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Expert ID: 729549 California, USA

Expert in Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality

Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…

Expert ID: 723693 Florida, USA

Expert in Pharmaceutical Science; Preformulation, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation

As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…

Expert ID: 723903 North Carolina, USA

Expert in 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…

Expert ID: 736123 Indiana, USA

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…

Expert ID: 735020 California, USA

Expert in Pharmaceutical Processing and Packaging

Expert has over 20 years of experience in engineering and technical services. He has lead teams of engineers working in development, material qualification process development/ qualification, as well as lifecycle management for both new and existing combination/ non-combination products. Expert…

Expert ID: 735404 India

Expert in Packaging, Research and Development, Purchase, Supply chain, FMCG, CPG, Food, Healthcare and Pharmaceutical

Packaging Engineer at GSK Consumer Healthcare, India, Handling new pack development and existing business support to packaging/packaging machines for Health Food and Nutrition, Digestive health, Pain, Respiratory and Oral Healthcare products for ISC market. Published patent for innovative packaging concept…

Expert ID: 735397 Connecticut, USA

Expert in Pharmaceutical Development

He brings 38 career-years’ experience, including service at FDA as a Review Chemist. He began his career in pharmaceutical research and development with Purdue Pharma (Stamford, CT – MS-Contin®, Uniphyl®, Oxycontin®)(3 years), and continued on to Bayer (West Haven, CT…

Expert ID: 735389 New Jersey, USA

Expert in Water Treatment Technologies, Water Quality

Expert is a nationally recognized expert in the evaluation of drinking water treatment technologies. He has over 30 years of experience working with municipal water treatment technologies as both a user and researcher. He has made over 100 presentations at…

Expert ID: 733840 Colorado, USA

Expert in Laboratory Management and Development: ISO and Internal Audits, Statistical Process Control, Sampling and Process Improvement

LABORATORY MANAGEMENT AND DEVELOPMENT: Expert managed and developed an analytical laboratory from department side service for basic soil analysis to independent profitable Laboratory unit for soil, plant and water analysis. The laboratory supported research and also performed testing services for…

Expert ID: 732491 Washington, USA

Expert in Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices

Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…

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