Lorrie Divers

About Lorrie Divers

Professional Expertise: GCP Regulatory Compliance | Quality Compliance-Vendor Management | Clinical Quality Assurance | GCP & GCLP Audits and Compliance | GCP Inspection Strategy | GCP Process Development and ImprovementProfessional Profile: I am a career quality assurance, quality management and clinical research professional with a pragmatic approach to integrating exceptional compliance standards with operational realities to drive business success. From an experience standpoint, I am a strong practitioner, consultant, individual contributor and leader-manager with comprehensive skills, understanding and experience in all operational areas of clinical research and development, quality management, regulatory compliance and staff training. In whatever role, colleagues and clients would find me to be agile and nimble with the unique ability to interpret, explain and apply regulations to realize risk-based, data-driven improvements to quality, efficiency and compliance. Core Competencies: FDA, ICH, MHRA and EMA GCP; HIPAA/GDPR; ISO; NYSDOH; CAP/CLIA Quality Management, GCP, GCLP and Regulatory Compliance Auditing, Training Risk Assessment, CAPA Management Metrics Definition and Analysis Process Development, Process Improvement Change Management, Sustainable Compliance Vendor Assessment, Selection and Management Pharmaceuticals, Medical Devices, Biologics, Biosimilars, Laboratory Therapeutic Areas: Oncology, Vaccines, Ophthalmology, Pediatric StudiesGCP Expertise: Quality Management Systems (QMS): Adept at risk-based approaches to developing, managing, assessing & improving QMS, applying the current regulatory environment and predictive trends. Vendor Qualification and Oversight: Skilled at assessment, audit, oversight and incident management, including clinical and bioanalytical laboratories, CROs, central IRBs, niche service providers, and IT products and services. Audit and Compliance Management: Extensive and wide-ranging audit experience, including sponsors, vendors and study sites with a specialization in evaluating study sites and monitoring to provide early intervention to manage risks. Regulatory Authority Inspection Readiness: Direct experience facilitating regulatory authority inspections at the sponsor, CRO, central laboratory and study sites. Staff Training and Development: Proficiency in developing and delivering custom training on GCP topics.Let\'s Connect:I am always eager to network with similar professionals to explore mutual opportunities. Reach me via LinkedIn or email at L••••••••@gmail.com

Experience

1. President

   Qrcp Solutions, Inc

   Mar 2017 — Present · Fort Myers, FL, US

   Founded and manage clinical research and development advisory firm specializing in quality assurance, regulatory compliance, process excellence consulting and contract services for the clinical research and development and related business sectors. Select engagement history: Process improvement. Addressed a client issue where the CRO had a back log of external and internal audit-related corrective and preventive actions (CAPA) related to out-of-date procedures & procedural gaps—risking regulatory non-compliance. Identified the root causes and implemented a comprehensive project plan for all QA-related tasks, assigned responsibilities, timelines and deliverables. Revised existing and/or developed new core QMS procedures to address all CAPA commitments in alignment with current regulations and guidance. Provided GCP training to support understanding of CAPA management and resolution. Successfully met all deliverables within the specified six-month period. Process innovation. Performed a GCP gap analysis for a GLP laboratory seeking to pursue opportunities utilizing their specialty non-diagnostic testing. Reviewed the organization’s existing policies, procedures and work instructions against FDA GCP regulations and guidance in light of the organization’s plan to develop and conduct testing related to Phase 2 and Phase 3 clinical trials. Developed detailed recommendations and a prioritized action plan for ensuring regulatory compliance and QMS. Delivered a go-forward project plan that earned high praise for practicality and risk-based sequential approach.

Education

• University of Rochester

  Bachelor of Arts - BA, Anthropology

Skills

• Oncology
• Protocol
• Vaccines
• Medical Devices
• Clinical Research
• Gcp
• Biotechnology
• Pharmaceutical Industry
• Clinical Development
• Fda
• Quality Assurance
• U.s. Food and Drug Administration (Fda)
• Regulatory Affairs
• CRO
• Clinical Trials
• Good Clinical Practice (Gcp)