Summary of Experience William H, Fleming, III, PhD has thirty five plus years in the plasma, biopharmaceutical, medical device, contract manufacturing and hospital based clinical industries. He specializes in operations management and quality systems for active pharmaceutical ingredients, finished plasma derived drug products, medical devices, small molecule sustained release microsphere based drug products, biological products, clinical and hospital based reference laboratories. He has extensive experience in all aspects of manufacturing, validation, quality control, quality assurance in a GXP environment and in hospital based laboratories. Dr. Fleming has held numerous positions of increasing responsibility in industry, from the research bench to upper management. He has been successful for building several successful reference businesses and specializes in helping operations build scalable quality systems, IT systems and organizations. Key document types authored: BLA (Small molecules, large molecules, and blood products), Comparability Protocol and final Reports, Process Validation Protocols and Final Reports, Analytical Methods Validation Protocols and Final Reports, FDA 483 Responses, Quality documents to meet ICH Q10, and Microbiology documents (EM Programs and Reports). Audit lead for inspections by the FDA and European Regulatory Agencies (MHRA, EMA, and PMDA).

Highlights:

• Regulatory Compliance
• Regulatory Affairs
• Regulatory Compliance Auditing
• Analytical Chemistry
• Method Validation
• Process Validation
• Microbiology
• Standard Operating Procedures
• CMC BLA 510K
• Policies and Procedures