How Will FDA’s New Approach to CSV Make Implementations Easier?

There is a big shift in the computer system validation (CSV) strategy coming from the FDA. The new methodology and guidance called Computer System Assurance (CSA) could be in place before January 2021. Its focus is taking the principles from Quality Risk Management and applying that same logic to computer systems. In this webinar, we will dissect the new CSA approach and explore the key matrices/tools needed to make solid risk determinations thus providing the framework needed to streamline computer platform implementations and on-going maintenance.

In the final analysis, there are key questions that must be applied for CSA to be effective. Does the software impact patient safety? Does this software impact product quality? How does this software impact your quality system integrity?

Areas Covered in the Session :

  • What is Computer Software Assurance for Manufacturing, Operations and Quality Systems Software?
  • What is critical risk thinking?
  • Understand the differences between CSA and CSV model.
  • What computer systems does CSA apply?
  • What performance metrics do I need?
  • When do I need to be prepared for the new approach and final guidance / regulations?
  • Where to start in your transition and next steps?

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Information Technology Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Software Developers
  • Laboratory Managers
  • Automation Analysts
  • Supply Chain Departments
  • Clinical Data Professionals
  • Computer System Validation Specialists
  • Documentation Departments
  • Training Departments
  • This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

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Carolyn Troiano

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance