Computer System Validation Boot Camp®

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A 5-Day Complete Immersion in the Validation Process

Our CSV boot camp is challenging. Participants will work in focused teams to complete hands-on validation activities through instruction, exercises, and case scenarios. The course moves quickly and participants will change gears often to accommodate multiple learning styles. A balance of instructor lectures, reading materials, hands-on activities, and competitions keeps energy levels high and challenges the participants.

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Our Training Approach:

We have designed a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation, but also prepares you to implement these practices in your company. The standard operating procedures and validation templates used in class have already been proven at other companies. We are focused on your comprehension and application of the CSV techniques that will result in efficient, effective, and inspection-ready validation initiatives.

What You Get:

  • Understanding of how the CSV process fits into your Software Life Cycle (SDLC or SALC) and the purpose of each validation deliverable
  • Hands-on practice creating key validation deliverables, including Validation Plans, Requirements Specifications, Test Plans, Validation Tests (IQ, OQ, PQ), Trace Matrices, Test Summaries, and Validation Reports
  • Best practices for validation test execution, documentation, and error handling
  • Comprehension of what software does and does not require validation
  • Methodology and implementation model for a risk-based approach to CSV
  • Details on how to leverage risk-based decision making in your software quality assurance procedures
  • Understanding of the key components and principles of a software quality assurance (SQA) program and auditor expectations
  • Understanding of the key FDA and international regulations and guidance regarding CSV and which apply to your company
  • Current data and 9 years of trends on the most common FDA Warnings regarding software validation and system quality
  • BONUS: Course registration includes a free bundle of our Delivery & SOP Templates (38 documents – a $960 value!)

Who Should Attend Computer System Validation Training?

IT, QA, & Business Managers and Professionals who need to:

  • Manage or participate in computer system projects requiring validation
  • Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), Test Plans, and Test Reports.
  • Understand the process of computer system validation
  • Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meeting the latest regulatory expectations
  • Understand the FDA and international regulatory landscape around CSV

See What Others Are Saying About Boot Camp

Materials Provided:
Pre-Work Packet, course binder, Delivery and SOP Templates Bundle, lunch and afternoon snack, Certificate of Completion.

Prerequisites:

This course requires you to bring a laptop to class. You will need internet access, a spreadsheet & word processing application and a PDF reader. You will NOT be required to install any software.

Course Number: CS 300

Duration: 4.5 days

Cost: $3,195 per student

Group Pricing: Enroll two students at full price and receive a third seat FREE.

We Are Offering This Course on the Following Dates:

 

Private Session: We can bring this course to you. Save travel costs and select the dates that work for your team. Private classes start at $14,500 for up to twelve (12) students – that’s 62% off full price. Contact Us for larger group pricing, additional questions, or to schedule your session.