Monica Wilkins

Senior Director, Corporate Quality Assurance and Compliance.  Abbott Laboratories.  Prior to joining Abbott, Monica was employed by the Food and Drug Administration (FDA).  Monica held the positions of a Medical Device National Expert, Compliance Officer, Medical Device Specialist, and Investigator.  As a National Expert, her responsibilities included the conduct of domestic and international inspections; providing assistance to all Centers, Districts, Industry, Investigators and other government agencies; development of training curriculum; classroom instruction at the FDA national courses and industry seminars/workshops; on-the-job training for investigators; and assisting in the review and development of policies and guidance documents.  She has twelve years of experience in performing medical device and pharmaceutical inspections for the FDA.  She holds a Bachelors degree in Microbiology from the University of Texas at Austin.