- 25 years of US and international experience in pharmaceutical and biotechnology manufacturing and testing, medical devices, and product development.
Quality and Regulatory Compliance Support for Pharmaceuticals, Medical Devices, and Chemical Reagents; Audits; Supplier Qualification; Optimization of Contract Manufacturers, Testing Laboratories, and Suppliers; FDA/European Global Requirements; Product and Process Development; Manufacture of Clinical Trials Materials; Chemistry, Manufacturing, and Controls Support; Development of Procedures and Quality Systems; Training; Scientific Background in Analytical Chemistry, Organic Synthetic Chemistry, Protein Chemistry, Biology, Microbiology, and Biochemistry.
Principal Consultant Drug Quality Assurance, LLC
Quality Assurance: Perform audits (GMP, GCP, GLP, GDP, IRCA-certified pharmaceutical quality management systems lead auditor/GMP lead auditor, ISO 9001 auditor, qualified IPEA excipient GMP auditor) including due diligence for manufacturers, laboratories, suppliers, distributors, CROs, clinical trial sites, and distributors globally in the US, Europe, and Canada; create quality systems and procedures, standard operating procedures (SOPs), and GMP training; provide supply chain management (contract manufacturing organization selection and support); perform batch record review, review, disposition, and batch release; complete investigations, corrective and preventive action; review master validation plans and process validation protocols/reports; perform equipment qualifications; provide quality support of commercial products; create risk assessment programs.
Development – Drug Substance and Drug Product: Create clinical trial materials; oversee technology transfer; perform master batch record and device history record development; create phase-appropriate GMPs and quality systems; execute test method qualification, validation, and protocols; fulfill Chemistry Manufacturing and Controls (CMC); design process validation, preparation for pre-approval inspections, and commercial launch preparations.
Supply Chain Management: Manage supplier qualification, setting up a robust supplier/vendor/contractor qualification system; oversee supplier risk assessment to comply with FDA, European, global expectations as well as create quality agreements.
Regulatory Compliance: Stay abreast of changes and meet new FDA and international rules; prevent and resolve compliance problems and engage in consent decree remediation; create FDA, European, and global inspection response and follow-up.