Michael R. Porter

Mr. Porter has over thirty-four years of diverse experience in GxP regulated environments, including a clinical research organization (CRO), pharmaceutical manufacturing, medical device, laboratory, and medical diagnostic businesses providing leadership in quality, operations, and project management with over two of those years spent in quality and regulatory compliance consulting services. He is an experienced quality executive with proven success in developing overarching strategies and creating effective implementation plans that drive efficient and compliant outcomes. He sets a vision for improvement that delivers standardized business processes, useful electronic quality management system tools and reporting, helpful procedures and training, and effective monitoring of the outcomes. He has experience with quality management systems for commercial and clinical uses including deviation management, CAPA, change control, document control, scientific/research misconduct, serious breach, and auditing/regulatory inspection. His leadership strengths include effective collaboration, strategic business planning and the ability to successfully deliver results in multiple business environments, including on-site at an international manufacturing operation and in both new and established business areas.

His areas of expertise include:

• Quality Strategy and Quality Planning
• Quality Management Systems (QMS) development and remediation
• Enterprise Quality Management System (eQMS) deployment
• Inspection readiness preparation, management, and response
• Quality Risk Management (QRM)
• Root Cause Analysis (RCA) and investigations
• Continuous Improvement
• Procedure and Training development
• Auditing and gap assessments
• Quality Metrics and KQI/KPI development
• GxPs including GMP, GDP, GCP
• Operational Quality (e.g., Batch release, clinical trial execution, deviations, change control)