Good Laboratory Practice (GLP nonclinical)

Good Laboratory Practice (GLP nonclinical)

$60.00

Course duration: Allow 3 to 4 hours to complete this course.

Description

Good Laboratory Practice (GLP nonclinical) online training course

This Good Laboratory Practice (GLP) nonclinical training course introduces learners to the general requirements for the competence of testing and calibration laboratories as outlined in ISO/IEC 17025:2017.

  • Impartiality and confidentiality
  • Laboratory organisation and management structure
  • Resources – personnel, facilities, environment and equipment
  • Metrological traceability
  • Test methods and method validation
  • Sampling plan and sampling method
  • Evaluation of measurement uncertainty
  • Technical records
  • Test results and reporting
  • Complaints and nonconformance handling
  • Management system – documentation, corrective actions, internal audits and management reviews

Course Duration – approx. 3 to 4.5 hours

Please note that online course completion times will vary from learner to learner and from course to course.

This Good Laboratory Practice (GLP) training course is designed to suit individuals looking to understand the principles of GLP, and GLP compliance requirements, in non-clinical laboratories.

  • The GLP training course, available completely online, delves into how the concept of good laboratory practice came into effect as a regulatory standard.
  • It provides helpful information on documents published to ensure GLP compliance is well understood and followed worldwide, including internal GLP Audit checklists for GMP compliance monitoring.

There are also case studies reviewed within the course to help explain the importance of compliance with GLP principles.

These case studies, along with the information and Good Laboratory Practice (GLP) checklists provided in this online GLP course, can help laboratory organisations (including University Laboratories) identify potential GLP gaps within their laboratory facilities, research teams, and/or their laboratory research/testing processes (e.g. their standard operating procedures/SOPs).

OECD’s Principles of GLP

  • GLP training courses are imperative for individuals and research institutions/organisations with laboratory operations.
  • This Good Laboratory Practice (GLP) training course will introduce learners to the OECD Principles of GLP.
    • These principles were compiled by the OECD (Organisation for Economic Co-operation and Development) to ensure the generation of high quality and reliable test data by laboratories conducting non-clinical studies.
    • These principles are used to regulate laboratories in Australia and many other countries.

Why is understanding compliance requirements for Good Laboratory Practice (GLP) crucial for laboratory teams and other relevant personnel?

Complying with OECD GLP principles is are an imperative step for future drug development applications to regulatory authorities, such as the FDA, TGA, EMA, MHRA, NMA, AMA and other regulatory authorities who review new drug applications/marketing authority applications.

OECD-good-laboratory-practice GLP-principles_OECDs.j

Accreditation of testing and calibration laboratories in Australia

This GLP course will also introduce learners to the general requirements for the competence of testing and calibration laboratories as outlined in ISO/IEC 17025:2017.

  • Impartiality and confidentiality
  • Laboratory organisation and management structure
  • Resources – personnel, facilities, environment and equipment
  • Metrological traceability
  • Test methods and method validation
  • Sampling plan and sampling method
  • Evaluation of measurement uncertainty
  • Technical records
  • Test results and reporting
  • Complaints and nonconformance handling
  • Management system – documentation, corrective actions, internal audits and management reviews

Online Training for Good Laboratory Practice (GLP) Training

Course Duration (Average course completion time frames):

Completion timeframes for the online GLP training course will generally range from 3 to 4 hours total, including the Final Assessment. However, GLP compliance training course completion times can vary depending on the learner’s familiarity with laboratory work and GLP concepts, and individual learning capacities.

Note: Course completion time frames may vary from learner to learner and depend on numerous factors.

How long will it take me to complete this Good Laboratory Practice/GLP training course?

Average timeframes for course completion of the GLP course:

On average, allow 3 hours to 4.5 hours for completion of this training course, including the online Final Assessment that provides learners with a Certificate of Completion for this GLP training course.


Examples of Regulators: Abbreviated list of Government Regulatory Agencies in relation to pharmaceutical products and marketing authority applications/approvals for medicinal products:

Note: Read more about which authorities monitor GMP compliance for pharmaceutical manufacturing / medical products.