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: Computer Software Assurance (CSA) Guidance. Here's what you need to know
- Blog: Q&A: CSA, CSA, and Why the Paradigm Shift
- Blog: Lessons from USDM’s Cloud Assurance Automated Testing Tool for Box GxP
You can also download our datasheet for more information on CSA.
What you'll learn
- Hear an exclusive Q&A session answering questions submitted from across the life sciences industry on CSA.
- Find out what changes to CSV will impact you.
- Go deeper on what CSA means to you.
- Follow up on the questions we couldn't address in time during the original "Update from the FDA on CSV Changes" webinar.
This is an on-demand follow-up Q&A webinar created because of the overwhelming number of questions received from 2,000 of your peers during the original session. It's for life sciences professionals who want to hear questions answered directly by the FDA's Francisco Vicenty alongside USDM's Sandy Hedberg.
FAQ
What does this on-demand session cover?
This on-demand webinar is an exclusive Q&A session answering questions submitted from across the life sciences industry on CSA. The discussion includes a live Q&A, what changes to CSV will impact you, and a deeper dive on what CSA means to you. It was created as a follow-up to answer the many questions that couldn't be addressed in time during the original "Update from the FDA on CSV Changes" webinar.
Who should watch?
This session is for life sciences professionals who submitted or share the questions raised by the 2,000 peers who attended the original webinar and who want to hear them answered directly.
Who presents this session?
The Q&A features Francisco Vicenty, Case for Quality Program Manager at the U.S. Food and Drug Administration, and Sandy Hedberg, Cloud Assurance QA/RA manager at USDM Life Sciences.
How can I watch it?
This is an on-demand webinar you can watch any time. You can also read the questions and answers on this blog post or contact us to talk with USDM.
Where can I learn more from USDM?
Related USDM resources: Computer Software Assurance (CSA), Data Integrity in Life Sciences, 21 CFR Part 11 Compliance, USDM Cloud Assurance, and Contact Us.
Want to talk it through with USDM? Contact our team to watch this on-demand session and continue the conversation.