Lesson series

Good Laboratory Practices for Non‑Clinical Studies 

From discovery to the clinic - with confidence. Ensure the quality of the data that supports your program.
Advancing a therapeutic candidate from discovery to the clinic demands rigorous, well‑designed, and well‑documented pre‑clinical testing. Whether studies are conducted in house or outsourced the teams responsible for them are required to be adequately trained and equipped with knowledge to operate within a compliant quality framework.

The Organisation for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP) define the quality system governing the planning, conduct, monitoring, recording, reporting, and archiving of non‑clinical safety studies. This short course introduces the foundational principles, expectations, and operational requirements of both OECD Principles of GLP and the US FDA CFR Part 58 GLP for Non-Clinical Studies as they apply to early‑stage drug development in preparation for non‑clinical safety studies.

Our full-day in person course is designed for organisations transitioning from exploratory R&D into regulated non‑clinical safety testing, where assay development, method qualification, and production of GLP batches are critical to study integrity, traceability and reproducibility.

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Who is this course for?

  • Pharmaceutical and early-stage biotech companies preparing for first in human programs
  • University staff and R&D scientists 
  • Teams producing GLP test articles and products for non-clinical studies
  • Drug development, assay development and method qualification teams supporting GLP studies
  • Quality, compliance, and operational staff establishing GLP aligned systems
  • Anyone responsible for documentation, data integrity, or study support activities internally or managing external providers

Classroom Training

This full-day course is delivered in person via a combination presentations, discussion and active workshops. Participants will work in small groups on exercises and case studies for experiential application of GLP principles.

Assessment

Upon completion of the in person course delivery attendees will complete an online assessment of the content that has been delivered.

Resource Library

Attendees will access a curated library of relevant resources and supplementary materials to broaden their knowledge and assist application in workplace.

Join our alumni network

Upon completion of the course, participants can join our alumni network along with other participants from across Australia.

Case studies 

All CBE training programs use case studies, straight from industry to give participants a real-world, industry based perspective.

Graduation Pack

All graduates receive a Graduation Pack, which includes a certificate of completion, course credential badge and digital asset.

Meet your trainers for this course

Our trainers have decades of industry knowledge, technical expertise and practical experience across all aspects of the biopharmaceutical sector. 

Steve Williams

Course Trainer

With over 50 years experience in the Biotechnology, Pharmaceutical and Medical Device industries, Steve provides strategic solutions to regulatory and compliance challenges, along with advanced training courses. He has over 25 years consulting experience in GMPs, Compliance, Auditing, Training and Quality Systems to all international standards.

Lisa Bennett

Course Trainer

Lisa has a diverse background from R&D to aseptic processing and sterile medicine manufacture to Quality Management Systems and auditing. Lisa has held industry roles in the manufacture of sterile products.
She volunteers with the Parenteral Drug Association (PDA). Lisa actively engages with industry stakeholders, collaborators on knowledge sharing opportunities such as conferences workshops, training and publications, and stays abreast of regulators' expectations.

Interested in this GLP Training Course?

Share a few details to register your interest in this course and our team will contact you to discuss options and scheduling details.