Jeri L. Weigand
Medtronic
Sr. Principal Clinical Quality Specialist
<b>Jeri L. Weigand</b> is currently a clinical quality auditor, working for the Medtronic Clinical Research Institute, Medtronic, Inc. in Fridley, Minnesota. Prior to this role, she was a corporate quality system auditor at Medtronic, auditing internal and external manufacturing and lab sites in the US and globally. She previously spent thirty years working for 3M Pharmaceuticals in various capacities, most recently, working as an auditor for 3M Pharmaceuticals in St. Paul, MN, conducting audits in the area of Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practice (GMP). She is a Certified Quality Auditor through the American Society for Quality (ASQ) and a Certified Clinical Research Professional through the Society of Clinical Research Professionals (SOCRA).
Weigand has also worked in the clinical trial materials arena and as a compliance coordinator in the areas of compliance monitoring, cGMP/SOP training, and development and implementation of a division-wide GMP training program, SOP system, calibration system, and laboratory glassware labeling system for the development and analytical groups of 3M Pharmaceuticals.
Weigand is the founder and past chair of the Midwest Clinical Supply Discussion Group, past chair and member of the ISPE Clinical Materials Advisory Group, and current co-leader of the ISPE Training Advisory committee. She has been a workshop coordinator and leader for many national meetings and has co-authored a Pre-NDA Approval Inspection Checklist, a paper on Definitions and Controls for Labeling of <i>Clinical Trial Materials and Clinical Supply Operations</i> and the first edition of the <i>Clinical Trial Materials Training Guide.</i> Weigand has also authored a chapter on <i>Training of Clinical Trial Material Personnel</i> for the Second addition of the <u>Drug Products in Clinical Trials.</u>
Weigand has a BS in education from Northwest Missouri State University, Maryville, MO and a Masters in Organizational Leadership from The College of St. Catherine, St. Paul, MN.
Weigand has also worked in the clinical trial materials arena and as a compliance coordinator in the areas of compliance monitoring, cGMP/SOP training, and development and implementation of a division-wide GMP training program, SOP system, calibration system, and laboratory glassware labeling system for the development and analytical groups of 3M Pharmaceuticals.
Weigand is the founder and past chair of the Midwest Clinical Supply Discussion Group, past chair and member of the ISPE Clinical Materials Advisory Group, and current co-leader of the ISPE Training Advisory committee. She has been a workshop coordinator and leader for many national meetings and has co-authored a Pre-NDA Approval Inspection Checklist, a paper on Definitions and Controls for Labeling of <i>Clinical Trial Materials and Clinical Supply Operations</i> and the first edition of the <i>Clinical Trial Materials Training Guide.</i> Weigand has also authored a chapter on <i>Training of Clinical Trial Material Personnel</i> for the Second addition of the <u>Drug Products in Clinical Trials.</u>
Weigand has a BS in education from Northwest Missouri State University, Maryville, MO and a Masters in Organizational Leadership from The College of St. Catherine, St. Paul, MN.