Medical Device
Resume:
Michelle Patrice Law, PhD
Email: *******@*****.***
I am residing in California as of 06/01/2014
My training includes:
. Applied microbiological and immunological assay development, design,
validation,
. cGLP, cGMP, Quality Assurance and Compliance.
. 'gap' and risk assessments as part of enhancing and strengthening the
corporate Quality
. Compliance programs with specific focus on Microbiological Safety
. design and execution of studies to assess the validity of the newly
developed assays within the established laboratory methods
. assay troubleshooting and microbiological method development of consumer
products (sterile and non-sterile),
. Phase I-III pharmaceuticals (Rx and OTC) studies, NDA, BLA, MAA
submission writing and the interpretation and translation of US FDA
regulations and practices related to both pre-and post-market activities
for Class I-III medical devices.
. Experience in FDA Human Tissues, and Cellular and Tissue-Based Products
(21 CFR part 1271)
. Reviewing, writing and validating testing and environmental monitoring
protocols according to regulatory guidances and applicable international
standards.
. assessment of manufacturing environments for their suitability to
produce quality regulated products (especially from a microbiological
safety position)
. preparation for ISO and FDA audits as well as the CAPAs needed to
address any observations
. Overseeing the execution of those validation activities with the review
of data and the writing of experimental reports.
Specialties:
. Microbiological Safety of Class I-III medical devices, pharmaceuticals,
combination products & consumer products.
. bio burden, sterility and biocompatibility including strong experience
with ISO 1099-3 and FDA guidance G-95),
. cGLP and cGMP,
. Quality Auditing,
. analytical assay development & validation
. FDA pre-market clearances, Post-Market surveillance,
. Risk assessment, Kaizen facilitation, and SOP development.
PROFESSIONAL EXPERIENCE Technical Director, Microbiology-contract
Quest Diagnostics Laboratories
Greater New York City Area
05/20/2013-05/20/2014
I served as the resource (liaison) to physicians, clients and internal
personnel by responding to technical inquiries. Additionally, I oversaw
quality, instrumentation and automation in the microbiology laboratory as
well as provided support to the network laboratories by undertaking reagent
and instrument evaluations. I was also responsible for the validity,
accuracy, analysis of all testing performed in the laboratory by enhancing
current or suggesting new methodologies. I have implemented a process in
the laboratory that has eliminated discrepant results and corrected reports
to clients. I have started a program for positive culture reporting
providing clients with information needed for epidemiological studies. I
determine and develop departmental technical standards and insure strict
adherence to quality control programs.
Further, partnering closely with both the Medical and Laboratory Directors,
I provided technical, medical and operational direction to the business
unit. I assisted in the interpretation of FDA regulations and procedures in
the marketing of medical devices as well as in the writing review of IVD
(Class II) submissions to the FDA.
Microbiologist & Technical Leader
Kimberly-Clark Corporation, Global Medical Device & Consumer Product Safety
Greater Atlanta, Georgia Area
02/28/2011-02/28/2013
I was 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 included; 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. This allowed Kimberly-
Clark to perform screening of products 'in-house' rather than sending them
out to a contract laboratory, resulting in cost savings for each medical
device requiring such testing. As a result of my risk and safety
assessments, the Health Care Division's product development teams were
better positioned to project medical device design in order to minimize any
foreseen risks thereby keeping the marketing deadline on track.
Additionally, I provided 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. I assisted in the translation of FDA
regulations and procedures in the marketing of medical devices,
participated in design control meetings as well as in the writing and
review of Class II & III medical device submissions to the FDA. Further, I
was responsible for 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 &Acting Branch Chief
FDA (Food & Drug Administration)/CDRH Greater Washington, DC Area
03/04/2007-03/02/2011
Responsible for the review of pre-market submissions from the
pharmaceutical & 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)[Class II], and PMA[Class III] and HDE programs for pre-
market approval and clearance using 21
CFR, scientific expertise, ISO and other international standards.
Additionally, my experience includes serving as a consulting scientist to
assess the safety and efficacy of in vitro diagnostic devices; primarily
those indicated for use in the detection of antibodies to or surface
components of microorganisms. My duties also included serving as a
consulting scientist for the Office of Compliance during field action (post
market) inspections when those activities required a SME (subject matter
expert) in the field of microbiology.
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 y 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
Ann Arbor, Michigan
10/04 - 08/06
Research activities included in vitro diagnostic method development using
hematological as well as immunological methods as part of the development
of a diagnostic platform that would detect immunological markers that could
possibly serve as diagnostic indicators for sepsis.
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. Small animal surgeries and post- surgical care and 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)
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-?) on
Breast Cancer Cell Growth.
The California State University at Fullerton
Bachelors of Arts, June 1997
Major: Biology
PUBLICATIONS
. Eosinophil major basic protein (MBP) and tumor necrosis factor alpha (TNF
?) 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 ?) 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
. Bio-burden rationale for non-sterile products, a Kimberly-Clark internal
White Paper. 2012
REFERENCES
Steven R. Camp, VP of Clinical, Regulatory Affairs & Product Safety, KC
Global Sales, Kimberly-Clark
Corporation. 770-***-****; *****.****@***.***
Lynne Radziwill, Director of KCP Regulatory Affairs & Quality Assurance, KC
Innovation, Kimberly- Clark Corporation. 770-***-****;
*****.*********@***.***
Dr. Herbert Lerner, Deputy Clinical Director, Division of Reproductive,
Abdominal and Radiological
Devices (US FDA/CDRH/ODE); 301-***-****. *******.******@***.***.***
Mr. Johnny Mercer, Quality Program Leader, Global Quality Assurance,
Kimberly-Clark Corporation. +1-770-***-****, ******.******@***.***
Ms. Cheryl Sanzare, Director, Global Regulatory Affairs, Kimberly-Clark
Corporation. ******.*******@***.***, 770-***-****
Dr. Shu-Ping Yang, Medical Director, Health Care, Global Clinical Affairs,
Kimberly-Clark Corporation.
+1-770-***-****. ***-****.****@***.***
Dr. Christina Goode, Professor of Biochemistry and Director of the Office
of Health Professions, California State University at Fullerton.
******@*********.***; 657-***-****.
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