Advanced GMP Training (GMP03)
This one day course is updated regularly to provide clients with current GMP trends and information. This course is designed for all people who work in a GMP regulated environment.
For example;
- All Quality Assurance personnel
- All Quality Control personnel
- Operations and Manufacturing personnel
- Validation personnel
As the Australian Code of Good Manufacturing Practice for Medicinal Products states;
“All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs. ”
Learning Objectives and Course Description
This course focuses on advanced cGMP concepts;
- The history of cGMPs and the major precursors to current GMPs and recent GMP trends
- Quality Management, the relationship between Quality Assurance, Quality Control, the GMP codes and Quality Management Systems
- designing systems and documentation for error minimisation, the tips and GMP requirements for designing effective and efficient documentation systems
- management responsibilities in a GMP context
- design deviation management responses to eliminate root causes of deviations, i.e. CAPA
- manage deviations, non conformance and change controls to satisfy GMP requirements
- change management as opposed to change control. Manage change in a controlled, defined and systematic manner to reduce non value added activities
- Risk Based Decision Making, how this can save your business time and money
- develop an internal audit plan and internal audit requirements
- know the GMP requirements for customer complaint handling systems
- GMP requirements for product recall
- understanding of the Risk Based approach
- have a thorough and complete understanding of GMP and the intent of GMPs worldwide
- be able to successfully prepare and participate on a TGA / FDA audit
- be able to adopt the cGMP requirements into their day to day work tasks
- know how to quickly access further cGMP information
- qualified to conduct internal audits
This one day course is intended to provide participants with a working knowledge (illustrated by recent examples) and understanding of the current cGMP.
Benefits include
- learning from experienced professional trainers
- understanding GMP and its applications for shop floor personnel
- one on one tuition during the course as the classes and are small and intimate
- receipt of a complete training kit, trainer’s notes and a certificate of completion for participants assessed.
View schedule and how to make a booking.
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