A Practical Examination of How to Use Risk Assessments in the CSV Process Webinar

Learning Level: Intermediate

Risk Assessments are a core part of regulatory compliance, but many lab organizations struggle to properly scale their Computerized System Validation (CSV) activities based on these detailed assessments. Our presentation will analyze the value of risk assessments related to Computerized System Validation and Data Integrity activities with consideration of the current lockdown environment. This will be followed by examples of practical risk assessment approaches where we will discuss the pros and cons of each to assist in methodology selection. Lastly, we will show how to implement the results of a risk assessment to provide value and efficiency to the audience’s Computerized System Validation activities.

Learning Objectives

  1. The value of risk assessments to the CSV process
  2. Comparison of different risk assessment methodologies
  3. How to leverage the results of the risk assessment to “right-size” your compliance activities


A Practical Examination of How to Use Risk Assessments in the CSV Process


Michael Korbel
Global Sr. Compliance Consultant on the LED Marketing Team
Paul A. Smith
Global Strategic Compliance Specialist
Agilent Technologies

Event Sponsor

Agilent Technologies

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