“the age of auditing” february 2015 1 incorporating usda and aaalac requirements into your...

“The Age of Auditing” February 2015

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Incorporating USDA And AAALAC Requirements Into

Your Overall Inspectional Practices

Jordan Publico, B.S., RLATG, ILAM, RQAP-GLPSenior Quality Assurance Auditor

Charles River, Insourcing Solutions (CRIS)


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Presentation Objectives

• USDA mission and regulations

• USDA audit goals

• AAALAC mission and guidelines

• AAALAC accreditation program

• AAALAC inspection process

• Are you to be reviewed?


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USDA

• The U.S. Congress passed the Animal Welfare Act (AWA) in 1966.

• United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) enforce this Act to ensure the well–being of animals used in laboratory research.

USDA regulating documents• The AWA covers nearly all species of warm blooded

animals used in research

• An amendment to the AWA in 2002 excluded birds, mice of the genus Mus, and rats of the genus Rattus bred for use in research

• The AWA does not regulate animals used in elementary or secondary education, or farm animals used in agricultural research, food, or fiber.


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USDA Regulating Documents

• Title 21 Food and Drug Act of the Code of Federal Regulations (CFR)

• Part 58 of Title 21, Good Laboratory Practices (GLP)


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USDA Audit Goals

Review research facilities using regulated animals.

• Non-human primate facilities

• Facilities housing dogs

• Large animal non-agricultural facilities


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USDA Audit Goals

• To ensure that research facilities provide their animals with proper veterinary care

• To ensure that a veterinary program outlines procedures such as the administration of vaccines, regular examinations, and the care of sick animals

• To ensure provisions for humane euthanasia is provided in accordance with the American Veterinary Medical Association (AVMA 2007)


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USDA Audit Goals

• Review the facilities Institutional Animal Care and Use Committee (IACUC)

• Ensure AWA compliance, and utilize the 3 R’s (Replace, Reduce, Refine)

• Ensure that staff have adequate training and education


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AAALAC

• Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) was in incepted in 1965

• Promotes humane treatment of laboratory animals through a voluntary accreditation program called a Program Status Evaluation (PSE)

• The PSE is a confidential peer review that helps assess the quality of all aspects of your animal research program


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Why seek AAALAC Accreditation?

AAALAC Accreditation Ensures:• Quality and Commitment to Animal Care Excellence• Scientific Validity• Public Accountability• Global Market Harmonization• Recruiting Tool

Note: Any public health service funded research facility is required to seek and maintain AAALAC accreditation.


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AAALAC guidelines

• The ‘Guide for the Care and Use of Laboratory Animals’ (National Academy of Sciences 2011)

• Reference resources are used for specifics that ‘The Guide’ does not address such as; Biosafety, Health Monitoring, Euthanasia, Occupational Health, and Education


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AAALAC Inspection Process

• A Senior Director of AAALAC is identified as inspection team lead

• Inspection starts with an in-briefing meeting

• Facility walk-through is conducted

• Meetings scheduled with care and research staff, representatives from oversight committees, and the Institutional Official


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AAALAC Inspection Process• Review of IACUC Policies and SOP’s• Assessment of Physical Plant• Review of Lab Animal Management

Micro and Macro Environment

- Space Recommendations - Ventilation

- IlluminationBehavioral ManagementStructural and Social EnvironmentTreatment and surgical records


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AAALAC Inspection Process

• On-site inspection ends with an out-brief meeting.

• Review team will convene with the AAALAC council to accept and/or reject inspection findings, and makes the final decision on accreditation.

• The final report should be received in 6 – 10 weeks post inspection with areas for corrective action if required.


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Corrective Action

• Mandatory Item = deficiency which must be corrected for Full Accreditation to be awarded or continued

• Suggestion for Improvement (SFI) = item which the Council feels is desirable to upgrade an already acceptable or even commendable program

Receiving Accreditation

• Initial and full approval is good for three years

• Provisional approval is good for one year


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Are you ready to be reviewed?

• Inspect physical plant and cleanliness

• Inspect ALL animal support areas and supplies

• Review ALL animal and veterinary records and supplies

• Check ALL support equipment for current certifications/calibration


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Quality is doing the right thing the first time when no one is looking!

References:• www.fda.gov• www.usda.gov• www.aaalac.org• www.sqa.org• www.aalas.org

Contact information:Jordan Publico, B.S., RLATG, ILAM, [email protected] National Capital Area Regional Chapter Society of Quality Assurance NCARSQA President 2015, Past President 2016. SQA AHSS

mailto:[email protected]

Society of Quality Assurance (SQA)


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- SQA is an association of over 2,200 QA professionals who are dedicated to implementing industry, governments, academia requirements, information sharing, and consulting.

• Good Clinical Practices (GCPs) • Good Laboratory Practices (GLPs) • Good Manufacturing Practices (GMPs)

SQA Chapters


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National Capital Area Regional Society of Quality Assurance (NCARSQA)

1• Education Programs.

2• Dexter Goldman Memorial Scholarship Award eligibility.

3• NCARSQA Educational Scholarship Award eligibility.

4• Leadership Training and Networking Opportunities.

5• Newsletters.

6• Company profiles and job postings advertised on website and newsletters.

7• NEW BRAND! NEW WEBSITE!

COMING SPRING 2015!

www.NCARSQA.org


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• AALAS is an association of professionals that advances responsible laboratory animal care and use to benefit people and animals.

• AALAS provides educational materials to laboratory animal care professionals and researchers, administers certification programs for laboratory animal technicians and managers, publishes scholarly journals, supports laboratory animal science research, and serves as the premier forum for the exchange of information and expertise in the care and use of laboratory animals.


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American Association for Laboratory Animal Science (AALAS)

AALAS Districts

• 1: Northern Mountain• 2: Central PA.• 3: National Capital Area Branch (NCAB)• 4: Appalachian• 5: Central OH.• 6: Central IL.• 7: Mile-High• 8: Western Mountain


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philosophy.com

The headlines you make

in this life will be based on

the difference you made

in the lives of others.


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“the age of auditing” february 2015 1 incorporating usda and aaalac requirements into your...

Documents

age of auditing

animal research program

laboratory research

education slide

aaalac guidelines

aaalac association

aaalac requirements

care of sick animals