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Quality Systems Management

Valerie Followell

Email Valerie Followell

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

Email Jeffrey Sartain

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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