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Process Automation: Process Control, Computer System Validation, Alarm Management, & Modeling
Expert served for several years as a major pharmaceutical company's chief Quality Assurance GMP/GLP computer validation auditor. He chaired the team that developed the company's first policy and guidelines regarding computer validation,- and served for several years as the company's…
Process Engineering; Project Management-PRINCE2; Process Excellence; Pharma Solid Dosage scale-up
My diverse background includes: . 16+ years of executive management experience with Pharmaceutical and Consumer goods companies such as, Abbott, Pfizer Inc. Bristol-Myers Squibb, Johnson & Johnson, and Procter & Gamble. • Over 10 years experience in Pharmaceutical Development, Engineering…
Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert’s primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet equipment. His experience encompasses all aspects…
Value Added Packaging for Consumer Products
In designing a new consumer product he employs market driven engineering. In essence, the target demographic group is identified and the technologies favored by this group are employed in the customer interface design process, and, more particularly, the technologies abhorred…
Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support,…
Adhesives for Medical Device, Biotech, Pharmaceuticals, Aerospace, Materials Science, QA, QC
With a PhD in organic chemistry expert has spent over 25 years developing adhesives, resins and advanced composites for a variety of applications. He started at the bench chemist level and worked his way up into R&D management. Some of…
Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Oil & Gas/LNG/Chemical Project Development & Management; Engineering & Construction
Expert F. Expert has applied professional chemical engineering knowledge, skills, and experience in evaluating, developing, and selecting alternative chemical process technologies, and has contributed to process improvements developed from existing technologies. Recent technical work involved devising an economical method to…
Medical Packaging: Project Management, Design, Validation, Equipment
Expert is a certified packaging professional with over 20 years experience providing packaging engineering services to the biotechnology and medical device industries. These services include package and labeling development, packaging equipment selection and validation, and package materials and systems performance…
Safety Management in Industry and Construction
At Abbott Laboratories (Ireland) Expert A. Expert served as the chief technical resource for the sterilization of medical devices by ionizing radiation (gamma) and ethylene oxide (EO). He was directly responsible for certification and validation of a number of gamma…