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Expert in Validation of Sterilization Processes and USP/AAMI Microbiology, Cleanroom Practices, Aseptics, etc.
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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Expert has years of experience in validating EO sterilization systems per ISO 11135, Gamma sterilization systems per ISO 11137, and Steam sterilization systems per ISO 11134/17665. This would also include troubleshooting and cycle development issues. He has worked with large and small manufacturers, various product types (devices, instruments, sets & kits, pharmaceuticals, biologics, human tissues, implants, sterile surgical disposables, etc), various sterilizer types, and contract & in-house sterilization. Industries include medical device, pharmaceutical, biologicals, and HCTPs. Many questions may be handled on the phone or with a minimal amount of research. He also has considerable experience in the performance and validation of USP / AAMI microbiology test methods (bioburden, sterility test, LAL gel-clot, biological indicators, B/F, disinfectant testing, etc.). Other area of expertise include cleanroom practices/aseptic techniques, biological monitoring of purified water systems, environmental monitoring practices, and the validation of cleaning/reuse processes for the reuse and resterilization of surgical instruments and instrument sets/kits.
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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: Denver, Colorado;
Colorado Springs, Colorado;
Aurora, Colorado;
Fort Collins, Colorado;
Arvada, Colorado;
Pueblo, Colorado;
Westminster, Colorado;
Boulder, Colorado;
Greeley, Colorado;
and Longmont, Colorado.
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Degree |
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Subject |
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Institution |
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Honors |
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1983
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M. S.
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Microbiology
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South Dakota State University
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Dean's List
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1980
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B. S.
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Microbiology
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SDSU
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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1999 to 2001
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Synthes (Synthes-Stratec) USA
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Corporate
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Sterility Assurance Specialist
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Responsible for all sterilization programs, validation, and activities (gamma, EO, steam, Sterrad) for one of the largest device & instrument manufacturers (permanent surgical implants, instruments, and sets) in the US. Pivotal in establishing sterilization requirements for new product development/introductions. Also in charge of environmental monitoring, monitoring of purified water systems, cleanroom monitoring, testing for bioburden, LAL-endotoxin, biological indicators, etc.
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1998 to 1999
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Bayer Pharmaceutical
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Allergy Products (Parenteral & Injectables)
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Microbiology QA Supervisor
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1995 to 1998
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Baxter Healthcare
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Surgical Products Division(s)
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Sterilization Engineer / Senior Microbiologist
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1992 to 1994
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ProCyte Corp
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Therapeutics
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Senior Associate
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1986 to 1992
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ZymoGenetics
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Division of NovoNordisk
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Research Associate III
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1982 to 1986
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Becton Dickinson
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Labware
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QA/Sterilization Microbiologist
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Associations/Societies
AAMI, ASM
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| Selected Consulting Examples: |
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Numerous clients in medical device and HCTP industries. EO, steam, Sterrad, gamma, and various microbiology validation projects.
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Recent Client Requests:
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Expert for consulting on Validation of sterilization according to ISO 11137.
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Expert in Gamma and Ethylene Oxide Sterilization.
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Expert in steam sterilization and Har and soft goods.
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Expert in sterilization for consulting on gamma radiation method issues.
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Steam sterilization expert for consulting on Steam Sterilization of Endoscope.
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Sterilization expert autoclave for consulting on Re-useable Medical Device.
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Expert in Sterilization and validation for surgical instruments for consulting on New Type Hemostat US Pat # 6012363.
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Expert in ETO and gamma sterilization for consulting on training of the applicability of ISO guidelines and AAMI requirements.
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Expert in microbiology/bacteriology for consulting on setting bioburden limits on the incoming animal tissue.
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Expert in 510 k Submission for Medical Product
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Sterility expert for consulting on sterilization of a surgical procedure kit, composed of multiple materials and a sealed pharmaceutical (lyophilized) vial.
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Expert for consulting on EO sterilization and microbiology needed for Class III medical device.
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Expert sterilization etho for consulting on ETO Sterilization.
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Sterilization expert for consulting on sterilization opinion/justification letter.
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Expert in medical devices for consulting on sterile technique.
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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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FDA and medical device expert for consulting on a medical malpractice case.
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Expert in surgical drains for consulting on insufflation of air into wound.
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Expert in FDA litigation for consulting on microbiological contamination of pharmaceuticals.
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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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Training/Seminars
Extensive professional training in QA/QC, Scale-Up, GLP, Validation, and Sterilization.
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Education
