & Execution

  • IQ, OQ, PQ Purpose and Contents
  • CSV Test Execution
  • CSV Test Summary Report

Module 6: Test and Validation Reports

  • Requirements Traceability Matrix (RTM) Purpose and Contents
  • Validation Summary Report (VSR) Purpose and Contents
  • System Acceptance and Release Notification

DAY 3

Module 7: CSV Operations and Maintenance

  • Maintaining a System in a Validated State
  • Disaster Recovery Planning
  • Business Continuity Planning
  • Record Retention
  • System Retirement Challenges
  • Legacy Systems and Integration
  • Data Migration

Module 8: CSV Supporting Components

  • Good Documentation Practices (GDPs)
  • Training
  • Organizational Change Management (OCM)
  • CSV Policies and Procedures

Module 9: Managing FDA-Regulated Data

  • 21 CFR Part 11 Guidance
  • Electronic Records/Signatures (ER/ES) Requirements
  • Data Life Cycle Approach
  • Data Integrity
  • Data Governance

DAY 4

Module 10: Software and Services

  • Computer Off-the-Shelf (COTS) Software
  • FDA’s “Case for Quality”
  • Cloud Systems
  • Software as a Service (SaaS)
  • Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
  • Single Sign On (SSO)
  • Medical Devices and Software as a Medical Device (SaaMD)
  • Mobile Devices and Medical Application
  • Spreadsheet Validation

Module 11: Vendor Audit

  • Audit Preparation
  • Audit Execution
  • Post-Audit

Module 12: FDA Trends

  • Regulatory Influences
  • Regulatory Trends
  • Critical Thinking 
  • Current Compliance and Enforcement Trends

DAY 5

Module 13: Inspection Preparation

  • FDA Inspection Readiness
  • Industry Best Practices

Module 14: CSV Exercises

  • Exercise 1: CSV
  • Exercise 2: Validation Master Plan (VMP) Writing
  • Exercise 3: FDA Requirements for ER/ES
  • Exercise 4: Interviews and URS/FRS Writing
  • Exercise 5: IQ, OQ, PQ Test Protocol Writing
  • Exercise 6: RTM Writing
  • Exercise 7: Be the Consultant
  • Final Exam Prep
  • Take Home Final Exam
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  • Carolyn Troiano Carolyn Troiano,
    Webinar/Seminar/Workshop Instructor in FDA Compliance Training


    Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs

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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
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