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 Expert  108149

Expert in Pharmaceutical Process Validation & FDA Compliance


Available for your Consulting and Expert Witness Needs

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

Summary of Expertise: Listed with other top experts in: 
Expert is an expert in industrial pharmacy and pharmaceutical process validation. He understands the technology of transferring laboratory pharmaceutical formulations into successful pilot production processes, and high volume production processes.
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pharmaceutical manufacturing

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nonaseptic pharmaceutical process validation

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pharmaceutical drug

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pharmaceutical product formulation

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pharmaceutical technology

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pharmaceutics

Expert uses statistical process controls in the analysis of pharmaceutical production processes. He has studied statistical techniques for predicting the shelf life stability of pharmaceuticals. He also knows techniques for calculating thermal sterilization conditions for injectable products based on process parametrics.
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pharmaceutical quality assurance

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pharmaceutical quality control

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pharmaceutical product shelf life testing

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statistical process control

Expert has knowledge of the pharmaceutical aspects of dermatologicals and cosmetics (skin treatment and hair care), over the counter drugs, and nutritional supplements.
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cosmetic product

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cosmetic product development

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cosmetic product formulation

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skin care product

Expert is a consultant to the FDA on validation & GMP matters. He is considered to be a leading expert on Pharmaceutical Process Validation, having authored the first paper on the subject. In addition to solid dosage form technology, he has written extensively on sterile products, pharmaceutical suspensions, drug stability and cosmetic systems.
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Current Good Manufacturing Practice

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drug validation

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Food and Drug Administration validation

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pharmaceutical engineering

Expert is familiar with new techniques for drug delivery such as transdermal delivery, intranasal application, liposomal systems, as well as microencapsulation techniques.
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drug delivery


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;  Hartford, Connecticut;  and Philadelphia, Pennsylvania.

Often requested
with this expert:

FDA Compliance, Pharmaceutical New Products, Management...
Pharmaceutical Technology, Manufacturing, Quality Systems...
Pharmaceutical Product Development and Good Manufacturing...
FDA Regulatory Consultant for Medical Devices, Cosmetics,...

Education:
Year   Degree   Subject   Institution  
1958   Ph.D.   Pharmaceutics   University of Connecticut  
1954   M.S.   Pharmaceutical Chemistry   Rutgers University  
1952   B.S.   Pharmacy   Long Island University  

Work History:
Years   Employer   Department   Title   Responsibilities

1981 to 1999

 

St. John's University

 


 

Associate Professor

 


1976 to 1981

 

Purdue Frederick Co.

 


 

Director of Pharmaceutical Development

 


1960 to 1976

 

Lederle Laboratories Division of American Cyanamid Co.

 


 

Manager of Pharmaceutical R & D

 


1957 to 1960

 

Merck Sharp and Dohme Research Laboratories

 


 

Research Associate

 


2002 to

 

(Undisclosed)

 

Pharmaceutical Engineering

 

Adjunct Professor

 

Expert is responsible for the Validation & Regulatory Affairs course.

2002 to

 

(Undisclosed)

 

Mechanical Engineering

 

Adjunct Professor

 

He conducts primary teaching in the new Pharmaceutical Engineering program.


Career Accomplishments:
Associations/Societies

Expert is a member of the Institute of Validation Technology, International Society of Pharmaceutical Engineers, the Academy of Pharmaceutical Sciences, the American Chemical Society, and the American Association of Pharmaceutical Scientists.

Professional Appointments

Expert is a member of the editorial advisory board of "Journal of Validation Technology."


Publications:
Publications and Patents Summary

Expert has published widely in the fields of Pharmaceutical and Cosmetic Science and holds nine U.S. patents.

Selected Publications and Publishers  
 - Marcel Dekker, Inc  
 - Skin Pharmacology  
 - Drug Development and Industrial Pharmacy  
 - Journal of Parenteral Science and Technology, Parenteral Drug Association  

Government Experience:
Description
Expert consults to the FDA on validation and cGMP matters.

Consulting Services:
Recent Client Requests:
  • FDA expert to provide training regarding GMP and nw regulations.
  • FDA expert for consultation to provide pre approval and post approval support to ensure approval of a NADA with a minimum of time spent in the review cycle of T-Pro.
  • Quality control expert in statisical process control in new york area for consulting on Implement SPC to quality control.
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:
Expert Witness Experience Summary:
Expert has been an expert witness in pharmaceutical patent cases.
Recent Litigation Client Requests:
  • Expert for consulting on product liability action
  • Dietician expert for consulting on manufacturer's nutritional supplement claims.
  • Expert for consulting on breach of contract case
  • FDA expert witness for consulting on an atypical antipsychotic..
  • FDA expert witness for consulting on medical malpractice case involving the legality of prescribing Biotropin and Tev-Tropin.
  • FDA regulations and/or scientific research standards expert for consulting on litigation against pharmaceutical company from wrongful termination of employee.
  • Expert in current good manufacturing practice for consulting on GMP.
  • Expert for consulting on Trade Secret Litigation - Nutritional Supplement Industry.
  • FDA regulatory expert for consulting on OTC skin lightening cream product liability 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.

Additional Skills and Services:
Training/Seminars

He conducts seminars and workshops on process validation for both sterile and non-sterile pharmaceutical processes.

Supplier and Vendor Location and Selection

Expert has experience locating vendors of bulk pharmaceutical drugs, key excipients, packaging materials and laboratory scale pharmaceutical and cosmetic equipment.

He can help provide vendor information through printed materials and contacts.


 

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