Dublin, Aug. 17, 2026 (GLOBE NEWSWIRE) -- The "Computer System Validation (CSV) Implementation Boot Camp: Practical Validation of GxP Computerised Systems (Aug 19th - Aug 21st, 2026)" has been added to ResearchAndMarkets.com's offering.
3-Day Computer System Validation Training and FDA Compliance Boot Camp
This intensive three-day Computer System Validation (CSV) Boot Camp provides 15 hours of continuing education focused on validation processes, regulatory compliance and system life cycle management. Participants who complete the program will receive a Professional Certificate and a Continuing Education Certificate aligned with the CSV course.
Designed for professionals working in regulated environments, the training addresses current FDA expectations, validation documentation, 21 CFR Part 11 compliance and data integrity. Participants will examine practical approaches for developing, validating and maintaining computerized systems throughout their operational life cycles.
What Participants Will Gain
Comprehensive Validation Documentation Checklist
Participants will receive step-by-step guidance on the documents required to support an effective computer system validation program. The course explains how to prepare, review and maintain key validation records in accordance with applicable regulatory and industry expectations.
15 Hours of Continuing Education
The structured curriculum provides 15 hours of professional continuing education. Course content is aligned with established CSV practices, FDA requirements and the responsibilities associated with maintaining regulated computerized systems.
Detailed Computer System Validation Course Materials
Attendees will receive practical course materials and ready-to-use resources that can support validation planning, documentation, testing and ongoing compliance activities.
Hands-On CSV Exercises
Real-world scenarios and practical assignments allow participants to apply course concepts to validation challenges commonly encountered in pharmaceutical, biotechnology, medical device and other FDA-regulated organizations.
Final Examination and Evaluation
A 100-question CSV final examination is available for completion at each participant's discretion. Questions and answers are provided to reinforce key learning outcomes and help attendees evaluate their understanding of the course content.
Independent Study Exercises
The following exercises are included with the training and may be completed at the attendee's discretion. Participants who complete exercises before the Boot Camp concludes may raise questions during scheduled question-and-answer sessions. Questions submitted after the program may be directed to Compliance Trainings for a response. Questions and answers are included with each exercise.
- Exercise 1: Exploring regulations through the FDA website
- Exercise 2: FDA guidance for ER/ES
- Exercise 3: VMP writing
- Exercise 4: Interviews and URS/FRS writing
- Exercise 5: IQ, OQ and PQ test protocol writing
- Exercise 6: RTM writing
- Exercise 7: VSR writing
- Exercise 8: Data integrity audit case study involving an FDA inspection of a pharmaceutical manufacturer
Computer System Validation in a Changing Technology Environment
Rapid advances in technology continue to transform business models, operational processes and regulatory responsibilities. Regulated organizations must adapt their work practices and technology controls while meeting the expectations of informed patients, customers, inspectors and other stakeholders.
The course examines how software should be developed, validated and maintained in a validated state throughout the system life cycle. Participants will compare agile and waterfall methodologies, including the advantages, limitations and compliance considerations associated with each approach. The program emphasizes selecting a methodology based on system requirements, risk, intended use and the organization's regulatory obligations.
Cloud Services, Commercial Software and FDA Requirements
The training also addresses COTS, SaaS, IaaS, PaaS and cloud services, with attention to the benefits and risks associated with each technology and service model. Participants will review best practices for validating hardware and software environments while supporting FDA compliance, 21 CFR Part 11 requirements and data integrity controls.
Current FDA concerns are incorporated throughout the program to help attendees identify potential compliance gaps and strengthen their validation practices. The course provides actionable insight into documentation, testing, risk management and system governance, enabling participants to better prepare computerized systems for regulatory review.
Technology Requirements
Participants must bring a laptop to the Boot Camp. Internet access, spreadsheet software, word processing software and a PDF reader will be required to access course materials and complete practical exercises.
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
Speaker
Carolyn Troiano
For more information about this training visit https://www.researchandmarkets.com/r/yioau9
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