Webinar Summaries And Links

Supplier Process "Line Down" - Investigation Walkthrough Using SPC
This presentation is an actual case study and will walk through a situation where Statistical Process Control (SPC) was used, after-the-fact, to assess a supplier’s problem with a critical heat-seal process. While SPC did not identify the root cause, an analysis of the historical data from this long-running process brought to light, to both the customer and the supplier, inappropriate acceptance criteria and unrecognized output variability. The study shows the value of SPC when applied to processes with output that can only be measured with destructive testing. Link to slides. Link to recording.


Summary of three part series on Computer Software Assurance

This recording documents the first of a three part series. The presenters provide information on a new FDA Guidance Computer Software Assurance guidance document due for release in 2022 and how the change from Computer Software to Computer Software Assurance will streamline a risk-based approach to the software approval process will provide better quality, lower cost, and reduced development time. Here's a link to a CSA whitepaper.

This recording documents the second of the three part series. This session is an actual case study from Johnson and Johnson and provides valuable information on actual implementation of CSA. Here's a link to the presentation.
This recording is a session that documents actual case studies of conversion from Computer Software Validation to Computer Software Assurance (CSA) at Medtronic and Lantheus Medical Imaging. It provides valuable information on actual implementation of CSA and the quality and economic benefits of the conversion. Here's a link to the slides.


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