Computer System Validation (CSV) Implementation Boot Camp: Practical Validation of GxP Computerised Systems (ONLINE EVENT: August 19-21, 2026)

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.