Good Laboratory Practice (GLP nonclinical) Online Training Course Description
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.
Topics you’ll learn about in this course include:
- The importance of 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
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.
Learn to comply with GLP rules with online training
- 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.
- It includes GLP case studies to help explain the importance of compliance with GLP principles.
- It is an excellent resource for a blending training experience for laboratory personnel, as an initiation course and as a GLP refresher course.
GLP Case Studies and Checklists
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.
This course is an excellent laboratory personnel training resource. Completing this course will help learners and companies prepare for laboratory accreditation (e.g., as GLP training as a component of accreditation requirements for testing and calibration laboratories in Australia).
Who Will Benefit
This course is intended for all industries developing products that require FDA approval for research or marketing including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. It will be beneficial to anyone planning, conducting, monitoring, managing, supervising, or otherwise supporting non-clinical studies. This program is especially valuable for onboarding any employee involved directly or indirectly in nonclinical study planning and execution, to ensure alignment on GLP culture and fundamentals within your organization prior to engaging in work that impacts GLP compliance.
- Laboratory personnel involved in non-clinical studies
- Quality assurance and quality control professionals
- Regulatory affairs specialists
- Study director
- Facility management
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Archivists
Know Your Faculty
Kelly Thomas, Head Of Quality Assurance (USA)
Highly experienced Quality Assurance / Quality Control / Regulatory Compliance leader with experience in API, biologics / biotech, both aseptic and terminally sterilized manufacturing processes, medical devices, drug / device combination products, and all pharmaceutical dosages (Sterile Injectable, OSD, Controlled Substances, Aerosols).
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.
High degree of quality understanding and ability to apply knowledge of global regulatory requirements particularly with process / equipment validation, new product and technology transfer, lot/process investigations, quality systems, quality control, data trending, lab equipment and validation.
