Training Quality Assurance

Deborah A. Wenger

ADDRESS

Consultant

Training and Regulatory Compliance

*** ********* *****

Downingtown, PA 19335

610-***-**** - Office

484-***-**** - Mobile

**********@*******.***

EDUCATION

May 1982 BS Delaware Valley College of Science and

Agriculture, Doylestown, PA.

Major: Animal Science

Minor: Laboratory Animal Science

PROFESSIONAL EXPERIENCE

August 2001- PRESENT: Deborah Wenger Training and Regulatory

Compliance Consulting

NEW BOLTON CENTER, UNIVERSITY OF PENNSYLVANIA, KENNETT SQUARE, PA:

PENNSYLVANIA ANIMAL DIAGNOSTIC LABORATORY SYSTEM

QUALITY ASSURANCE MANAGER, NOVEMBER 2007 - MAY 2011

VANDERBILT UNIVERSITY, NASHVILLE, TN: DIVISION OF ANIMAL CARE: MAY

2007 - PRESENT

-- DEVELOPMENT OF ANIMAL CARE STANDARD OPERATING PROCEDURES

-- EVALUATION AND RECOMMENDATION OF ANIMAL CARE WORK FLOW PROCESSES

NORTH WESTERN UNIVERSITY: JANUARY 2006 - DECEMBER 2006

-- DEVELOPMENT OF GLP ANIMAL CARE STANDARD OPERATING PROCEDURES

TWIN VALLEY SCHOOL DISTRICT: SUBSTITUTE TEACHER, APRIL 2003 - PRESENT

BLUE CROSS BLUE SHIELD OF DELAWARE: WILMINGTON, DE. ENROLLMENT

SERVICES: SEPT 1, 2005 - DEC 31, 2005

-- DEVELOPMENT OF WORKFLOW PROCESSES

-- DEVELOPMENT OF STANDARD OPERATING PROCEDURES

PRUDENTIAL FINANCIAL, EASTERN OPERATIONS, DRESHER, PA: MAY 2004 - DEC

31 2005

-- DEVELOPMENT OF INTEREST SENSITIVE CALCULATION TRAINING PROGRAMS FOR

OVERSEAS TRAINING INITIATIVE.

-- DEVELOPMENT OF WEB BASED TRAINING APPLICATION FOR NEW BUSINESS ON-

LINE SYSTEM

ASTRAZENECA PHARMACEUTICALS, WILMINGTON, DELAWARE: AUGUST 2001 - APRIL

2004

-- DEVELOPMENT, IMPLEMENTATION AND PROJECT MANAGEMENT OF AN ANIMAL

USER WEB BASED TRAINING APPLICATION

-- DEVELOPMENT OF GLP ANIMAL CARE STANDARD OPERATING PROCEDURES

-- DEVELOPMENT OF GLP VETERINARY MEDICINE CLINICAL STANDARD OPERATING

PROCEDURES

JULY 1991- AUGUST 2001: MERCK RESEARCH LABORATORIES, LABORATORY

ANIMAL RESOURCES: WEST POINT, PA.

POSITION: TRAINING SUPERVISOR

Duties: Guided the development and training of all animal care and research

personnel involved with the use of animals. This included, developing,

identifying, scheduling and conducting training programs in compliance with

all

government regulations and guidelines.

Deborah A. Wenger Page II

Managed a comprehensive SOP Program to include:

-- Development of GLP compliant and non GLP Animal Care SOPs

-- Guidance in the development of Veterinary Care SOPs

-- Participation in QA inspections and assistance in responding to

questions and/or issues of compliancy

-- Working with and guiding front line Supervisors to ensure compliance

with applicable regulations

-- Maintenance of documents to comply with Company and regulated Record

Retention Policies

-- Organizing training for all animal care personnel

-- Coordinating the activities of an SOP Committee for purpose of

reviewing, updating and developing SOPs

Provided regulatory support to the Institutional Animal Care and Use

Committee Coordinator in the regulatory review process of Animal Research

Protocols.

Assisted the LAR Diagnostic Laboratory performing the following functions;

Sentinel Program Bleeding, Environmental Water Testing, ELISA Testing, and

Microbiology Inventory Control

Significant Contributions:

-- Development/Implementation of a CD-ROM computer based multi-media

training application for Animal Users.

-- Development of specie specific multi-media computer based training

applications for Animal

Care Personnel.

-- Development/Implementation of a written competency based training

program for Animal Care Personnel

working in Safety Assessment and Basic Research Facilities.

-- Administration of the AALAS Certification Training Program.

