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Learn Computer System Validation Professional Certificate Program Online
This computer system validation 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 Certification
Please bring a laptop to boot camp. You will need 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
- Validation Strategy Document
- Validation Strategy Components
- Rationale for Validation Testing
- GAMP 5 System Categorization
Module 5: Risk-Based Validation - 02:15 PM EDT
- Risk assessment
- Risk mitigation
- Exercise: Validation Plan writing
Break - 03:00 PM EDT
Module 6: Requirements - 03:15 PM EDT
- Requirements development
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- Exercise: Requirements Interviews and URS/FRS writing
Module 7: System Design and Development - 03:40 PM EDT
- System Design Configuration (SDS)
- Configuration Management Specification (CMS)
Module 8: IQ, OQ, PQ Protocols and Execution - 04:00 PM EDT
- 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 Time : 05:00 PM EDT
AGENDA – Day 3
Module 12: Requirements Traceability Matrix (RTM) 12:30 PM EDT
- Trace Matrix purpose and contents
- Exercise: Trace Matrix writing
Module 13: Test and Validation Reports - 12:45 PM EDT
- Test Summary purpose and contents
- Validation Report purpose and contents
- Exercise: Validation Summary Report writing
Module 14: Change Management 01:00 PM EDT
- Maintaining validation status
- Change control processes
- Security and Access
- Audit Trail Review
- Incidence Reporting
- Periodic System Review
Module 15: System Retirement 02:00 PM EDT
- Record retention
- Retirement challenges
Break at 02:30 PM EDT 15 mins
Module 16: FDA Warnings Letters 02:45 PM EDT
- Current Trends in Compliance and Enforcement
- Case Study: FDA enforcement
- Exercise: Be the Consultant
Module 17: Q/A Session & CSV Exam 04:00 PM EDT
- Activity: Exam Preparation
- Final Exam
- Q/A Session with the Course Instructor
Session End Time : 05:00 PM EDT
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 CSV Course
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
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
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.
My role has often been that of a liaison between technical and business staff, translating business needs into people, process and technical solutions, and developing ROI and risk models used to support funding.
I completed an MBA degree from Rutgers University with emphasis on Organizational Development and Marketing, and have extensive training and experience in leadership, project management, compliance, marketing, diversity, change management, and mentoring. These skills have enabled me to manage and partner with a broad range of individuals at a variety of levels in a wide range of organizational cultures.
With my creativity, insight and tenacity, along with excellent communication and analytical problem-solving skills, I can help raise your organization to a new level!
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
Tracey Kessler ( Director of R&D) CEL-SCI Corporation
I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals