Felicia Ford-Rice, Principal Consultant, at PAREXEL Consulting, utilizes over 20 years of R&D, Regulatory Affairs and Quality Assurance expertise to advise clients on the development, implementation and management of quality organizations and quality systems to ensure Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice (collectively, GxP) and Pharmacovigilance compliance. Ms. Ford-Rice provides consulting services on a variety of quality compliance topics including: • GxP Compliance/ Inspection Readiness / Training • Regulatory Risk/ Failure Investigation/ Change Control Evaluation • Corrective Action and Preventive Action /Product Complaint Assessments Ms. Ford-Rice consults with client senior management to develop effective strategies and responses to regulatory authority findings (e.g., FDA 483, Warning Letters, EMA and Health Canada Inspection Observations) and performs verification activities for enforcement sanctions (i.e., Warning Letters, Consent Decrees) and additional activities under attorney-client privilege. In addition, Ms. Ford-Rice performs systems-based audits of sterile and non-sterile, API, pharmaceutical, radiopharmaceutical, and biological manufacturing operations and training on GMP Compliance topics. Prior to joining PAREXEL, Ms. Ford-Rice held positions as Senior Director, Quality Assurance (Astellas), Director, Quality Assurance (Acambis, now Sanonfi Pasteur, and AtheroGenics Inc.), Section Head Quality Control and Standards/Advisor (GlaxoSmithKline, SmithKline Beecham) and served as Adjunct Professor (Part-Time) for Northeastern University. Ms. Ford-Rice is currently a Master of Science degree candidate in Regulatory Science at Johns Hopkins University. She has earned a Master in Management in Business Administration and a Project Management Certificate from Penn State University and holds a professional certification in Regulatory Affairs from the Regulatory Affairs Professional Society. Ms. Ford-Rice completed Management Development and Leadership Executive Education courses at Emory University, and earned a BS in Biology from Virginia Tech. Ms. Ford-Rice has presented on GxP compliance topics at several professional association meetings and is a member of ASQ, PDA, RAPS and ISPE.