IVT Network is proud to present this FREE and Informative Webinar, "Computer Software Assurance – A Focus on Critical Thinking," on Tuesday, March 16, 2021 at 1PM EST. This educational offering is in partnership with Agilent Technologies
Regulatory guidance on Computerized System Validation (CSV) has remained consistent for years, with much of the core guidance dating back to the early 2000s. However, in a recent study, the FDA has identified several industry challenges that could be improved upon by eliminating redundancy and focusing on the system’s critical elements. In response to this evaluation, the FDA has agreed to streamline these points with their new and anticipated Computer Software Assurance (CSA) guidance. This update is expected to shift the industry’s focus away from documentation, in favor of a greater emphasis on critical thinking, risk assessments, and testing. Apart from introducing CSA, this presentation will also discuss risk assessments for CSA validations and different types of testing methodology.
- Introduction of Computer Software Assurance (CSA)
- Comparison of different risk assessment methodologies
- Reviewing the importance of critical thinking
- Comparison of different testing methodologies
About Our Speakers
Matt Abrahms, Americas Compliance Application Expert, Agilent Technologies
Matt Abrahms is a laboratory compliance specialist focused on instrument qualifications and computer system validation. He is a frequent speaker at Agilent’s compliance seminars and is a certified instructor for the USP’s performance verification test. He has performed over 100 instrument qualifications in a GMP environment and works closely with Agilent’s customers to comply with new regulatory updates. As a specialist he collaborates with Agilent’s solutions unit and service teams to ensure the quality of Agilent’s compliance delivery.
John Marino, Compliance Consultant, Agilent Technologies
John has over 30 years of experience in regulated environments in the Pharmaceutical, Medical Device and Bio-Tech industries. Three quarters of John's career has been spent on the customer side of the industry in IT, R&D/QC Laboratories and Quality Assurance positions, deploying, supporting and qualifying/validating regulated computerized systems. The other quarter has been spent providing consultative compliance service programs from the vendor side of the industry within Software Quality Assurance. His experience includes supporting/validating both standalone and enterprise laboratory informatics systems, as well as instrument qualification, preventive maintenance, disaster recovery and database migrations. John has held various IT, Lab and Quality Assurance positions at Lederle Labs, Organon Pharmaceuticals, Warner-Lambert and Johnson & Johnson on the customer side of the industry. John has also held a Software Quality Assurance position at Beckman-Coulter and he currently serves as the Compliance Consultant at Agilent Technologies. John holds a B.S. in Biology.