Expert Details
Pharmaceutical Technology, Scale-up, Wet granulation end-point, Tableting, Compaction
ID: 728011
New Jersey, USA
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
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 |
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| 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 |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2000 to 2002 | Agency: FDA presentations | Role: | Description: |
International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2010 to 2010 | Country / Region: Zydus - Cadila, Ahmedabad, India | Summary: 2-day seminar on granulation and tableting |
| Years: 2007 to 2007 | Country / Region: Zentiva, Prague, Czech Republic | Summary: Seminar on wet granulation |
Career Accomplishments
| Associations / Societies |
|---|
| American Association of Pharmaceutical Scientists |
| Professional Appointments |
|---|
| Editor, Pharmaceutical Process Scale-Up |
| 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. |
Additional Experience
| Training / Seminars |
|---|
| He has conducted numerous training courses and seminars, including FDA-sponsored events. |
| Vendor Selection |
|---|
| He has 25+ years of experience of dealing with vendors and suppliers almost daily. |
| Marketing Experience |
|---|
| His list of publications shows a practical understanding of pharmaceutical industry needs and trends. |
| Other Relevant Experience |
|---|
| He is an expert in general business management, computer programming, regulatory compliance, validation and 21CFR Part 11 requirements. |
Language Skills
| Language | Proficiency |
|---|---|
| Russian | |
| Hebrew |
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