What does the computer software assurance approach mean for regulated life sciences companies?
Learn from the FDA’s Francisco Vicenty about what the upcoming Computer System Validation (CSV) guidance is and get clarity on what the “Computer Software Assurance” approach means for regulated life sciences companies. The FDA will explain the intentions and principles for the guidance and why this simplified, risk-based approach to CSV can be applied to IT systems today.
The discussion will include:
- Why the FDA is moving from “validation” to “assurance”
- What Computer Software Assurance means to you
- Examples of risk evaluation and acceptable records
- Live Q & A
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.
The questions and answers from this webinar are documented for you here: Q&A: CSV, CSA, and Why the Paradigm Shift.
Additional CSA References: