regulatory, quality and compliance of medical devices, microbiologist
Resume:
Michelle Patrice Law, PhD
Email: *******@*****.***
PROFILE
My training includes applied microbiological and immunological assay development , design, validation, Quality Assurance and Compliance.
Additionally, I possess experience with the design and execution of comparability studies to assess the validity of the newly developed assay with the established laboratory methods; assay troubleshooting and microbiological method development (including RMM).
As a Microbiologist and Regulatory Scientist, my expertise includes FDA regulations (21 CFR, guidances, ISO and other international standards, FDA pre-market approval and clearance review for drugs, biologics and medical devices as well as clinical trial study design, evaluation, and training; inspection support; compliance (21 CFR part 11).
Currently, as a Microbiologist and Technical Leader, I am charged with overseeing the microbiological safety of all Kimberly-Clark medical devices and consumer products, worldwide.
My professional goal is to direct a group focused not only on microbiological safety, but quality assurance and compliance of medical devices, and pharmaceutical products. I am committed to robust science, quality and compliance to insure that the best, safest and most effective products are available on the market.
PROFESSIONAL EXPERIENCE Microbiologist & Technical Leader Kimberly-Clark Corporation,
Global Product Safety
02/28/2011-present
I am responsible for providing the technical expertise for the development and maintenance of a comprehensive microbiological safety program for medical devices and consumer products. These activities would include; the writing of and managing the execution of analytical protocols and methods to address potential risks to product safety, ensuring that methods are established and validated, writing of microbiological safety assessments for current as well as new and innovative products, providing expertise and input for the development of novel products that would involve a microbiological component, trouble shooting and assessing product complaints directly related to
contamination and other microbiological safety issues, writing and publishing position papers related to KC’s position on specific aspects of microbiological safety as it relates to medical devices and consumer products auditing contract laboratories for compliance to cGLP and providing regulatory support where needed to assist in ‘go to market’ timelines.
Microbiologist & Regulatory Scientist Food and Drug Administration
Center for Devices and Radiological Health Office of Device Evaluation Gastroenterology and Renal Devices
Branch
03/04/2007-03/02/2011
Responsible for the review of pre-market submissions from the medical device industry to determine the safety
(sterility, biocompatibility and anti-microbial) of medical devices for approval and clearance.
Review applications to conduct investigation clinical studies of unapproved medical devices under the IDE program,
510 (k), PMA and HDE programs for pre-market approval and clearance using 21 CFR, scientific expertise, ISO and other international standards.
Review and initiate petitions for the reclassification of devices based on 21 CFR, guidances and historical precedence. Interact (face to face, teleconference and submissions) with and provide support to industry and advisory panels which make recommendation on FDA actions regarding selected devices, and conduct continuing reviews, surveillance, and medical device labeling and clinical experience.
POST DOCTORAL RESEARCH FELLOW
The University of Michigan, Ann Arbor Department of Pathology
10/04 – 08/06
* Small animal surgeries and post-surgical care as part of an ongoing investigation into the immunopathology of sepsis.
Research protocols include hematological as well as immunological methods. Research responsibilities have included microbiological and immunological assay development and optimization with validation.
These assays include but are not limited to protein chemistry methodologies (electrophoresis, ion exchange, affinity and size exclusion chromatography, western blotting, GC Mass Spectroscopy and MALDI TOF), ELISA performance and development, protein microarrays, molecular biological techniques (northern, southern, southwestern blotting, gel shift assays, DNA sequencing, PCR and RT PCR), tissue culture, cell separation techniques and flow cytometry. Protein microarrays to assess cytokine levels in septic mice, hematology and chemistry methods were developed and used to assess multiple organ damage as a result of sepsis. Designed and developed an ELISA assay for cystatin C.
