Expert Consulting and Expert Witness Services

  home    |    expert directory    |    using intota    |    about us    |    blog    |    contact us    |    request an expert     expert login & enrollment  
  
  search tips 
Share this page:  Send to LinkedIn Send to Facebook Tweet This Email Print

 Expert  721932

Expert in OTC Drugs, Generic Drugs, New Drugs and General Drug Regulations and FDA Requirements


Available for your Consulting and Expert Witness Needs

Virginia (VA)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
During his tenure with FDA since 1991, Expert served in the Policy and Guidance Branch of the Center for Drug Evaluation and Research (CDER) with responsibility for the development and interpretation of the Current Good Manufacturing Practice Regulations for Pharmaceuticals and the development of compliance policy guides, inspection guides and guidelines regarding pharmaceutical manufacturing.
 • 

Current Good Manufacturing Practice

Most recently with the FDA he served as the official liaison between CDER and the United States Pharmacopeial Convention, Inc. (USPC). There he was responsible for the management and assessment of all USPC compendial revisions on approved and pending drug applications; the certification of all insulin products marketed in the U.S.; and the evaluation of stability data for shelf life extension studies conducted for the Department of Defense.
 • 

drug regulation

 • 

Food and Drug Administration new drug code

 • 

Food and Drug Administration regulation

Expert worked for the FDA for 30 years. He began as a pharmacist with the U.S. Public Health Service and served at several hospitals and medical clinics throughout the country. In 1981 he was assigned to the headquarters office in Rockville, Maryland and served in a variety of pharmacies and health resource and service oriented positions.
 • 

Food and Drug Administration


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Baltimore, Maryland;  Frederick, Maryland;  Gaithersburg, Maryland;  Bowie, Maryland;  Richmond, Virginia;  Alexandria, Virginia;  Wilmington, Delaware;  and Lancaster, Pennsylvania.

Often requested
with this expert:

OTC, Generic, and New Drugs, Medical Device Regulations
Pharmaceutical Consulting
Pharmaceutical Product Development and Good Manufacturing...
FDA Litigation, Regulatory Compliance and Strategy & FDA...

Education:
Year   Degree   Subject   Institution  
1975   M.P.H.   Health Services Administration and Planning   University of Hawaii, School of Public Health  
1965   P.D. and B.S.   Pharmacy   University of Maryland, School of Pharmacy  

Work History:
Years   Employer   Department   Title   Responsibilities

1995 to

 

Expert's Firm

 


 

Senior Consultant

 

Expert advices clients on matters of OTC drugs, generic drugs, new drugs, and FDA regulations.

1993 to 1995

 

Center for Drug Evaluation and Research

 

Compendial Operations Branch

 

Chief

 

He was the official liaison between the U.S. Pharmacopeial Convention, Inc. and Center for Drug Evaluation and Research.

1991 to 1993

 

Center for Drug Evaluation and Research

 

Policy and Guidance Branch, Division of Manufacturing

 

Director, Health Promotion Officer, Consumer Safety Officer

 

His primary responsibility was the development of agency policy regarding pharmaceutical manufacturing compliance, reviews of foreign firms, and communication with the bilateral countries.

1989 to 1991

 

HRSA - Office of Health Facilities

 

Division of Facilities Loans

 

Director

 

Expert administered the loan facility monitoring responsibilities to all health facilities with direct and guaranteed Hill-Burton loans and Department of Housing and Urban Development mortgage insurance for hospitals. He supervised a staff of 23 professionals and support personnel in the central office and had operational responsibility for personnel in the ten regional offices.

1986 to 1989

 

HRSA - Bureau of Resources Development

 

Division of Facilities Assistance and Recovery

 

Director

 

Expert directed a national program to assure the provision of federal assistance for medical services to eligible beneficiaries under Title VI-VIII and XVI of the PHS Act. With a staff of 18 professionals, he actively monitored 5,900 facilities with grants amounting to $4.7 billion.

1985 to 1986

 

HRSA - Bureau of Health Maintenance Organizations and Resources Development

 

Division of Facilities Resources

 

Deputy Director

 

He shared responsibility for the direction of the Division's programs and 20 personnel. The Division had responsibility for the analyses and collection of an information base on the health care industry.


1983 to 1985

 

HRSA - Bureau of Health Care Delivery and Assistance

 

Division of Primary Care Services

 

Chief, Pharmacy Officer

 

Expert developed bureau-wide programs and policies. He was responsible for the implementation of pharmacy, as well as other clinical programs, within the Division to assure the organized delivery of health care services at the over 600 community and migrant health care managed facilities by the Division.


1982 to 1983

 

HRSA - Bureau of Health Care Delivery and Assistance

 

Division of Beneficiary Medical Programs

 

Associate Director for Operations

 

He was responsible for the administration of a nationwide medical care program for approximately 46,000 eligible beneficiaries, employing a staff of 28 with an annual operating budget of over $20 million dollars.



Career Accomplishments:
Associations/Societies

Expert is a member of the Maryland Pharmaceutical Association, the American Society of Health Systems Pharmacists, the Association of Military Surgeons of the United States, the Commissioned Officers Association of the United States Public Health Service (USPHS), and the Federal Health Care Executives Institute Alumni.

Awards/Recognition

Expert has received the following awards: Surgeon General's Exemplary Service Medal (1995); Meritorious Service Medal (1989); Commendation Medal (1983, 1991); Public Health Service Citation (1981, 1987); Outstanding Unit Citation (1985, 1988); Unit Citation (1981, 1982, 1984, 1989); and the Bureau of Medical Services Director's Award (1982).


Publications:
Publications and Patents Summary

Expert has published and presented ten papers at conferences.

Selected Publications and Publishers  
 - Philadelphia Pharmaceutical Forum, AAPS  
 - Society of FDA Pharmacists  
 - American Association of Pharmaceutical Scientists  
 - United States Public Health Service  
 - Chemical Specialties USA Symposium  

Government Experience:
Agency   Role   Description
Food and Drug Administration (FDA)   Various   Expert worked for the FDA in various capacities for 30 years.

Consulting Services:
Recent Client Requests:
  • Otc drug expert for consulting on OTC cold sore med requirements.
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:
  • FDA expert needed for consulting regarding FDA regulation needed for ongoing litigation.
  • Pharmaceutical manufacturing expert to evaluate manufacturing process and CGMP issues related to a pharmaceutical company's production of a double dosage of certain drugs.
  • FDA warning expert testimony for consulting on generic prescription drug warnings; compliance with FDA standards of package insert warning; dear doctor warning letters.
  • FDA expert witness for consulting on an atypical antipsychotic..
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:
Country / Region   Summary
Europe   He has traveled throughout Europe performing cGMP compliance audits.


Additional Skills and Services:
Training/Seminars

He has taught a FDA national training course during an orientation to international inspections titled “Inspection of Bulk Drug Facilities.”


 

Need the right expert?  We can help!

Privacy Policy   ©2014 ORC International - All Rights Reserved.