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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…
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…
Digital Transformation: Risk and Engineering
Working with global and international clients and organizations to address emerging, evolving and rapidly changing enterprise risk, governance, risk and compliance, operational risk and resilience, business continuity, crisis management, organizational and digital transformation, as well as control system testing, review,…
Screen Printing, Flexographic, Gravure and Heat Transfer Industries
Career Summary - Expert brings her 30+ years of experience with a multi-faceted background in screen printing, flexographic, UV, gravure and heat transfer industries to the expert witness and consulting world. She has been a successful ink and coating formulator,…
Rubber Compounder and Tool Designer
Expert in: Elastomer development and processing. Expert works for a management team that has over 100 years of combined rubber experience. Expert is committed to long-term partnerships with associates, customers and community. President of a rubber company since 2004, Expert…
Silicone Process Chemistry
Expert has a strong background in experimentation, mechanism reaction kinetics, chemical synthesis, experience with silicon/silicone materials, computational chemistry/engineering, and material characterization. Expert has been inventor and project leader for multiple projects that results in +$1MM/yr in cost savings. Previous roles…
Education
I was a CIO and COO for Tracfone Wireless for over 10 years. I ran IT, development, support, operations as well as call centers, operations, disaster recovery, lead in efficiencies in all operations areas. I bring a lot to the…
Systems Engineer & Mechanical Engineer
Expert is a proud Systems Engineer, Mechanical Engineer, and research associate with over 15 years of experience performing ground breaking research, analyzing business operations, and supporting business solutions. His aim is to utilize his research, engineering, project management, IT proficiency,…
Polymer (Plastics, Composites, Fibers, Nanotechnology) Engineering & Science, Including Formulation, Processing, Characterization, Structure-Property Relationship, Nonwovens, and Coatings
As a professional engineer and scientist, in addition to holding BS (2001), MS (2004), and Ph.D. (2016) in polymer (plastics, composites, & fibers) engineering & science, he has more than 17 years of work experiences in the relevant fields at…
Equipment Validation
Experienced pharmaceutical process engineer with demonstrated ability in managing, supporting, and formulating in a dynamic environment. EQUIPMENT EXPERIENCE Ackley Imprinter Glatt - GPCG-1, GPCG Pro-5, VG Pro 65, Midi Glatt, VG-25, Glatt SKS-100 valves. Korsch - XL400WIP,…