An accomplished quality systems and regulatory compliance professional with more than 25 years of experience and comprehensive knowledge of United States FDA regulatory requirements and industry guidance documents. As a consultant, performed more than 100 projects to support the development, transfer, manufacturing, and distribution of sterile finished products (parenteral, ophthalmic, and inhalation), active pharmaceutical ingredients, combination products, medical devices, pharmacy compounded products, cell culture products, blood and blood products, and HCT/Ps. Breadth of projects includes consultation and in-depth systems gap assessments; systems and process remediations; root cause investigations consultations; third-party audits; third-party review of executed documents to support product distribution; draft responses to FDA Untitled Letters / Warning Letters and FDA Forms 483 observations; product recall management; supplier audits; onsite and offsite training; and investigator and auditor training, coaching, and certification. Examples of project scopes include:• Sterile drug manufacturing sterility assurance gap assessment and recommendations• Process validation gap assessments and quality improvement plan development • Drafted responses to FDA Warning/Untitled letters and FDA-483 that were accepted by the FDA with no comments and / or deficiencies identified• Led investigations and determined root causes for product and process failures, including media fill failures, that have resulted in multiple batch rejections, and / or product recalls• Gap assessments and remediation for Investigation systems; environmental monitoring program; change management system; training program; data governance, and data integrity; equipment and facility cleaning validation; facility qualification and maintenance; and supplier quality management• Pre-approval inspection readiness gap assessments and quality improvement plan development• Quality systems and production and process control procedures development for compounding pharmacy• Developed and executed investigator and auditor coaching and certification programs • Annual quality system audits and CAPA approval, tracking, and effectiveness checks• Supplier quality audits and CAPA approval, tracking, and effectiveness checks• Product recall management and product recall process and procedure remediation• Safety/post-marketing adverse event reporting / complaint handling system audits• Third-party reviewer of executed documents for organizations with FDA OAI status and / or Warning Letter
Listed skills include Gmp, Pharmaceutical Industry, Fda, Quality Assurance, and 23 others.
