Good Laboratory Practice (GLP)

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.

Recommended Use: Required
ID (Language): 16696 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc

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.

Recommended Use: Required
ID (Language): 16697 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16698 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16701 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16699 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16703 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16704 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16702 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16700 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16705 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16708 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16707 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

This module 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 safety data sheets (SDSs) and SOPs.

Recommended Use: Required
ID (Language): 16706 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.

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.

Recommended Use: Required
ID (Language): 16709 (English)
Author(s): Kathryn Hackett-Fields, RQAP-GLP - QualiStat, Inc.