This on-demand webinar discusses the upcoming CSA guidance and how life sciences companies can and should be applying the principles and methodologies today.
USDM hosted a webinar, Update from the FDA on CSV Changes, with Francisco Vicenty, Case for Quality Program Manager, FDA, discussing the upcoming Computer Software Assurance (CSA) guidance and how life sciences companies can and should be applying the principles and methodologies today. Due to the overwhelming amount of questions we received from 2,000 of your peers, we created this follow-up webinar to answer the many questions we couldn’t address in time.
Join our exclusive Q&A session with Francisco Vicenty to hear questions answered from across the life sciences industry on CSA. You can read the questions and answers on this blog post.
The discussion will include:
- Live Q&A
- What changes to CSV will impact you
- Deeper dive on what CSA means to you
About the Presenters
Francisco Vicenty, Case for Quality program manager, the U.S. Food and Drug Administration
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, Cloud Assurance QA/RA manager, 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 participated in assisting companies with responses to consent decrees and audit findings to the FDA. She is well versed in risk analysis, creation of quality procedures, computer system validation, auditing, and authoring regulatory submissions.
Additional CSA References:
- USDM Services for CSA
- Blog: Top CSA Insights
- White Paper: Regulatory Risk Reduction in the Cloud: Why Cloud Systems Are Safer Than On-Premise Systems
- Blog: Q&A: CSA, CSA, and Why the Paradigm Shift
- Blog: Lessons from USDM’s Cloud Assurance Automated Testing Tool for Box GxP