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ID: 739165 Georgia, USA

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…

ID: 736949 India

Packaging Development and Materials

Packaging Technologist / Packaging Consultant / Packaging Engineer based in India having more than 16 years of experience with MNCs like Ranbaxy Laboratories, Fresenius Kabi (Dabur), Jubilant Organosys & Avantor Inc (JT Baker). Also experienced as Visiting faculty and Trainer…

ID: 737241 Washington, USA

Medical Device Engineering

Collaborative and results-oriented medical device engineer with extensive new product development experience. Superior record of delivering results through teamwork, innovation, and focus. Versatile team member having experience in marketing, mechanical engineering, manufacturing, and project management. 47 patents in medical device…

ID: 736602 Georgia, USA

Cost-Effective Clean Energy-Based Technologies, Small Molecules, Polymers, Nanomaterials; Quality Management

Overview: - R&D/Quality/Manufacturing Scientist/Manager with over 20 years of cumulative development/manufacturing/product launch/process scale-up/project management experience involving advanced materials/devices/technologies at chemical/optoelectronic R&D and Manufacturing facilities. - Passionate in coordinating continuous improvement efforts with cross-functional teams at all levels of the organization…

ID: 723693 Florida, USA

Pharmaceutical Science; Preformulating, 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…

ID: 723903 North Carolina, USA

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…

ID: 736481 Illinois, USA

3D Printing, 3D Scanning, Additive Manufacturing, Products and Services

Division Leader – Effective Technology Consultant – Product Value Identification - Strategic Planning – Direct Contributor – New Product Development – Market Analysis Productive Group Leader with expansive experience as Sales Team Executive, AM Product Expert, Direct Contributor, and Project…

ID: 736123 Indiana, USA

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…

ID: 733713 Texas, USA

Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.

. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…

ID: 735010 Texas, USA

Lean Business Process Improvement and Business Strategies

Expert is an accomplished business process and management consultant with a track record and recognition as an ace in his field. A change agent with expertise and experience in LEAN business transformation and change management, Expert has 20 years' experience…

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