Hear directly from the FDA, and get clarity on the new CSA draft guidance.
The FDA issued its draft of the Computer Software Assurance (CSA) Draft Guidance for comments on September 13, 2022. Industry professionals are invited to provide comments for 60 days.
USDM has been studying, training, and implementing this risk-based CSA methodology for our customers for a few years. In this on-demand webinar, our panel of experts, including Francisco Vicenty, Program Manager, Case for Quality, FDA, discussed the draft and any changes and implications impacting medical devices, pharma, and biotech organizations.
The discussion included:
- What is different from the traditional CSV approach
- What CSA means to regulated life sciences organizations
- Learn how you can use automated testing as part of your CSA methodology
- Get answers to frequently asked questions
See the responses to two frequently asked questions about CSA below.
Is CSA just for medical device companies? See the FDA’s Francisco Vicenty’s response to this question.
Francisco discusses the CSA Value Proposition:
To view more frequently asked questions about CSA, read this blog.
Francisco Vicenty, Case for Quality Program Manager, FDA
Cisco Vicenty is currently the program manager for the Case for Quality (CfQ) within the Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA. The Case for Quality has been a strategic priority to improve device quality, access, and outcomes for patients. Cisco has worked as a manager within compliance at CDRH and previously worked in quality and reliability within the semiconductor industry.
Sandy Hedberg, Director of Quality & Regulatory Affairs, USDM Life Sciences
Sandy Hedberg has over 20 years of experience in Quality and Regulatory Affairs in the medical device, pharmaceutical, and biologics industries. She has assisted companies with responses to consent decrees and audit findings to the FDA. She is well versed in risk analysis, the creation of quality procedures, computer system validation, auditing, and authoring regulatory submissions.
Diane Gleinser, VP of Life Science Services and Solutions, USDM Life Sciences
Diane has over three decades of experience in the life sciences industry and leads a highly skilled team of implementation and compliance engineers. Her in-depth knowledge of the regulatory landscape and unwavering passion has been instrumental in rooting USDM’s focus on regulatory compliance for life sciences customers.