Regina Fullin

Management Consultant

Regina Fullin is a Senior Compliance / Validation Consultant with Compliance Team, Inc.TM (CTI), where she assists clients in the medical device and pharmaceutical industries to achieve ever-increasing compliance to regulations in the pharma, medical device, and related industries. She has experience assisting with UDI implementations, and has authored several industry articles on the subject of UDI. Regina began her career more than 20 years ago in a Quality role at Abbott Laboratories, and has worked in Quality roles at other companies, including GE Healthcare. Her particular areas of expertise focus on validation, equipment qualification, complaint handling, technical writing and remediation projects for companies requiring compliance assistance. Within her role at CTI, Regina also uses her writing skills to publish relevant and meaningful articles to help medical manufacturers stay current with regulatory changes, industry trends and improve product quality. Regina is active in the American Society for Quality (ASQ), an international non-profit organization devoted to serving the needs of quality professionals. Regina is active in the Northeastern Illinois Section (1212) , and is the Current Chair, having served previously as the Programs Chair. In addition to her Section involvement, Regina also serves on the ASQ Food, Drug and Cosmetic Division, where she participates in conference/event planning and annual audit. Regina is also a Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) and a Certified Manager of Quality-Organizational Excellence (CMQ-OE) with ASQ.

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The UDI compliance date for Class II devices sold in the U.S. is coming! By September 24, 2016, all Class II devices need to be marked with a UDI. With the volume of Class II medical devices marketed in ...

The FDA finds inadequacies in process validation for Medical Device firms at an alarming frequency. In fact, the fourth most frequently-cited Form 483 observation for medical device firms is for Process Va ...