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Expert in GMPs for Drugs, Devices, Biologics
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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The primary focus of Expert's career has been to establish documentation systems that support the quality assurance requirements of GMP and ISO regulations for product development and commercial manufacturing. This experience has allowed her to provide system design and training in nonmedical companies as well.
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Expert has knowledge of regulations, both the "letter of the law" and their implied requirements. She is familiar with drug, device, diagnostic, and biologic product regulations and how to interpret these requirements in practical day-to-day procedures.
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Her knowledge of the regulations regarding bulk chemical, biologic, and pharmaceutical manufacturing is of primary importance to Expert in her consulting work. She focuses not only on helping companies decipher what to do, but she also can provide practical guidance on how to fulfill the expectations of GMP and GLP regulations.
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Validation establishes the quality of utility systems, equipment, analytical methods, software and product processing. Expert assists in the design and creation of validation protocol documents for drug, device, diagnostic, and biologic manufacturers.
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Knowledge of the processes for industrial scale processing of medical products is fundamental to the medical manufacturing environment. Expert has worked directly with the validation of dry heat sterilizers, steam sterilizers, filter sterilization, and SIP systems. She has also gained experience with ETO and radiation sterilization systems, cleaning validation, process validation, and method validation.
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Expert is familiar with the United States and European Community guidelines which reference ISO requirements for medical devices and medicinal products. Her focus has been on how GMPs will support ISO requirements instead of creating side-by-side, independent systems for quality assurance.
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Process design, process control, and process validation are a primary focus of FDA inspection and, as a result, a primary focus of Expert's current work.
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Expert routinely presents 1-3 day training seminars on GMPs, custom designed to the intended audiences.
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In the area of pharmaceutical product development and manufacturing operations, Expert has performed educational audits of development, production, testing, and distribution facilities for drug, device, diagnostic, and biologic operations. These audits can be used as a prelude to a formal training presentation for staff or as a means to assess and propose solutions to quality systems issues.
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Expert helps companies design quality management systems for the development or manufacture of medical products that meet the design control regulations of 21 CFR 820.30 or EN 46001 and the GMP requirements of 21 CFR 211, 606, 820. These systems facilitate design control, validation, change management (unexpected and planned change), and documentation.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Duluth, Minnesota.
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Degree |
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Subject |
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Institution |
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1974
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Graduate studies
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Biochemistry/Genetics
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University of Minnesota
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1971
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BA
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Biology
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Lawrence University
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1971
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Certification
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Electron Microscopy
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Boston
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Employer |
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Title |
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1986 to
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Independent Consultant
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1980 to 1986
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Smith Laboratories, Inc .
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Director of Quality Control
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1978 to 1980
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Envirodyne Engineers
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Laboratory Supervisor for EPA project & Asst. to V.P.
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1978 to 1978
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Loyola University
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Research Associate
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1976 to 1977
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University of Illinois
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Research Associate
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1971 to 1975
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University of Minnesota
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Research Associate
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Associations/Societies
Expert is a member of the Parenteral Drug Association.
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Selected Publications and Publishers
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- Interpharm Press
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- Parexel International Corporation
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- Advanstar Communications
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- (In preparation.)
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- Submitted for publication.
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Recent Client Requests:
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FDA sterile medical device regulatory expert for consulting on sterile package integrity validation.
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Expert in ISO 9000 for biopharmaceuticals for consulting on ISO9000 auditing.
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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.
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Recent Litigation Client Requests:
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Expert in pharmaceutical manufacturing.
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FDA expert in medical devices for consulting on products liability litigation.
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Expert in drug manufacturing safety for consulting on drug manufacturing safety.
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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.
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| Additional Skills and Services: |
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Supplier and Vendor Location and Selection Expert has experience locating vendors in all areas associated with the supplies and equipment needed in the monitoring and controlling of aseptic cleanroom operations in the medical product manufacturing environment. She has access to print materials and personal contacts.
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Other Skills and Services
Expert designs and assists in the implementation of monitoring and control programs for clean rooms and controlled areas in aseptic manufacturing environments. She has experience working with systems designed to provide monitoring and control of bacteria, fungi, yeast, molds, endotoxins, cytotoxins, product residues, and disinfectant residues. Expert also assists small medical companies as they move products from R & D laboratories into full-scale production.
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Education
