N. Brent Conatser

Accomplished professional in the areas of Regulatory Compliance, Quality Assurance, and Regulatory Affairs working for the FDA and top tier pharmaceutical companies (Pfizer, J & J and Lilly). Extensive technical and management experience in developing, implementing and administering compliance programs supporting GXP operations from formulation development to post market surveillance. Extensive interaction experience with FDA and other international authorities. Assisted numerous global manufacturing sites in preparation for FDA, EMEA, and various national authority inspections. Successfully managed the design, implementation and on-going support of both development (GLP/GCP) and commercial (GMP) quality management systems for global application. Experience with managing staff in different geographic locations and interacting with quality, technical and business leaders at company sites and contract manufacturers worldwide. Experience in all aspects of building and executing a global quality audit program. Possess excellent communication and negotiation skills. Specialties: Regulatory Compliance Inspection Readiness API and Finished Dosage Forms Global PV Complaint Investigations Quality Due Diligence Assessments Facility Audits Data Integrity Strategy Development Auditor Training Program Development Regulatory Inspection Responses Inspection Interaction Training Coaching and Mentoring GMP Gap Assessments Site Quality Plan development and management Change Agent