Computer System Validation for Cloud and COTS Applications–Live, Online Training

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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.

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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:

 

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.