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 Expert  722341

Expert in Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation


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 has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the design of planned and unplanned interventions during aseptic processing. Using this procedure, he has been able to modify HVAC and air directional systems to address process simulation (media fill) failures.
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aseptic pharmaceutical process validation

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aseptic packaging process

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airflow visualization

Expert has developed and executed cleaning validation master plans for multi-product parenteral facilities and solid dosage manufacturing facilities. He has recently developed a cleaning validation master plan for a manufacturer of oligonucleotides using solid phase reaction vessels. In the execution of these plans, Expert has aided clients in the development and validation of sampling procedures and analytical methods.
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cleaning validation

Expert routinely conducts cGMP audits and pre-approval inspections at clients' manufacturing facilities and at third party manufacturers. These inspections evaluate all aspects of pharmaceutical manufacturing and control, including quality systems, laboratories, material handling systems, facilities, equipment, and documentation systems. In addition to providing a detailed list of observations, Expert provides suggested remedies to address these observations.
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Current Good Manufacturing Practice

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Good Manufacturing Practice

Expert has provided guidance to clients on the validation of manufacturing processes for numerous types of drug products including liquid parenteral products, lyophilized parenteral products, solid dosage forms, metered-dose inhalers, and sterile suspensions. He has worked directly with filter manufacturers on behalf of clients for the validation of sterile filtration processes of numerous products.
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drug validation

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process validation

Expert routinely conducts cGMP audits and pre-approval inspections at clients' manufacturing facilities and at third-party manufacturers to ensure continued compliance with FDA regulations and the accuracy of information submitted to the FDA as part of an ANDA or NDA. These inspections evaluate all aspects of pharmaceutical manufacturing and control, including quality systems, laboratories, material handling systems, facilities, equipment, and documentation systems. In addition to providing a detailed list of observations, Expert provides suggested remedies to address these observations.
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Food and Drug Administration compliance

Expert has provided guidance to clients on the validation of manufacturing processes for numerous types of drug products including liquid parenteral products, lyophilized parenteral products, solid dosage forms, metered-dose inhalers, and sterile suspensions. This guidance incorporates both "good science" and compliance to the FDA guidance on process validation. He has worked directly with filter manufacturers on behalf of clients for the validation of sterile filtration processes of numerous products.
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Food and Drug Administration validation

Expert uses HACCP in the development of process validation protocols and in conjunction with "root cause analysis" for failure investigation. As a pharmaceutical quality assurance professional for more than 30 years, he has conducted both Out of Specification (OOS) and manufacturing deviation investigation and prepared reports to identify the root cause of failures and prevent their future occurrence. Expert has developed training programs for personnel involved in HACCP and failure analysis and has provided direct training for clients involved in this task.
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hazard analysis critical control point

Expert has provided guidance to clients on the validation of manufacturing processes for numerous types of drug products including tablets, coated tablets, capsules, creams, ointments, and suspensions.
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nonaseptic pharmaceutical process validation

Expert has assisted in the design of pharmaceutical manufacturing facilities and processing systems for the manufacture of parenteral products. He has also conducted HACCP evaluations of both solid dosage and liquid drug products. He brings both practical production and quality assurance perspectives to the evaluation of drug processing facilities and systems.
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pharmaceutical manufacturing

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drug processing

Expert has designed validation protocols for the validation and continued monitoring of systems used to generate "purified water" including carbon filters, water softeners, reverse osmosis (RO) systems, deionized water (DI) systems, and ultra-filtration systems. He has also designed validation protocols for the validation and continued monitoring of systems used to generate water for injection (WFI) and pure steam. The scale and complexity of these systems has ranged from laboratory scale to large manufacturing plant systems with a multiple effect still, several storage tanks, and multiple recirculating loops.
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pharmaceutical water treatment system validation

Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the design of planned and unplanned interventions during aseptic processing. Using this procedure, he has been able to modify HVAC and air directional systems to address process simulation (media fill) failures.
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aseptic filling

Expert has advised clients in the development, manufacture and control of injectable drugs. Expert has experience with pre-filled syringes, cartridges, vials, ampoules, lyophilized products and aseptically filled powders for injection.
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injectable drug

Expert has developed training programs for inspectors responsible for the 100% inspection of parenteral products for foreign particulate matter.
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inspector training


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;  Newark, New Jersey;  Jersey City, New Jersey;  Elizabeth, New Jersey;  Trenton, New Jersey;  Camden, New Jersey;  Philadelphia, Pennsylvania;  Allentown, Pennsylvania;  Reading, Pennsylvania;  and Wilmington, Delaware.

