Course Description

Computer System Validation (CSV) is a necessity for Life Science customers. As we all know, validation can expand a project’s scope, increase project costs and put audits at risk if not managed well. Pilgrim’s Validation Boot Camp helps project managers and validation specialists tackle the validation process by looking more closely at a project’s tool and setting audit expectations.
This segment of the Validation immersion training will guide participants through the various paces by expert leadership with daily curricula focused on project planning, IQ, OQ, PQ regulations, Validation Pack training, script execution and customization, and configuration management. 

Learning Outcomes

After completing the Boot Camp, Validation Boot Camp participants will be able to:

• Comprehend overall Validation concepts including 21 CFR Part 11, GAMP4, and Risk Analysis
• Comprehend the Validation Release Note and it’s importance on the change control process for the validation scripts  
• Analyze the documents provided as part of the validation pack and comprehend their importance in the validation project
• Construct a verification plan
• Execute Pilgrim Software’s Validation Pack
   

Course Length

3 days (for Agenda, please contact bootcamp@pilgrimsoftware.com)

Target Audience

IT Project Members, Validation Project Managers, Trainers, Customer/Pilgrim/Pilgrim Partner Implementation Team Members 

Prerequisites

None 

Method of Evaluating Performance

Pilgrim Customers are required to take the evaluation exam to complete the requirements of the Boot Camp. The exam is taken at the conclusion of the Boot Camp.

Multiple Choice Exam
The multiple choice exam (worth 100 points) is used to evaluate validation concepts and focuses on the Pilgrim Software Validation Pack. The exam includes general validation questions, as well as specific questions on Pilgrim Software’s Validation Pack. 

Practical Exam
All participants will perform a hands-on exercise (worth 100 points) based on a Pilgrim Software validation script to ensure that they are ready to begin their validation project. The trainee will need to execute an entire validation script based on the information learned in the Boot Camp.