Sue Soderholm is a management consultant at Compliance Architects®. She started in pharmaceuticals and medical devices at Abbott Laboratories prior to the split off of Hospira and AbbVie. She worked in the diagnostics division and the pharmaceutical products division where she gained deep lab and product launch experience, FDA remediation experience, automated software introduction for electronic batch records (EBR) and ran the clinical pilot plant while there. She trained more than 1,000 employees on various critical FDA required remediations activities. Sue also has extensive experience with injection blow molding and flexible packaging working as well as cold chain experience. Sue obtained her Master Six Sigma Black Belt through Villanova University and employs the lean and continuous improvement methodologies in her approach to compliance issues. Her tenure at Hospira/Pfizer combined best practice activity on a global basis to ensure consistency across the company and all sites. Sue graduated from Carroll University with a biology degree and completed her nuclear medicine training in Milwaukee, WI.