FDA cited a firm for resuming sterile filling after a 5-week shutdown without conducting a […]
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Experienced professionals with manufacturing, quality assurance and regulatory affairs expertise in pharmaceuticals and medical devices.
Jamie is a private equity investor with operating experience leading teams in highly regulated industries including pharmaceuticals, medical devices, and aerospace.
Jamie Schleck
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Dina Kisver has operating experience as Vice President of Quality for a manufacturer of active pharmaceutical ingredients. She holds an MS degree in Quality Assurance and Regulatory Affairs from Temple University.
Dina Kisver
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An alarming and recent 483 highlights FDA’s continued scrutiny of data integrity issues concerning the […]
In most compliance training programs, employees are taught what to do: follow SOPs, complete forms, […]