* Laboratory required strict adherence to c GLP regulations
* Collect, organize and analyze large data sets using basic computer techniques and statistical software
* Exercised independent judgment for interpretation of data to be discussed with principal investigator
* Write reports on experimental findings
* Prepare posters, presentations and write abstracts (see Publications and Posters)
IMMUNOCHEMIST/MICROBIOLOGIST
Nichol's Institute Reference Laboratories
12/90 - 06/96
* Performed microbiological and immunological studies on samples collected from patients suffering from auto- immune diseases. Performed microbiological and immunological studies on samples collected from patients suffering from auto-immune diseases. Such assays included; anti-cardiolipin, anti-double and single stranded DNA, protein electrophoresis, anti-hepatitis Bantibodies, anti-HIV antibodies, protein C & S, special coagulation.
Additionally, comparability studies were designed and conducted to assess the validity of the newly developed assay with the established laboratory methods; assay troubleshooting which included investigations of out of range results, questionable data and/ discrepancies with established QC standards / CAPAs(routine raw material and product testing, disinfectant/sanitation qualification, water and microbiological “awareness training” of production operators, etc.) and rapid microbiological methods (RMM) development(experience in viability based cellular component (artifact) based, and nucleic acid based technologies; training; inspection support; compliance (21 CFR part 11
* Responsible for quality control and supply * Wrote standard operating procedures
RESEARCH ASSOCIATE
SmithKline Bioscience Laboratories
01/86 - 01/90
* Performed microbiological and toxicology assays. Such assays included; aerobic and anaerobic microbiological culture set up, mycology culture set up, staining and identification of bacteria, Kirby Bauer testing and biochemical characterization of bacteria.
* Responsible for customer service regarding patient sample status
* Sample processing supervisor
EDUCATION
HOWARD UNIVERSITY, WASHINGTON, DC Doctor of Philosophy, December 2004
Major: Microbiology
Title of Dissertation: Characterization and Effects of an Eosinophilic Granular Protein and selected cytokines (IL 4, IL 10, IL 12 and TNF-α) on Breast Cancer Cell Growth. The California State University at Fullerton
Bachelors of Arts, June 1997
Major: Biology
AWARDS AND HONORS
* ASQC-American Society for Quality Control Award for Outstanding MBRS student researcher,
05/97
* MARC-Minority Access to Research Careers travel award, 08/97
* Microbiology Teaching Award 8/2001 - 5/2003
* GAANN-Graduate Assistance in Areas of National Need fellowship, 09/99-08/01
* National Science Foundation Graduate Minority Travel Award, 10/03
PROFESSIONAL ASSOCIATIONS
* American Society for Microbiology (ASM)
* Sigma Xi
American Society of Quality (ASQ)
PUBLICATIONS
• Eosinophil major basic protein (MBP) and tumor necrosis factor alpha (TNF α) inhibit prostate Multi- cellular spheroid (MTS) growth. Proc Amer Assoc Cancer Res, Vol 47, 2006
• Characterization and Effects of an Eosinophilic Granular Protein and Selected Cytokines (IL-4, IL-10, IL-
12, and TNF α) on Breast Cancer Cell Growth. Journal of Interferon & Cytokine Research 26:63-70, 2006
• Hemoconcentration and Increased cytokine profiles in non-resuscitated sepsis. SHOCK, Vol 23, 2005
• Deadly Diseases and Epidemics: Breast Cancer ISBN 078********** Chelsea House Publishers, U.S 15
Sept 2006
REFERENCES
Dr. Herbert Lerner, Deputy Clinical Director, Division of Reproductive, Abdominal and RadiologicalDevices (US FDA/CDRH/ODE); 301-***-****. *******.******@***.***.***
Dr. Christina Goode, Professor of Biochemistry and Director of the Office of Health Professions, California State University at Fullerton. ******@*********.***; 657-***-****.
Dr. Jeffrey C. White, Director, Global Product Safety, Kimberly-Clark Corporation. *******.*.*****@***.***
920-721-252
Ms. Cheryl Sanzare, Director, Global Regulatory Affairs, Kimberly-Clark Corporation. ******.*******@***.***, 770-***-****
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