Computer System Validation and Part 11 Compliance

Duration: 90 Minutes
Course Instructor

Joy McElroy

$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies must update their systems and processes to maintain compliance.

This 90-minute accredited ON DEMAND training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies outsource IT resources and are involved in Software as a Service (SaaS) and cloud computing.

These vendors are not regulated, and therefore, this course will enable regulated companies to ensure compliance for both infrastructure qualification and computer system validation to avoid FDA form 483s and Warning Letters.

Upon completion of this course, you will be able to:

  • Restate Part 11 requirements
  • Apply Part 11 requirements to Computer System Validation
  • Evaluate current SOPs for Computer System Validation
  • Implement improved security controls through validation
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This course is intended for professionals from the Pharmaceutical, Biologics, Medical Device and related industries who work in the following areas:

  • Quality Assurance/Quality Control
  • Project Management
  • Information Technology
  • System Validation
  • Engineering
  • Manufacturing

Anyone from the above departments that enters data in a computer system, that pulls reports from a computer system, that operates equipment that stores data, engineers, QA and QC analysts, equipment operators, maintenance personnel will find this course beneficial.


Course Instructor

Joy McElroy

Consultant to the Pharmaceutical and Biotech Industries

Joy McElroy’s Courses


Team Training

When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.

Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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