New FDA guidance “Computer System Assurance” and Agilent Validation Service Offerings

The FDA guidance for Computer System Assurance (CSA) is intended to reduce the time and effort of the Computerized System Validation (CSV) process without compromising regulatory compliance or data integrity.

The regulated life science industries generally consider the CSV process as burdensome and as a hindrance to adopting new automation technologies that could greatly improve the efficiency and productivity of their business. In this presentation we will examine the six major points of the CSA guidance and how they can be used to improve your CSV process. We will also examine Agilent’s validation services, our process efficiencies, and how we intend to integrate elements of the CSA guidance.

Presenter: Michael Korbel (Sr. Compliance Consultant, Agilent Technologies, Inc.)

Michael has over 22 years of experience in regulated environments in the pharmaceutical and bio-tech industries. Half of Michael's career has been spent on the customer side of the industry in both IT and laboratory positions, supporting, qualifying, and validating regulated instruments and computerized systems. The other half has been spent providing consultative compliance service programs from the vendor side of the industry. His experience includes technical support and validation of both standalone and enterprise laboratory informatics systems, as well as instrument qualification, preventive maintenance, and relocation services. Michael’s current role at Agilent Technologies is to create new compliance consulting services for our regulated customers and implement them globally. Michael holds a B.S. in Biology, with minors in Chemistry and Environmental Science.