Boot Camp Agenda
Computer System Validation (CSV) Boot Camp
Day 1: CSV Foundations, Software Models & Requirements
Build the foundation for validating GxP systems using CSV, CSA, GAMP 5, SDLC models, risk-based thinking, and requirements development.
Module 1: CSV Methods and Models
- GxP Systems
- Computer System Validation (CSV)
- Common SDLC Methodologies
- GAMP®5 “V” Model
- 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 2: Validation Testing, Reports & System Maintenance
Learn how to plan, execute, document, release, and maintain validated systems throughout their operational lifecycle.
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: Regulated Data, Vendor Audits, FDA Trends & CSV Exercises
Connect CSV requirements to regulated data, vendor oversight, FDA inspection readiness, and practical hands-on exercises.
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
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
A 3-Day Complete Immersion in the Validation Process
Participants will receive a Professional Certificate with 15 hours of Continuing Education aligned with CSV Course
What You Will Gain from This Training
✔ Comprehensive Checklist of Validation Documents
Step-by-step guidance on required documentation and how to create each effectively.
✔ 15 Hours of Continuing Education Certficate
Structured learning aligned with industry expectations and regulatory requirements.
✔ Detailed Course Materials
Practical, ready-to-use resources to support your validation activities.
✔ Hands-On Exercises
Apply concepts through real-world scenarios and practical assignments.
✔ Final Examination & Evaluation
Assess your understanding and reinforce key learning outcomes.
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.
Who Should Attend
This training is designed for professionals involved in Computer System Validation (CSV), Computer Software Assurance (CSA), and GxP compliance, including:
- CSV & CSA Professionals
- IT, Software & Automation Professionals
- Quality Assurance (QA) & Quality Control (QC) Professionals
- Validation Engineers & System Owners
- Regulatory Affairs & Compliance Professionals
- Manufacturing, Laboratory & Engineering Personnel
- Project Managers, Business Analysts & Subject Matter Experts (SMEs)
- Software Vendors, Consultants & Life Sciences Professionals
Know Your Faculty
Course Speaker
Faculty
Carolyn Troiano
Carolyn Troiano is an award-winning FDA compliance speaker specializing in validation, 21 CFR Part 11 electronic records/signatures, and data integrity.
Her experience includes 34+ years in IT, business, marketing, and compliance leadership and management roles at a variety of Fortune 100 companies across multiple industries.
Her 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. She has weathered numerous layoffs, mergers, and acquisitions, and has demonstrated strong leadership skills in helping staff navigate difficult times.
