As the Life Sciences adapt to manufacturing amidst Covid-19, the FDA is also updating guidelines for computer system validation. So, what does this mean for your organization? Diane Gleinser and Sandy Hedberg discuss the intricacies of the new guidance, and how you will need to adapt when it comes to showing evidence that the computer systems you're using comply with the predicate rules.
Diane has an impressive background in the Life Sciences, and brings her experience, knowledge, and her certification in medical device and pharmaceutical law to USDM and the industry as a whole.
Diane Gleisner , VP Life Science Services and Solutions
Sandy Hedberg QA/RA Manager, Cloud Assurance at USDM Life Sciences
What we talked about:
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