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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.  
 

What we discussed:

  • Changes coming to Computer System Validation
  • The FDA’s urging companies to use automation in their manufacturing process 
  • CSA approach vs. CSV  approach


"There's really no need for the pharmaceutical industry or the biological and biologics industries to not take advantage of a more streamlined and effective approach right away.”
— Diane Gleinser


About the Speakers:

Diane Gleinser
, VP of Life Sciences Solutions, USDM Life Sciences
Diane has three decades of experience in the life sciences industry and leads a highly skilled team of implementation and compliance engineers. Her in-depth knowledge of the regulatory landscape and unwavering passion has been instrumental in rooting USDM's focus on regulatory compliance for life science customers. Over her tenure, Diane has mastered quality assurance, quality control, validation and regulatory compliance for R&D, clinical affairs, manufacturing and packaging, laboratory setup and analysis, and auditing under cGMP, cGLP, and cGCP regulations and 21 CFR Part 11.

Sandy HedbergCloud 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. 
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