Computer System Validation Training Boot Camp®

Get ready to master the ins and outs of computer system validation with this hands-on boot camp designed for pros and newbies alike.

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RAPS: This course has been pre-approved by RAPS as eligible for up to 15.0 credits towards a participant's RAC recertification upon full completion.

Registration Includes:

• Checklist of documents and the direction for how to create
• Course Material
• Exercises to get a grasp on practical approaches.
• Final Examination and Evaluation
• Training Certification
• Hands-On Training
• 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.

Please bring a laptop to boot camp. You will need internet access, spreadsheet and word processing applications and a PDF reader.

EXERCISES: Independent Study

• The following exercises will be included in the course content and can be completed at each attendee’s discretion. If completed before the end of the Boot Camp, the attendee may ask questions during any Q&A session. If completed after the Boot Camp, the attendee may ask questions via Compliance Trainings and a response will be sent as quickly as possible. Note that both questions and answers are provided for each exercise.
  Exercise 1: Exploring the Regulations using the fda.gov website
• Exercise 2: FDA Guidance for ER/ES
• Exercise 3: Validation Master Plan (VMP) Writing
• Exercise 4: Interviews and URS/FRS Writing
• Exercise 5: IQ, OQ, PQ Test Protocol Writing
• Exercise 6: RTM Writing
• Exercise 7: VSR Writing
• Exercise 8: Be the Consultant - Example of a Data Integrity Audit by FDA at a pharmaceutical manufacturer

CSV Final Exam:

Completed at the discretion of the attendee. Note that both questions and answers are provided for each exercise. (100 Questions/Answers)

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This seminar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.

We’ll also cover COTS, SaaS, IaaS, PaaS, and cloud services, indicating the benefits and risks of each model. In discussing these hardware and software options, we’ll include the best practices for meeting FDA’s requirements for validation, 21 CFR Part 11, as applicable, and data integrity. Part of the session will identify the FDA’s current concerns and how to ensure your systems will meet their expectations.

Day 1

Module 1: CSV Methods and Models

• GxP Systems
• Computer System Validation (CSV)
• Common SDLC Methodologies
• GAMP®5 “V” Model
• Computer System Validation (CSV) vs. Computer Software Assurance (CSA)
• Critical Thinking
• Waterfall vs. Agile Methodology

Module 2: Software and Services

• Computer Off-the-Shelf (COTS) Software
• Cloud Systems
• Software as a Service (SaaS)
• Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)
• Single Sign On (SSO)
• Medical Devices using Software.
• Software-as-a-Medical Device (SaaMD)
• Mobile Devices
• Spreadsheet Validation

Module 3: CSV Planning

• Validation Plan
• Rationale for Validation Testing
• GAMP®5 System Categorization
• Risk Assessment and Mitigation

Module 4: System Requirements and Design

• · Requirements Development
• · User Requirements Specification (URS)
• · Functional Requirements Specification (FRS)
• · System Design/Configuration Management Specification (SDS/CMS)

Day 1 Q&A Session

Day 2

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

• Validation Protocols - IQ, OQ, PQ
• Validation Test Execution
• Validation Test Summary Report

Module 6: Test and Validation Reports

• · Requirements Traceability Matrix (RTM)
• · Validation Summary Report
• System Acceptance and Release Notification

Module 7: CSV Operations and Maintenance

• · Maintaining a System in a Validated State
• · Disaster Recovery Planning
• · Business Continuity Planning
• · Incident Reporting, Investigation, and Remediation
• · Record Retention
• · System Retirement Challenges
• · Legacy Systems and Integration
• · Spreadsheet Validation

Module 8: CSV Supporting Components

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

Day 3

Module 9: Managing FDA-Regulated Data

• · 21 CFR Part 11 Guidance
• · Electronic Records/Signatures (ER/ES) Requirements
• · Data Integrity: ALCOA+ Principles
• · Data Life Cycle Approach
• · Data Governance
• · Data Privacy: HIPAA, GDPRs, et al

Module 10: Vendor Audit

• · Audit Preparation
• · Audit Execution
• · Post-Audit
• · Vendor Contracts and Service Level Agreements (SLAs)

Module 11: FDA Trends

• · Regulatory Influences
• · Regulatory Trends
• · Current Compliance and Enforcement Trends

Module 12: Inspection Preparation

· FDA Inspection Readiness

Industry Best Practices

Day 3 Q&A Session

Module 13: CSV Exercises

• Exercise 1: CSV
• Exercise 2: Validation Plan (VMP) Writing
• Exercise 3: Risk Assessment
• Exercise 4: FDA Requirements for ER/ES
• Exercise 5: Interviews and URS/FRS Writing
• Exercise 6: IQ, OQ, PQ Test Protocol Writing
• Exercise 7: RTM Writing
• Exercise 8: Be the Consultant

Who will benefit?

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.

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.