Often requested
with this expert:

Sterilization; Food & Drug Product, Packaging & Process...
Pharmaceutical Product Development and Good Manufacturing...
Pharmaceutical Technology, Manufacturing, Quality Systems...
HACCP, LACF, Low Acid Aseptic, Process Controls, Process...

Education:
Year   Degree   Subject   Institution  
1986   M.B.A.   Business Administration   Clark University  
1971   M.S.   Organic Chemistry   University of Georgia  
1968   B.S.   Chemistry   Georgia Tech  

Work History:
Years   Employer   Department   Title   Responsibilities

1998 to

 

(Undisclosed Consulting Company)

 


 

President

 

Expert is the principal consultant.

1979 to 1998

 

Astra Pharmaceutical USA

 

Quality Assurance

 

Validation/Analyltical Lab Manager

 

He managed all facility, equipment, and process validation activities. He also managed the QC analytical laboratory.

1976 to 1979

 

Norwich Pharmacal

 

Eaton Laboratories

 

Quality Control Manager

 

Expert managed the QC function at a solid dosage and API plant in Puerto Rico.

1971 to 1976

 

Norwich Pharmacal

 


 

Quality Control Supervisor

 

He supervised the product release group and conducted problem investigations.


Career Accomplishments:
Associations/Societies

Expert is a member of PDA, ISPE, ACS, ASQ, and IEST.


Publications:
Publications and Patents Summary

He has contributed two chapters to books on process validation and environmental monitoring and has made presentations to industry groups on topics ranging from cleaning validation to aseptic processing.

Selected Publications and Publishers  
 - Environmental Monitoring, Jeanne Moldenhauer, ed. Davis Harwood International, PDA  
 - Validation of Pharmaceutical Processes, Carleton and Agalloco, eds. Marcel Dekker  

Consulting Services:
Selected Consulting Examples:
  • Expert has developed facility validation master plans and cleaning validation master plans.
  • He has performed HACCP for aseptic processes for both microbial and particulate matter contamination.
  • Expert has managed the technology transfer of several parenteral and solid dosage products between companies and at inter-company sites.
  • He has developed a cleaning validation master plan for equipment used to synthesize and purify oligonucleotides.
  • Expert managed the validation startup of numerous automated filling lines for the manufacture of parenteral products.
Recent Client Requests:
  • Expert in aseptic manufacturing for consulting on clean room commisioning.
  • Usp validation expert.
  • Expert in FDA compliance for consulting on adherence to aseptic process findings.
  • Water quality expert deionized for consulting on DI Water System Survey.
  • Haccp juice expert for consulting on Juice Haccp plan.
  • GMP expert in bulk chemical manufacturing for consulting on the development of a new cGMP Bulk manufacturing facility.
  • 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.
  • Expert for consulting on Airflow issues in Aseptic room.
  • Expert for consulting on Need a HACCP plan in PLace.
  • Expert in cosmetic packaging engineer for consulting on skin care packaging design and development.
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:
  • Drug formulation expert for consulting on Amifostine.
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
2005 to 2006   Sweden   Expert assisted a major pharmaceutical manufacturer in the risk analysis of their aseptic process for the manufacture of pre-filled syringes and the development of risk based Environmental Monitoring program.
2002 to 2002   Sweden   He is advising a client on the validation of a new facility for the manufacture of lyophilized products.
1999 to 2001   Netherlands   Expert advised a client on an aseptic facility design and validation for the manufacture of large volume parenterals for the U.S. market.
1998 to   Italy   Expert has worked with numerous clients in Italy on a variety of projects ranging from aseptically manufactured parenteral products to solid oral dosage forms. Expert spends on average 8 wks per year in Italy.
2001 to   Switzerland, Ticino Canton   Expert works with several clients in the Ticino Canton of Switzerland primarily in the manufacture and control of Sterile products.

Language Skills:
Foreign Language   Description
Spanish   Expert is able to understand most conversational Spanish and speaks a little. He can read most Spanish technical documents.
Italian   He is able to understand most conversational Italian and speaks a little. He can read most Italian technical documents.

Additional Skills and Services:
Training/Seminars

Expert developed a training course for process validation concepts and critical process parameters and made presentations concerning cleaning validation, change control, and airflow visualization.

Supplier and Vendor Location and Selection

He has assisted in the selection of primary container closure systems, sterilizing filters, and manufacturing equipment.

Other Skills and Services

Expert is recognized as one of the leading experts in the remediation of cleanrooms and the design of aseptic procedures through the use of airflow visualization studies.


 

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