-- Established a working relationship with the Collective Bargaining Unit

to ensure

-- Organized a comprehensive SOP Management Program to ensure that SOPs are

consistent with regulations and

policy standards.

-- Development/Implementation of a Departmental Employee Recognition

Program for Salaried and Collective

Bargaining Unit Employees.

October 1988 - July 1991: Merck Research Laboratories, Laboratory

Animal Resources, West Point, PA.

Position: Supervisor, Safety Assessment Animal Facility (58,000

sq. ft)

Duties: In compliance with departmental Standard Operating

procedures, MRL study requirements, as well as

all applicable regulations and guidelines, directly supervised 45-50

Animal Care Personnel coordinating all

activities related to direct and indirect animal care.

Additional responsibilities included training, motivation and safety

of reporting personnel; assuring proper

operation and maintenance of the animal facility; interacting with

research investigators to provide MRL

study support; and providing input with the purchasing of all

animals, equipment and supplies as required by the department

Significant Contributions:

-- Development/Implementation of a training program for a new

Specific Pathogen Free (SPF) Animal Facility

for over 300 Research and Animal Care personnel. This included

an instructional package and videotape

for future training of new personnel.

-- Organized the sanitation and occupation of the new SPF Safety

Assessment Facility.

-- Development of manpower efficiency standards, which maximized the

utilization of available labor pool.

June 1988 - October 1988: Wyeth-Ayerst Laboratories, Inc. Clinical

Communications, Radnor, PA.

Position: Clinical Project Administrator

Duties: Coordinated various group activities for Investigational

Drug Projects in order to meet scheduled

deadlines for New Drug Submissions to the FDA.

Deborah A. Wenger Page III

November 1987- June 1988: Wyeth-Ayerst Laboratories, Inc: Clinical

Data, Radnor, PA.

Position: Clinical Data Assistant

Duties: Maintained data related to cardiovascular clinical

studies.

January 1986-November 1987: Wyeth-Ayerst Laboratories, Inc. Animal

Health Services, Radnor, PA.

Position: Supervisor, Animal Care Diagnostic Laboratory

Duties: -- Managed the operation of the Animal Health Diagnostic

Laboratory, the Animal Health Surveillance

Program and the Germ Free Housing Programs.

-- Maintained all facility records in accordance with

government regulations.

-- Assisted in developing and maintaining Facility Standard

Operating Procedures.

-- Established work assignments and aided in the selection of

animal care personnel.

-- Performed and coordinated special project assignments and

experimental studies as directed by the

Veterinary Manager and/or Research Investigator.

October 1983- January 1986: Wyeth-Ayerst Laboratories, Inc. Animal

Health Services, Radnor, PA.

Position: Laboratory Animal Technician, Group Leader

Duties: Animal Care and Maintenance of the following species:

Primates, Dogs, Cats, Mice, Rats,

Guinea Pigs, Rabbits, Ferrets, Pigs, Goats and

Ducks. Other duties included; Blood collection,

Diagnostic testing (Hematology, Parasitology,

Urinalysis), Tissue collection, Necropsy evaluations, surgical

pre-operative preparation of acute research

animals, and Administration of medication.

March 1983- October 1983:Wistar Research Institute, Animal Facility,

Philadelphia, PA.

Position: Animal Care Technician

Duties: Animal care and maintenance of rodent colonies under

germ free conditions.

PROFESSIONAL ORGANIZATIONS

American Society for Quality: 2008-present

American Association of Veterinary Laboratory Diagnosticians: 2008 -

present

Delaware Valley Branch of the American Association of Laboratory Animal

Science

2008-2009: Program Chairperson

2004-2005: AALAS TriBranch Symposium Committee: AREA Program Chair

2001-2002: President

AALAS TriBranch Symposium Committee: AREA Program Chair

2000-2001: President -Elect

AALAS TriBranch Symposium Committee: Autotutorials Chair

AALAS TriBranch Symposium Committee: AREA Program Chair

1999-2000: President

AALAS TriBranch Symposium Committee: Autotutorials Chair

1998-1999: President - Elect

AALAS TriBranch Symposium Committee: Publicity

Chairperson

1997-1998: AALAS TriBranch Symposium Committee: Workshop Co-

Chairperson

1996-1997: Education Chairperson

Laboratory Animal Science & Technology Seminar

Chairperson

1995-1996: Education Chairperson

Laboratory Animal Science & Technology Seminar Co-Chairperson

AALAS TriBranch Symposium Poster Judge

1995-1996: AALAS TriBranch Symposium Committee-Workshop Chairperson

1987-1993: Secretary

1989-1993: Technicians Affair/COLAT Chairperson

1986-1987: Program Committee Co-Chairperson

1985-1986: Awards Committee

Deborah A. Wenger Page IV

National American Association of Laboratory Animal Science: 1987 - present

Laboratory Animal Welfare Training and Exchange (LAWTE)

