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CONSULTING EXPERIENCE
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| Clients Include |
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Sun Biomedical Laboratories, Blackwood, NJ |
MedApps, Scottsdale, AZ |
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Cranial Technologies, Tempe, AZ |
Sensys Medical, Chandler, AZ |
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Sage Products, Cary, IL |
Akorn Pharmaceuticals, Decatur, IL |
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Wyeth Pharmaceuticals, Rouses Point, NY |
Gen-Probe, San Diego, CA |
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Kleen Test Products, Port Washington, WI |
Abbot Laboratories, North Chicago, IL |
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Amicas Medical, Boston, MA |
Wyndgate Technologies, El Dorado Hills, CA |
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Projects
Include |
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- Preparing pre-IDE,
510(k) and de novo submissions,
re-engineering quality system, managing
efforts to correct Warning Letter
deficiencies, ongoing audits and other
projects.
- Prepared 510(k) submissions for Patient
Wellness System and implementing QSR
processes.
- Ongoing audit and process validation
projects.
- Acted as Director of QA and management
representative for pre-production
designer of non-invasive glucose
measurement instrumentation. Prepared
PMAA submission, ISO and MDD/CE
requirements. Re-engineered quality
system. Headed human factors engineering
and design risk management.
- Developed and implemented various
procedures, assessments and protocols
related to process and software
validations.
- Re-engineered validation processes and
serviced as Acting Director of
Validation for medium sized
pharmaceutical manufacturer.
Responsibilities included
personnel/project management, SOPs,
Validation Master Plans, Validation
Protocols (development, execution and
reports) for products, processes,
facilities, equipment, instrumentation,
test methods, laboratory, lyophilization,
packaging, sterilization and
contractors.
- Developed and executed assessments,
SOPs, validation plans, protocols and
reports for an environmental monitoring
information system including 21CFR11
requirements. Performed annual product
evaluations, including evaluations of
manufacturing and laboratory
investigation reports. Conducted
equipment/process equivalency studies.
Performed various manufacturing
equipment qualifications and
validations.
- Developed SOPs, MVPs, protocols and
executing validations for information
systems and computer controlled
automated equipment, systems, utilities
and processes for biologic and blood
diagnostic products. Validation
requirements include 21CFR11.
- Developed operating SOPs, and developed
and executes validation protocols for
PLC controlled automated equipment and
processes and for building/equipment
cleaning and sanitation for OTC
pharmaceuticals.
- Software, information system, process,
equipment and electronic data/signature
validations, including IQ, OQ and PQ,
for diagnostic products.
- Assessments and white papers regarding
compliance to HIPAA and electronic
data/signature regulations.
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