Computer System Validation for Cloud and COTS Applications–Live, Online Training
Course Description:
Most companies today are buying, rather than building, the computer systems that they use in their GxP-regulated activities. However, for pharmaceutical, biotech, medical device, and similar companies, computer system validation (CSV) is still required. But CSV responsibilities and approaches have changed.
Whether your solution is cloud-based, SaaS, COTS (commercial-off-the-shelf), or OOTB (out-of-the-box), this seminar has been designed to ensure that you leave knowing what to validate, how to validate, and when to leverage vendor-supplied documentation in your validation. You will also learn the necessity and power of vendor assessments and risk-based validation.
This computer system validation course incorporates FDA, ICH, and Eudralex expectations for risk-based computer system validation, and aligns with industry-wide standards, such as those defined by GAMP and PIC/S.
Download the Course Brochure See the Agenda
Our Approach to Computer System Validation Training:
Our experienced computer system validation consultants have designed a concise, yet thorough course to equip you with the information you need to validate purchased applications. A mixture of instructor lectures, class activities, and real-world examples will keep you engaged. And, there will be plenty of opportunities to get answers to your company-specific questions.
What You Get:
- Knowledge of the many models of cloud implementation, e.g., SaaS, PaaS, IaaS
- Understanding of appropriate validation approaches for cloud (e.g., SaaS) and purchased (e.g., COTS) systems
- Recognition of the company and vendor responsibilities that occur when implementing purchased (e.g., COTS) system and Cloud solutions
- Appreciation for the increased importance of vendor assessments, the methods of vendor assessments, and how these assessments impact your validation approach
- Comprehension of which software does and does not require validation.
- Understanding of the purpose and required contents of all validation deliverables, including Validation Plans, Requirements Specifications, Validation Tests (IQ, OQ, PQ), Trace Matrices, and Validation Reports
- A walk-through of a complete package of validation deliverables for a configured, off-the-shelf system.
- A methodology for system risk assessment and an implementation model for risk-based computer system validation
- Awareness of what it really takes to be 21 CFR Part 11 and Annex 11 compliant
- Data and examples of common FDA Warning Letter topics regarding software validation and system quality
Who Should Attend CSV for Cloud and COTS Applications?
IT, QA, Engineering & Business Managers and Professionals who need to:
- Manage computer system validation projects
- Approve CSV project deliverables, such as validation plans, requirements documents, validation protocols (IQ, OQ, PQ), trace matrices, and validation reports
- Audit computer system validation processes and documents
- Assess software vendors’ quality assurance practices prior to purchasing systems for use in GxP activities
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Materials Provided:
Course binder, example validation package, Certificate of Completion
Duration: 16 hours
C0st: $1599 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:
Computer System Validation for Cloud and COTS Applications (Live, Online – EU)
November 11 - November 13Computer System Validation for Cloud and COTS Applications (Live, Online – US)
December 9 - December 11Computer System Validation (CSV) for Cloud/COTS – USA – January 2025
January 13, 2025 @ 10:30 am - January 15, 2025 @ 4:00 pm CSTComputer System Validation (CSV) for Cloud/COTS – USA – April 2025
April 7, 2025 @ 10:30 am - April 9, 2025 @ 4:00 pm CDTComputer System Validation (CSV) for Cloud/COTS – EU – May 2025
May 12, 2025 @ 10:30 am - May 14, 2025 @ 4:00 pm CEST
Private Session: We can provide this course at a date and time that works best for your team. Private seminars start at $7,300 for up to twelve (12) participants – that’s 62% off full price. Contact Us for larger group pricing, additional questions, or to schedule your session.