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?

Webinar Takeaway

  • 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 Will Benefit

  • 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.
Faculty Carolyn Troiano

Faculty Carolyn Troiano

Midlothian, Virginia, United States

Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity

My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.

My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.

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