PDA Metro Chapter Vendor Night - Inspection Hot Topics

Ricki A. Ricki A. Chase is an Executive Director in the Compliance Practice at Lachman Consultants, who has 16 years of experience at the U.S. Food and Drug Administration. Ms. Chase is an expert in Food and Drug Law, Compliance Law, and Current Good Manufacturing Practices. She has served in leadership development in all regulated program areas, including pharmaceuticals, medical devices, human and animal foods, biomonitoring, veterinary medicine, biologics, and imports. As Director, Investigations Branch at FDA, she led the operations of the Investigations Branch, including inspections, special investigations, sample collections, consumer complaints, import operations, and emergency response programs.

Ms. Chase has made numerous presentations including "New Initiatives of FDA, Office of Regulatory Affairs" at ASQ, annual presentations regarding field activities, compliance activities and trends in medical devices and drug program areas at Association of Food and Drug Officials, and compliance law and field activities at John Marshall Law.

While at Lachman Consultants, Ms. Chase has developed, lead and provided expertise in projects including remediation of FDA-483s and Warning Letters, Compliance Enhancement Plans, FDA readiness, cGMP and QSR audits and remediation of Part 4 compliance matters including, corrective actions for Part 820 gaps in combination products, specifically device design.