Debra Howeth has over 10 years of experience as a Biosafety Specialist at the University of South Florida where she oversees all activities related to the Institutional Biosafety Committee including reviewing protocols, conducting inspections, and providing training. She has over 25 years of experience in laboratory settings performing various techniques such as PCR, DNA sequencing, and ELISA. Howeth received her Masters in Public Health from the University of South Florida and is a member of several professional organizations related to biosafety and microbiology.
Sample Tracker: A web-based application for tracking and managing environment...Gerard Devine
Poster presented at eResearch Australasia 2014 in Melbourne on the Sample Tracker application developed and operating at the Hawkesbury Institute for the Environment
Improving surveillance and early detection of Foot-and-mouth And Similar Tran...EuFMD
ANSES assessment of laboratory needs and capacities.
Improving surveillance and early detection of Foot-and-mouth And Similar Transboundary (FAST) animal diseases in the South-East European Neighbourhood (SEEN) countries / ANSES assessment of laboratory needs and capacities.
Virtual Workshop.
27-30 April 2020.
Kas bendro tarp laimės, vergijos ir reklamos? Popietės pranešimo metu apie tai, kaip išsivaduoti iš darbo vergijos pasakojo Darius Radkevičius, knygų „Dievas. Kvantinė fizika. Organizacijos struktūra. Vadovavimo stilius“ ir "Belaukiant Aukso Amžiaus" autorius
Sample Tracker: A web-based application for tracking and managing environment...Gerard Devine
Poster presented at eResearch Australasia 2014 in Melbourne on the Sample Tracker application developed and operating at the Hawkesbury Institute for the Environment
Improving surveillance and early detection of Foot-and-mouth And Similar Tran...EuFMD
ANSES assessment of laboratory needs and capacities.
Improving surveillance and early detection of Foot-and-mouth And Similar Transboundary (FAST) animal diseases in the South-East European Neighbourhood (SEEN) countries / ANSES assessment of laboratory needs and capacities.
Virtual Workshop.
27-30 April 2020.
Kas bendro tarp laimės, vergijos ir reklamos? Popietės pranešimo metu apie tai, kaip išsivaduoti iš darbo vergijos pasakojo Darius Radkevičius, knygų „Dievas. Kvantinė fizika. Organizacijos struktūra. Vadovavimo stilius“ ir "Belaukiant Aukso Amžiaus" autorius
It s a presentation that I presented to my colleagues at work ( dialysis center - levant hospital ) to show the importance of this dialysis mode applicated in our center...
waiting for ur comments
Position Summary:
Responsible for developing, implementing and managing systems to mitigate the risk of experiencing unacceptable levels of bioburden in products. This includes establishing best practices, process controls and environmental monitoring programs that reduce the potential for microbial product contamination. Also responsible for training manufacturing associates on aseptic technique and monitoring and coaching production associates at their work stations.
Key Responsibilities:
•Microbial sampling, identification & bioburden mapping of production facilities.
•Bioburden challenge studies for existing and new product formulations.
•Bioburden risk assessment and validation for new product development process.
•Aseptic process development and process control.
•Environmental and water monitoring of Rockford and Wisconsin sites.
•Interpret test results and initiate corrective actions as needed.
•Assist with equipment and process cleaning validations.
•Clean room management inclusive of mentoring and supervising 23 clean room associates.
•Microbial test-method development as per USP test method suitability.
•Contamination investigations & implementation of corrective actions.
•Prepare reports and present data with conclusions.
•Maintain microbiology laboratory equipment and supplies.
Also efficiently performed Preservative Efficacy Challenge Tests, Environmental monitoring, LAL Endotoxin testing (Kinetic & Gel Clot methods), Microbial Ingress Integrity Testing (both Dye Penetration & Bacterial Challenge testing), Microbial Identification using Biolog, Mycoplasma testing of products using Luminometer, Bioburden & Water testing.
