Diane Gleinser is the Vice President of Life Sciences and Solutions at USDM Life Sciences.

Diane has over 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 sciences 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.

She holds a B.S. in Biology from San Diego State University and a Certification in Pharmaceutical and Medical Device Law from Seton Hall University.

Fun Fact

Diane worked as a commercial fisherman before becoming involved in the life sciences industry. She has two children and eight grandchildren all living close by who have all learned to love fishing.

Diane's Recently Published Content

White Paper and eBooks
Considering CSA? Here’s what you need to know
Cloud Compliance and the Future of Computer Software Regulation

How to Get Results on Regulated Projects with Virtual Teams

Adapting Computer System Validation to Accommodate Evolving FDA Guidance

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