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Wendi
M. Lindenmuth, BS - Director Quality and Regulatory Affairs
wkazeks@katzanalytical.com
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Education:
Western
Michigan University, Kalamazoo, MI
Qualifications
and Accomplishments:
Developed and implemented Quality Systems
and Programs in compliance with FDA regulations (cGMP,GLP,FTC) from
start-up to established companies.
Experience in general toxicology,neuroscience, orthopedics,surgery,
immunotoxicology, clinical pathology, and bio-analytical and analytical
laboratory functions.
Experienced in writing and assessing protocols and SOP’s to
ensure compliance with FDA GLP and cGMP regulations.
Held senior level Quality and Regulatory positions with medical
device, pharmaceutical,pre-clinical, and dietary supplement companies
for ten years.
Continuing
Development:
Quality System Regulation (QSR) 21 CFR part
820
Medical Device Reporting 21 CFR part 803
FDA 21 CFR part 11 Training
A Practical Approach to Compliance with 21CFR part 11
FDA GLP Training
GCP Training for the Clinical research Coordinator Certificate
Radioactive Materials
NTI Advertising Compliance Course Certificate (FTC regulations)
FDA cGMP Dietary Supplement Training
FDA cGMP GMP Training
Professional
Memberships:
Society of Quality Assurance (SQA) |
Philip J.
O'Keefe, PE, BS - Mechanical Engineer
pokeefe@katzanalytical.com
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Education:
B.S. Engineering, Illinois Institute of Technology,
Chicago, IL
Professional Licenses:
Professional Engineer, State of Minnesota,
License No. 45527
Professional Engineer, State of Illinois, License No. 061-030777
Model Law Engineer, NCEES, Certificate No. 29725
Qualifications
and Accomplishments:
Recipient of US Patent No. 6,623,184 for a
medical diagnostic imaging device. Patent is pending. (Application
No. 20090066486) for an Ethernet-based room occupancy management
system for healthcare facilities.
Improved product design using risk management techniques including
FMEA, Six Sigma DOE, and Kaizen.
Familiar with FDA (cGMP and QSR) regulations and ISO 13485.
Prepared and submitted 510(k) documents to FDA for new product approval.
Designed digital and analog electronics for medical device applications.
Nine years of experience providing expert witness and litigation
support services.
Professional
Memberships:
Minnesota Society of Professional Engineers
National Society of Professional Engineers
Intellectual Property Owners Association
American Bar Association
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