COURSE ID 2497

Computer System Validation: Rules and Tools

For Today’s IT Professionals, Quality Staff Users

AVAILABLE Live
Date(s) and Time:
May 15, 2024 - May 17, 2024
12:30pm EDT - 5:00pm EDT
Duration: 12 Hours

Can't attend the live course?
Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

Philip E. Sax

Early-Bird Offer

Limited Availability until April 25, 2024

$ 2130
Price
$ 2330
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

For decades, the FDA and International regulatory agencies have been very concerned about the increased use of computer systems for reporting, clinical trial analysis, and communication.

Early validation guidance is focused on processing and reporting. However, today the industry is dependent on the use of computer systems. Developments in areas such as Artificial Intelligence, computer-controlled processing, manufacturing, devices, and inventory systems require sophisticated computers, trained users, skilled IT professionals, and involved management.

This training will include the most recent 2022 FDA draft guidance Computer Software Assurance for Production and Quality System Software. This program provides both national and international requirements and the techniques needed to meet today’s challenging environment. Topics include FDA, GAMP, ISO, MDD, Risk analysis, and more.

This intensive, accredited course is designed to provide an overview of the various aspects of computer validation including best practices, US and International regulations, and Industry expectations. It addresses the rules, tools, and techniques to develop and provide the basis for compliance and implementation for a single system or a company‐wide program and process.

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

  • Explain regulatory requirements and how to comply
  • Describe the effective use of GAMP5
  • Implement the use of risk assessment tools
  • Initiate the necessary steps to comply with Part 11
  • Develop a validation plan
  • Summarize requirements planning
  • Describe and initiate a Validation SOP
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This course is intended for professionals in the pharmaceutical and other life science industries working in all facets of computer systems. The course addresses the responsibilities, roles, tasks, and acceptable techniques associated with the following personnel:

  • System Users
  • Auditors
  • Quality Assurance and Control Staff
  • IT Professionals
  • Project Managers
  • System Vendors
  • Regulatory Staff
  • System Developers, Designers, and Integrators

Course Instructor

Philip E. Sax

Consultant to the Life Science Industry

Philip E. Sax’s Courses

Accreditation

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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