Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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Expert Details

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

ID: 722341 New Jersey, USA

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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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.


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.

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

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.

Education

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

Work History

Years Employer Title Department
Years: 1998 to Present Employer: Undisclosed Title: President Department:
Responsibilities:
Expert is the principal consultant.
Years Employer Title Department
Years: 1979 to 1998 Employer: Astra Pharmaceutical USA Title: Validation/Analyltical Lab Manager Department: Quality Assurance
Responsibilities:
He managed all facility, equipment, and process validation activities. He also managed the QC analytical laboratory.
Years Employer Title Department
Years: 1976 to 1979 Employer: Norwich Pharmacal Title: Quality Control Manager Department: Eaton Laboratories
Responsibilities:
Expert managed the QC function at a solid dosage and API plant in Puerto Rico.
Years Employer Title Department
Years: 1971 to 1976 Employer: Norwich Pharmacal Title: Quality Control Supervisor Department:
Responsibilities:
He supervised the product release group and conducted problem investigations.

International Experience

Years Country / Region Summary
Years: 2005 to 2006 Country / Region: Sweden Summary: 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.
Years: 2002 to 2002 Country / Region: Sweden Summary: He is advising a client on the validation of a new facility for the manufacture of lyophilized products.
Years: 1999 to 2001 Country / Region: Netherlands Summary: Expert advised a client on an aseptic facility design and validation for the manufacture of large volume parenterals for the U.S. market.
Years: 1998 to Present Country / Region: Italy Summary: 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.
Years: 2001 to Present Country / Region: Switzerland, Ticino Canton Summary: Expert works with several clients in the Ticino Canton of Switzerland primarily in the manufacture and control of Sterile products.

Career Accomplishments

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

Additional Experience

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.
Vendor Selection
He has assisted in the selection of primary container closure systems, sterilizing filters, and manufacturing equipment.
Other Relevant Experience
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.

Language Skills

Language Proficiency
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.

Fields of Expertise

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