Frances Gavigan

Expert Quality Assurance and Quality Management System (QMS) professional with direct GLP, GCP and PVG inspection, auditing and oversight experience in diverse (FDA/EPA) regulatory environments. Extensive auditing and study oversight experience, i.e. vendor labs, CROs, business partners and Pharmacovigilance and Safety Vendors. Direct FDA, sponsor and business partner inspections (GLP, GCP and PVG), QMS and Corrective and Preventive Actions (CAPA) plan development, implementation and closure. Collaborative and adaptive team member with proven communication, training, and inspection management skills, capable of working independently or in a team. A problem solver and resource for R&D, Regulatory and Business Unit management providing an FDA insider’s perspective on regulatory requirements and strategies for drug development and approval. Expertise : Standard Operating Procedures , Policies, Quality Systems Analysis and assessment. Expert Regulatory Compliance Investigator/Audits Quality Management System (QMS) Development Regulatory Inspection Readiness/CAPA Management CRO/Vendor/Site/Partner Qualification Assessment Gap Assessment & Post Inspection Responses GxP Risk Identification, Mitigation and Management Cross Functional/Organizational Problem Solving Published Researcher and Technical Writer