Rosanne Sylvia-Heeter is the Director of cGMP Compliance at Polaris Compliance Consultants, Inc. and has over 30 years of GMP, GLP, and GCP quality assurance and compliance experience with Active Pharmaceutical Ingredients (APIs), clinical research materials, and finished product.  During her career, she has developed global quality systems and prepared both domestic and international facilities for FDA pre-approval inspections.  Ms. Sylvia-Heeter has interacted with the FDA at both the headquarters and district levels.  She has held positions as compliance manager, quality assurance manager, and global director at major research-based and generic pharmaceutical companies and consulting firms.  She is a member of American Society of Quality, Regulatory Affairs Professional Society, and the North Carolina Regulatory Affairs Forum.  Ms. Sylvia-Heeter holds a BS in Biology from Loyola University.