1. Debra Howeth
7433 Moffitt Florida
Land O Lakes, Florida 34638
(813) 842-7020
dxwoman@gmail.com
Professional Experience:
Biosafety Specialist, 2010 to Present
University of South Florida- Tampa, Florida
Compliance and assurance activities related to the Institutional Biosafety program
Oversee and manage all activities related to the Institutional Biosafety Committee (IBC)
This includes receiving and processing applications, pre-reviewing applications for
completeness, facilitating the protocol review process for 12 IBC members, creating the
monthly meeting agenda and minutes, and managing our electronic database. Our
program includes 214 active PIs; over 350 active protocols; and approximately 100
annual submissions. In addition, due to our affiliation with the Moffitt Cancer Center, we
have over 35 human gene transfer studies at our institution
Conduct and oversee our lab and facility site inspection program to ensure compliance
with standard containment practices per the CDC’s standard Biosafety in Microbiological
and Biomedical Laboratories (BMBL) 5th Edition. About 60 site inspections are
completed on an annual basis
Develop and provide training to new IBC Committee members, researchers, lab staff,
students Principal investigators and clinical protocol coordinators. For example, annual
Biosafety training, Biosafety training for individual university courses. Provide in-person
training for over 600 personnel on an annual basis
As Assistant Responsible Official for our Select Agent (SA) program, I assist in the
oversight of compliance with the Federal regulations. This includes maintenance of all
records related to the SA program, providing training, inspecting the registered lab
spaces, corresponding with the PI and research staff, ensuring that all requirements are
fulfilled annually. Conduct annual exercise/drill of SA plans and revises plans as
necessary
Work closely with both the Institutional Animal Care and Use Committee (IACUC) and
the Institutional Review Board by reviewing initial protocols and amendments for any
Biosafety related items that would require oversight by the IBC
Develop internal laboratory standards, procedures, and practices to ensure compliance
with state and federal regulations and industry best practices. This includes our
University’s biosafety manual, spill response, and occupational exposure response
Serve as a liaison to our Occupational Health program and the Environmental Health and
Safety department. This includes sitting on the University’s Laboratory and Field Safety
committee. As a part of this committee, I provide guidance on biosafety related issues
Serve as a member on the James A Haley Veteran's Hospital Subcommittee for Research
Safety. In this position, I ensure that projects at the VA by USF researchers comply with
the University’s IBC policies
Assist investigations of incidents related to biological exposures/releases and potential
non-compliance reports/events
Serves on two external IBCs as a community member
2. Associate in Research, 2003-2010
Center for Biological Defense, University of South Florida, Tampa, Florida
Performed laboratory duties such as PFGE, Riboprinting, Antimicrobial testing (E-test
and Sensititre), Real-time PCR (ABI and Roche Lightcycler), traditional PCR, Southern
blotting, DNA extraction, DNA Sequencing, reagent preparation, scientific writing
Ordered lab Supplies
Maintained aspects of laboratory management
Worked in the Bio Safety Level 3 laboratory
Worked with Select Agents
Assistant in Research, 2001-2003
Center for Biological Defense, University of South Florida, Tampa, Florida
Performed laboratory duties such as PFGE, riboprinting, antimicrobial testing, Real-time
PCR, reagent preparation, scientific writing
Senior Laboratory Technician, 1998-2001
H. Lee Moffitt, University of South Florida, Tampa, Florida
Performed laboratory duties such as tissue culture; 2-D gel electrophoresis; western
blotting, immunohistochemistry; protein extractions; reagent preparation
Ordered lab Supplies
Program Secretary, 1997- 1998
Science Advising Center, University of South Florida, Tampa, Florida
Scheduled appointments
Answered phone
Assisted students with questions
Collected and distributed mail
Laboratory Technician, 1994- 1997
Department of Chemistry, University of South Florida, Tampa, Florida
Performed laboratory duties such as Antibody screening of a cDNA library; protein
purification by column chromatography; enzyme assays; SDS-page gel electrophoresis;
western blotting; DNA PCR and agarose gels; growth and maintenance of bacterial
cultures; restriction enzyme digests, ligation, and transformation; preparation of reagents
Ordered lab Supplies
Laboratory Technician, 1991-1993
James A Haley Veteran’s Hospital, University of South Florida, Tampa, Florida
Performed laboratory duties such as monoclonal antibody fusion and screening; tissue
culture; creating and optimizing an ELISA for ouabain; performance of RIA and ELISA
for various steroids; preparation of reagents
3. Education
Masters of Public Health (M.P.H.) in Tropical Public Health/Communicable Diseases
University of South Florida, Tampa, FL
Bachelors of Science (B.S.) in Microbiology
University of South Florida, Tampa, FL
Professional Memberships
Member of the Southeastern Biological Safety Association
Past member of Florida Public Health Association
Past member of The American Society for Microbiology