Australian code of GMP for human blood and blood components, human tissues and human cellular therapy products

GMP Training – Australian code of GMP for human blood and blood components, human tissues and human cellular therapy products

Overview

This course applies to manufacturers that undertake the collection, processing, testing, storage, release for supply, and quality assurance of Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.  The purpose of this workshop is to provide participants with an understanding of the Australian Code of GMP for human blood and blood components, human tissues and human cellular therapy products.  The training is based on Version 1.0 April 2013 and TGO 88 requirements.  It also includes any latest guidance and GMP focus areas.

This course can also be offered as a ½ day GMP Refresher Training workshop to meet your annual GMP training requirements.

We regularly offer GMP training courses and events in Adelaide, Auckland, Brisbane, Melbourne, Perth, and Sydney, or in other countries, on an as-needed basis. We also offer all our courses as virtual live workshops.

Australian-code-of-GMP-for-human-blood-and-blood-components-human-tissues-and-human-cellular-therapy-products What you will learn

The course will provide participants with an understanding of:

  • The basic concepts of GMP and the definition of quality and how that applies to their workplace
  • The core elements of a QMS and their importance
  • Corrective and Preventive Actions (CAPA) and how to prevent recurring issues
  • Quality Risk Management and the identification of risks in their department
  • Contamination and cross-contamination control
  • Good documentation practice and data integrity
  • Common inspection deficiencies and how to avoid them

Practical application of the key requirements through activities.

Course materials

Participants will receive a copy of the presentation(s), relevant notes and workshop materials. A certificate of completion will be issued to participants who successfully complete the assessment.

Assessment

A written assessment is conducted online at the end of the course.

GMP Training Course format

The GMP Training Course is a combination of lecture-style learning and active workshop activities with participants working in small groups on assigned tasks.

Who should attend?

  • Quality Assurance personnel
  • Quality Control personnel
  • Operations and Manufacturing personnel
  • Anyone within the GMP industry interested in learning about or improving their knowledge of current GMPs for Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.

AUD$450.00 + 10% GST Full Day Training

AUD$250.00 + 10% GST APVMA GMP Refresher Half Day Training

Prices are per person and include morning tea, lunch and afternoon tea (not included for virtual sessions)

Register for the GMP Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products Training Course below:

If you need any assistance, would like a quote for personalised group training, or just have a general training question don’t hesitate to contact us.