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 Expert  722537

Expert in Statistics and Data Management; Pharmaceutical Industry


Available for your Consulting and Expert Witness Needs

Florida (FL)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

Expert has vast experience in the field of pharmaceutical development. He has been responsible for managing all quality laboratories, and product quality assessment and release to market. He has also evaluated process and product data for 54 drug products and prepared reports for the U.S. FDA. He has developed sampling plans in support of a program to assess the outcome of a clinical trial for a drug.
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drug development

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chemical process control

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drug formulation

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drug product approval

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drug regulation

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Food and Drug Administration compliance

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Food and Drug Administration regulation

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clinical data management


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Miami, Florida;  Hialeah, Florida;  Fort Lauderdale, Florida;  Hollywood, Florida;  Pembroke Pines, Florida;  Port Saint Lucie, Florida;  Miami Beach, Florida;  West Palm Beach, Florida;  Pompano Beach, Florida;  and Boca Raton, Florida.

Education:
Year   Degree   Subject   Institution  
1968   PhD   Chemistry   University of Delaware  
1962   BA   Chemistry   C.C.N.Y.  

Work History:
Years   Employer   Department   Title   Responsibilities

2001 to

 

(Undisclosed)

 


 

President

 

Consult primarily for the pharmaceutical industry

1996 to 1998

 

SoloPak Pharmaceuticals Inc.

 

SoloPak Laboratories

 

V.P. Quality,Regulatory & Scientific Affairs

 

He is responsible for all technical and scientific affairs, regulatory matters, and product quality program.

1994 to 1996

 

Biocraft Laboratories Inc.

 


 

Director of Quality

 

He is responsible for managing all quality laboratories, and product quality assessment and release to market.

1983 to 1994

 

Huls America Inc.

 


 

V.P. R&D

 

He is responsible for product and process development and support.

1979 to 1983

 

Air Products and Chemicals Inc.

 

Houdry Division

 

Technical Director

 

He is responsible for product and process development and support.

1968 to 1979

 

E.I. duPont de Nemours and Company

 

Dyes, Chemicals and Pigments department

 

Research Manger

 

He is responsible for product and process development, and technical support.


Career Accomplishments:
Associations/Societies

AAPS; DIA; ISPE; ASQ; ASA


Publications:
Publications and Patents Summary

He has six publications.


Consulting Services:
Selected Consulting Examples:
  • Evaluated process and product data for 54 drug products and prepared reports for the U.S. FDA.
  • Evaluated product and process data for a new drug substance in support of a Drug Master File.
  • Developed sampling plans in support of a program to assess the outcome of a clinical trial for a drug.
  • Conducted an inspection of manufacturing process equipment and process and product data for problem resolution.
  • Evaluated and assessed historical process and product data to identify control, drift and change.
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:
  • Expert for consulting on pharmaceutical statistics for litigation.
  • FDA expert witness generic drug for consulting on Litigation in Federal Court.
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
1998 to 1999   Japan / Asia   He supported the develoopment of a Drug Master file for a new drug substance: product and process data. analysis.
2000 to 2000   South Korea / Asia   He supported the development of a Drug Master file for a new drug substance: product and process data.
2000 to 2000   South Korea / Asia   He supported the development of a Drug Master file for gelatin capsule process control for drug manufacture.
2001 to 2002   Israel / Asia   He supported the development of a New Drug Application with product and process evaluation.

Additional Skills and Services:
Training/Seminars

Quality Control in the Pharmaceutical Laboratory; Quality Control Statistics; Statistics for Drug Stability


 

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