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FDA Regulatory Expert Witness Regarding Medical Devices, Drugs, Software and Data Integrity
Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions: 1) What did the…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Pharmaceutical Manufacturing & Packaging: Sterile Pharmaceuticals, Blow Fill Seal, Liquid Filling, Solids Filling, Facilities & Equipment
Pharmaceutical Industry Expert with over 35 years of experience in all aspects of pharma manufacturing and packaging. He is a leader in manufacturing facilities and equipment, with in-depth knowledge of design, construction, start-up, validation, operations, and maintenance. He is an…
Bioprocessing & Biopharma
Expert has 13+ years of experience in Biopharma and Bioprocessing, with R&D, MSAT and manufacturing experience. He is well versed in process development, scale-up to manufacturing, GMP manufacturing, and FDA-approved manufacturing facilities as both a client and customer. He can…
Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
Whole Slide Imaging (WSI), Digital Pathology, and Technical Domains
Expert started in the field of WSI -- whole slide imaging -- when he joined a biosystems company in 2013 as a systems engineer. At that time, the specific imaging business unit he joined was a new acquisition, This technology…
Drug Delivery Modeling
Expert is an independent modeling consultant from Huntsville, Alabama. Until recently, he was a senior principal scientist in CFD Research Corporation (CFDRC), Huntsville, Alabama. He has a strong background in PBBM/PBPK modeling and simulation methods, CFD, scientific computing, mathematical modeling…
Product Development, Mechatronics, Mechanical Engineering, Electromechanical Engineering, Analytical Instrumentation, Machine Design
Expert is an Independent Consultant who advises clients about the Engineering, Design, and Development of complex systems and products. His philosophy is to help clients find the best path for their unique situation. In addition, he is an expert at…
Supply Chain/Procurement – Healthcare Industry
Expert has 20 years of experience in the health care field as a Director of Procurement/Supply Chain. She specializes in multi-site ASC's, IDN, and Hospitals. Experience in contracts, purchasing, vendor relationships, distributor/manf purchasing, GPO (Group Purchasing Organizations) Online purchasing, Neuromodulation,…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…