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Good Laboratory Practice (GLP)

This course provides training on good laboratory practice for non-clinical laboratory studies that reflects regulations and best practices established by key regulatory agencies and guidelines.

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About this Course


Good Laboratory Practice (GLP) describes how nonclinical laboratory studies should be planned, performed, monitored, recorded, reported, and archived as set forth by the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA), as well as the Organization for Economic Co-operation and Development (OECD) international guidelines.

It is intended for anyone involved or planning to be involved in nonclinical laboratory studies within industry, academia, government, or other testing facilities. It provides a working knowledge of GLP that supports and reinforces technical education and training.

Individuals who complete the course as an independent learner will receive a professional certificate from the University of Miami's Division of Continuing and International Education (DCIE).

This course was authored by Kathryn Hackett-Fields, RQAP-GLP of QualiStat, Inc. and peer-reviewed by experts.

Disponibilidad del idioma: English

Audiencias sugeridas: Nonclinical Researchers


CE Credits and Units


To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first.

Physicians

AMA PRA Category 1 Credit

7 credits
(14 CE Certified Modules)
$95

1 January 2016
31 December 2019

Psychologists

CE Credit/Hour

7 credits
(14 CE Certified Modules)
$95

1 January 2016
31 December 2019

Nurses

Contact Hour

4 credits
(8 CE Certified Modules)
$70

7 January 2016
7 January 2018

Other Participants

Certificate of Participation

7 credits
(14 CE Certified Modules)
$85

1 January 2016
31 December 2019


Course Content


Toggle Content CITI GLP Course: Overview

Provides a brief overview of the GLP course.

Uso recomendado: Required
ID (Idioma): 16778 (English)

Toggle Content History of the Good Laboratory Practices: A Breach of Trust CME/CEU Badge

Discusses the need for GLP regulations including the historical events that led to their initial development. It identifies how the foundations of GLPs are translated into practical controls, guidelines, and standard procedures encountered by technical and other laboratory/research personnel.

Uso recomendado: Required
ID (Idioma): 16696 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc

Toggle Content Here & There: U.S. and Global Regulatory Agencies CME/CEU Badge

Describes the scope and mission of the FDA, EPA, and OECD concerning nonclinical laboratory studies. It compares the typical types of study groups submitted to the FDA and EPA, and identifies the different methods used by these agencies to inspect a submitted study’s data, testing facility, and personnel for GLP compliance.

Uso recomendado: Required
ID (Idioma): 16697 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content Let’s Be Clear: Words Matter in GLP CME/CEU Badge

Identifies definitions from the FDA, EPA, and OECD GLP regulations. It is intended to help learners master specific GLP terms and differentiate key terms having a similar focus among the regulations.

Uso recomendado: Required
ID (Idioma): 16698 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content Components of Compliance CME/CEU Badge

Explains how the foundations of GLP are observed and expressed in nonclinical laboratory settings, and in FDA’s GLP regulations. It identifies general elements of a quality system, intersecting points between key study documents that establish study control and direction, and how to evaluate and improve SOPs used in a testing facility.

Uso recomendado: Required
ID (Idioma): 16701 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content GLP Requirements of Personnel CME/CEU Badge

Identifies the regulatory requirements and responsibilities for personnel involved in all aspects of regulated studies including staff (technical and non-technical), study directors, management, QA personnel, and PIs.

Uso recomendado: Required
ID (Idioma): 16699 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content The Responsible Use of Laboratory Animals (LA) – Part 1 CME/CEU Badge

Introduces the GLP regulations pertinent to the use of animals in research and testing, as well as their intersection with the Animal Welfare Act. It identifies the appropriate methods of interaction between technicians responsible for nonclinical studies and personnel responsible for tasks related to animal care and vivarium operations.

Uso recomendado: Required
ID (Idioma): 16703 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content The Responsible Use of Laboratory Animals (LA) – Part 2 CME/CEU Badge

Identifies GLP requirements for study conduct and how they affect interactions between technical and animal care personnel. It describes the general process of an Animal and Plant Health Inspection Service (APHIS) inspection, and how to achieve regulatory compliance in end-of-study procedures such as collection of specimens, euthanasia, and necropsy.

Uso recomendado: Required
ID (Idioma): 16704 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content Standard Operating Procedures (SOPs) and Equipment Operation CME/CEU Badge

Identifies the importance that SOPs for common operations and equipment maintenance have on establishing a quality system. It discusses the GLP requirements for SOP preparation and differences in requirements for equipment found in research and testing facilities, and equipment that generates or measures data.