2005 - LAWTE Conference Committee: Registration Chair

2001-2003 - LAWTE President

2001 - LAWTE Conference Committee: Program Chair

Center for Arts and Technology

(Pickering Campus Small Animal Care Advisory Committee, Phoenixville,

Coatesville, PA)

ACADEMIC AND PROFESSIONAL HONORS

2007 National Association of Professional & Executive Woman Registry

"Women Of Excellence"

March 2003 Emergency Teaching Certification Permit

July 2002 Instructional System Designer Certification

Sept. 1996 DVB-AALAS Dr. Henry Schneider Award

May 1995 Institute for Laboratory Animal Management Graduate

January 1984 AALAS-Assistant Laboratory Animal Technician

June 1984 AALAS-Laboratory Animal Technician

OTHER ACCOMPLISHMENTS

Mid- Atlantic Region Society of Quality Assurance GLP Fundamental Workshop

- November 2003

PSBR Essay Contest Judge (1998 - 2005)

Twin Valley School District, Robeson Elementary Science Fair Judge (2000 -

2006)

Religious School Instructor - Grade 4 (1999 - 2005)

AALAS Animal Research Education Awareness Program - National Meeting, 1999,

2000, 2002, 2003, 2004

PUBLICATIONS AND PRESENTATIONS

Singleton, W., Clifford, P., Wenger, D, "Increase Staff Productivity and

Efficiency and Improve Customer Service." Presented at the National Meeting

of the American Association for Laboratory Animal Science, Charlotte, NC.

2007.

Moreau, N. Wenger, D., "Writing Standard Operating Procedures that Work."

Presented at the National Meeting of the American Association for

Laboratory Animal Science, Charlotte, NC. 2007.

Wenger, D., Fritz, L., " How To Design An Effective Training Program."

Presented at the National Meeting of the American Association for

Laboratory Animal Science, Salt Lake City, Utah. 2006

Wenger, D., Moreau, N., "SOP, Policy, and Procedure Writing." Presented at

the Laboratory Animal Welfare Training Exchange Conference, San Diego,

CA.2005

Wenger, D., Fritz, L., " How To Design An Effective Training Program."

Presented at the National Meeting of the American Association for

Laboratory Animal Science, Tampa, FL. 2004

Wenger, D., Feldstein, M., Munro, T., Shockey, J., Rosenzweig, D.,

Peterman, L., "An Innovative Approach to Developing and Delivering

Multimedia Web-Based Training for Laboratory Animal Care." Presented at the

National Meeting of the American Association for Laboratory Animal Science,

San Diego, Ca. 2000.

Wenger, D., Sturchio, C., Ingham, K., Shockey, J., Cancelleri, S., Orsini,

C., Peterman, L., Bauser, A., Klein, H., Anderson, L., "Developing a

Multimedia Training Program for Laboratory Animal Care." Presented at the

National Meeting of the American Association for Laboratory Animal Science,

Indianapolis, IN. 1999.

Deborah A. Wenger Page IV

Wenger, D., Sturchio, C., Ingham, K., Shockey, J., Cancelleri, S., Orsini,

C., Peterman, L., Bauser, A., Klein, H., Anderson, L., Developing a

Multimedia Training Program for Laboratory Animal Care., Contemporary

Topics In Laboratory Animal Science. July 1999; 38; 4; p32.

Wenger, D., Klein, H., "Committees-Their Role and Interactions in the

Research Environment." Presented at the National Meeting of the American

Association for Laboratory Animal Science, Pittsburgh, PA. 1994.

Wenger, D., Klein, H., Hughes, F., Conboy, T., Lauman, M., Semler, G.,

Curtis, B., Meyers, R., Pulli, M., Wiesenberger, K., "The Development of a

Comprehensive Training Program for Laboratory Animal Resource Personnel."

Presented at the National Meeting of the American Association for

Laboratory Animal Science, Anaheim, Ca. 1992.

Wenger, D., Conboy, T., Klein, H., Garelik, J., Terpeluk, W., Pouch, W.,

Hayden, C., Jackson, R. "The Development of a Comprehensive Training

Program for a Transition from a Conventional Rodent Colony to a Specific

Pathogen-Free Colony in a New Toxicology Testing Facility." Presented at

the National Meeting of the American Association for Laboratory Animal

Science, Milwaukee, WI. 1990.

REFERENCES AVAILABLE UPON REQUEST

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