Learn what the FDA’s new Computer Software Assurance (CSA) approach means for regulated life sciences companies.
Feedback from our Forward-Thinking GxP Compliance & Process Optimization event in January indicated that many in the industry wanted to learn the fundamentals of CSA. Sandy Hedberg fulfills that request in this on-demand webinar.
USDM has been applying a CSA methodology with our clients for more than a year. In this webinar, we explain the intentions and principles for the guidance and why this simplified, risk-based approach to Computer System Validation (CSV) can be applied to IT systems today.
For a webinar geared toward life sciences professionals new to the industry or pre-commercial companies selecting their IT systems, watch An Introduction to Computer System Validation.
This discussion of CSA includes:
- Why the FDA is moving from “validation” to “assurance”
- What CSA means to regulated life sciences companies
- What is different from the traditional CSV
- Case studies from companies that have transitioned to CSA
Presenter
Sandy Hedberg, Director, Quality and Regulatory Affairs, USDM Life Sciences
Sandy has more than 30 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, creating quality procedures, computer system validation, auditing, and authoring regulatory submissions.
Additional Resources
- Video with Cisco Vicenty of the FDA: FDA Perspectives on Cloud Technologies
- White Paper: Considering CSA? Here's what you need to know
- Case Study: Pharmaceutical Company Transitions to CSA Model with USDM Expertise