Expert Details

Pharmaceutical Technology, Scale-up, Wet granulation end-point, Tableting, Compaction

ID: 728011 New Jersey, USA

Expert has 25 years experience in pharmaceutical process scale-up, wet granulation end-point determination, compaction and tableting. He has published many articles on these topics, edited "Pharmaceutical Process Scale-up" handbook, and wrote chapters in the "Encyclopedia of Pharmaceutical Technology" on the subjects of wet granulation and tableting.

Other qualifications include business management, computer programing, validation and regulatory compliance.

Expert worked extensively with instrumentation and process optimization of roller compaction, mixing-granulation and tableting. He participated in many studies that required process analytical technology for process and product optimization, both in pharmaceutical product development, scale-up and production.

He has developed data acquisition systems for instrumented tablet pressesHe has established a reproducible end-point for high-shear granulator Has successfully determined a source of cracks and capping in a high-speed tableting operationHe has trained key researchers in methods of dimensional analysis for scale-up of pharmaceutical processesHe has optimized and supported a roller compaction study utilizing normal stress data on the rolls

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Education

Year	Degree	Subject	Institution
Year: 1980	Degree: Ph. D.	Subject: BioMathematics/BioEngineering	Institution: University of Washington
Year: 1975	Degree: M. Sc.	Subject: Science	Institution: Hebrew University of Jerusalem

Work History

Years	Employer	Title	Department
Years: 1985 to 2010	Employer: MCC	Title: President, CEO	Department:
Responsibilities: He was responsible for day-to-day operations and project amnagement for a company specializing in pharmaceutical instrumentation
Years	Employer	Title	Department
Years: 1982 to 1985	Employer: Warner-Lambert, Sandoz, Merck	Title: Consultant	Department:
Responsibilities: various projects related to technical programming, documentation and tablet press instrumentation

Career Accomplishments

Associations / Societies
American Association of Pharmaceutical Scientists

Publications and Patents Summary
He has over 20 publications, 3 patents, and has edited two editions of a noted handbook on pharmaceutical process scale-up.

Fields of Expertise

pharmaceutical engineering, pharmaceutical technology, tableting, wet granulation, 21 CFR Part 11, abbreviated new drug application, analytical instrumentation, compliance testing, Current Good Manufacturing Practice, European Union's Good Manufacturing Practice, Food and Drug Administration CFR-21 part 175, Food and Drug Administration regulation, Food and Drug Administration validation, Good Laboratory Practice, Good Manufacturing Practice, process validation, instrumentation engineering, pharmaceutical research and development, pharmaceutical scale-up, roll compacting, pharmaceutical product development, tablet manufacturing, pharmaceutical product formulation, solid pharmaceutical product, pharmaceutical quality assurance, tablet, manufacturing documentation system, drug development, pharmaceutical industry, European standard, scale-up, new product development, drug dosage form development, medical device process validation, engineering management, pharmaceutical manufacturing