Uso recomendado: Required
ID (Idioma): 16702 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content Understanding Raw Data and Reconstruction CME/CEU Badge

Discusses the importance of raw data collection and analysis in nonclinical laboratory studies. It describes what constitutes raw data, the importance of raw data, how to collect and evaluate raw data, and how reconstruction of study data is accomplished to bridge gaps in a GLP-compliant manner.

Uso recomendado: Required
ID (Idioma): 16700 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content Required Reading: Study Protocols CME/CEU Badge

Describes the importance and role of the protocol in nonclinical laboratory studies. It discusses how the protocol is developed and used by the study director, technicians, QA personnel, and in regulatory enforcement, as well as the reasons for documentation and communication of protocol changes and deviations to all personnel involved in the study.

Uso recomendado: Required
ID (Idioma): 16705 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content Archiving Study Data and Specimens CME/CEU Badge

Presents the GLP requirements for a compliant study archive including the procedures that should be used to protect an archive from common hazards. It identifies the responsibilities of all personnel typically involved in archiving.

Uso recomendado: Required
ID (Idioma): 16708 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content The Quality Assurance Unit (QAU) CME/CEU Badge

Describes the purpose and functions of the QAU. It discusses appropriate interactions with QA professionals during study or husbandry inspections, and the requirement for QA independence from study conduct.

Uso recomendado: Required
ID (Idioma): 16707 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content Chemicals, Test Articles, and Solutions CME/CEU Badge

Identifies GLP requirements for the receipt, distribution, storage, and disposal of chemicals. It describes the role of laboratory personnel in ensuring security and integrity of test and control articles, and other commonly used substances. It also discusses the proper handling procedures for commercial products and test articles by using information provided on material safety data sheets (MSDSs) and SOPs.

Uso recomendado: Required
ID (Idioma): 16706 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

Toggle Content Reporting of Study Results and Regulatory Decisions on Study Disqualification CME/CEU Badge

Discusses the requirements involved in creating a final report of study results intended for submission to the regulatory authorities. It identifies the conditions that may result in the disqualification of a study by FDA or EPA, and describes the role of a compliance statement in a final report. It also shows the ways in which data integrity and overall quality is directly related to the actions of study and supervisory personnel.

Uso recomendado: Required
ID (Idioma): 16709 (English)
Autor (es): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.


FAQs


Toggle ContentWhat is the importance of GLP training?

GLP training ensures that nonclinical laboratory studies are planned, performed, monitored, recorded, reported, and archived as set forth by the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Department of Agriculture (USDA), as well as the Organisation for Economic Co-operation and Development (OECD) international guidelines.

Toggle ContentWhen should someone consider taking the GLP course?

This course is suitable for learners seeking an educational resource that helps ensure compliance with GLP regulations and guidelines. There is no uniform standard for how frequently GLP training should occur. For a retraining (refresher) cycle, organizations should designate the frequency for their learner groups. Unlike other CITI Program courses, there is no “refresher” version available at this time, but learners can retake the GLP course or complete whatever subset of modules their organization has selected for them.

Toggle ContentHow is this course structured?

It consists of 15 modules that provide a highly detailed training on GLP regulations and guidelines. The modules contain expert content, images, supplemental materials (such as, case studies), and a quiz. Learners may complete the modules at their own pace.

Toggle ContentWhat regulations and topics does GLP cover?

GLP discusses FDA, EPA, and USDA regulations, and OECD international guidelines pertaining to GLP. It also covers a history of GLP, U.S. and international regulatory agencies, GLP definitions, compliance with GLP, personnel responsibilities, use of laboratory animals, SOPs and equipment operation, raw data and reconstruction, study protocols, archiving study data and specimens, quality assurance, chemicals and test articles, reporting study results, and study disqualification.

Toggle ContentWhat are the recommendations for setting up a GLP learner group?

CITI Program allows organizations to customize their learner groups, which means they can choose the content modules their learners need to complete. We will work with your CITI Program designated admin to determine the learner groups that best fit your organizational needs.

The standard recommendation for GLP is to designate each module as required in a learner group. This helps to ensure a complete training for the learner. However, organizations may also elect to present certain modules as supplemental, particularly when the organizations provide specific training on the topic(s). The standard passing score for a GLP course is 80 percent.

Toggle ContentWhat are the advantages of CITI Program's GLP training?

GLP was developed and reviewed by industry experts to provide organizations and individuals with an educational resource that will help ensure compliance with GLP regulations and guidelines. The author has over 28 years of experience in quality assurance and working with EPA, FDA, and OECD-compliant research and testing. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for GLP training.