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 Expert  728011

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


Available for your Consulting and Expert Witness Needs

New Jersey (NJ)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

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.

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pharmaceutical engineering

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pharmaceutical technology

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tableting

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wet granulation

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21 CFR Part 11

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abbreviated new drug application

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analytical instrumentation

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compliance testing

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Current Good Manufacturing Practice

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European Union's Good Manufacturing Practice

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Food and Drug Administration CFR-21 part 175

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Food and Drug Administration regulation

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Food and Drug Administration validation

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Good Laboratory Practice

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Good Manufacturing Practice

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process validation

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instrumentation engineering

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pharmaceutical research and development

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pharmaceutical scale-up

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roll compacting


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York;  Yonkers, New York;  Newark, New Jersey;  Jersey City, New Jersey;  Paterson, New Jersey;  Elizabeth, New Jersey;  Bridgeport, Connecticut;  New Haven, Connecticut;  Stamford, Connecticut;  and Philadelphia, Pennsylvania.

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

Work History:
Years   Employer   Title   Responsibilities

1985 to 2010

 

MCC

 

President, CEO

 

He was responsible for day-to-day operations and project amnagement for a company specializing in pharmaceutical instrumentation

1982 to 1985

 

Warner-Lambert, Sandoz, Merck

 

Consultant

 

various projects related to technical programming, documentation and tablet press instrumentation


Career Accomplishments:
Associations/Societies

American Association of Pharmaceutical Scientists

Professional Appointments

Editor, Pharmaceutical Process Scale-Up


Publications:
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.

Selected Publications and Publishers  
 - Informa Healthcare, London  
 - Encyclopedia of Pharmaceutical Technology  
 - Encyclopedia of Pharmaceutical Technology. Marcel Dekker  
 - Drug Development and Industrial Pharmacy  
 - International Journal of Pharmaceutics  

Government Experience:
Years   Agency  
2000 to 2002   FDA presentations  

Consulting Services:
Selected Consulting Examples:
  • He has developed data acquisition systems for instrumented tablet presses
  • He has established a reproducible end-point for high-shear granulator
  • Has successfully determined a source of cracks and capping in a high-speed tableting operation
  • He has trained key researchers in methods of dimensional analysis for scale-up of pharmaceutical processes
  • He has optimized and supported a roller compaction study utilizing normal stress data on the rolls
Recent Client Requests:
  • Expert for consulting on Wet granulation.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Wet granulation formulation and tableting expert for consulting on pharmacetuical patent infringement case.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2010 to 2010   Zydus - Cadila, Ahmedabad, India   2-day seminar on granulation and tableting
2007 to 2007   Zentiva, Prague, Czech Republic   Seminar on wet granulation

Language Skills:
Foreign Language  
Russian  
Hebrew  

Market Research:
His list of publications shows a practical understanding of pharmaceutical industry needs and trends.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

He has conducted numerous training courses and seminars, including FDA-sponsored events.

Supplier and Vendor Location and Selection

He has 25+ years of experience of dealing with vendors and suppliers almost daily.

Other Skills and Services

He is an expert in general business management, computer programming, regulatory compliance, validation and 21CFR Part 11 requirements.


 

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