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Quality Systems Management

Abigail Davis possesses over 20 years in the industry including experience ranging from large, publicly- traded, highly-regulated companies to small, privately-owned, less-regulated companies. After graduating from University of Wisconsin – Madison in the 1990s, Davis worked in small contract labs conducting food testing and sterility testing on consumer products and medical devices. After those experiences, she joined Abbott Laboratories in northern Illinois. During her time at Abbott, Davis worked in multiple divisions, including the Diagnostics and Molecular divisions and she also worked in Corporate Quality and Regulatory. During her time with Abbott, she worked in a number of different functions and performed a large array of activities including manufacturing IVD products, QC testing products, qualifying manufacturing equipment. She also executed process validations, conducted internal and supplier audits, and hosted FDA inspections. Daivs currently works at Promega Corporation as a senior manager overseeing the quality system. She holds a master’s degree in Biotechnology from the University of Wisconsin – Madison.

Valerie Followell

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Currently teaching:
Medical Device Regulations

Valerie Followell has more than 20years of experience in regulated industries. She currently provides consulting services through Followell Compliance Consultants, LLC. Prior to starting her own firm she was the director of regulatory affairs for Medline Industries. Over her career she has managed regulatory affairs teams for Teleflex Medical and Hospira as well as holding both quality and regulatory positions in drugs, biologics and devices at Baxter Healthcare. Followell received her MBA from Webster University, St. Louis.

Jeffrey Sartain

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Currently teaching:
Practical Quality Management

Jeffrey Sartain is a senior consultant providing quality system, regulatory compliance and general business subject matter expertise and project management services to health care product manufacturers. He has more than 30 years of experience within the medical device, diagnostics, pharmaceutical and food sectors, encompassing roles in quality and regulatory, engineering, and manufacturing, including international regulations and standards. Sartain's areas of expertise include compliance, quality system development and remediation, GxP, supplier/3rd party contract manufacturing controls, CAPA, complaint handling, and product development/transfer. Sartain earned a master's degree in manufacturing engineering from Northwestern University and has earned prior certifications as Quality Manager (ASQ), Lead Auditor (Stat-A-Matrix), Quality Systems/GMP (AAMI), and in Quality Engineering (ASQ).

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