Introduction to the Australian Therapeutic Goods Regulations for IA

Introduction to the Australian Therapeutic Goods Regulations for Internal Auditors

Introduction to the Australian Therapeutic Goods Regulations for IA

Level Internal auditor Duration 3 hours

Available to book: Public classroom Request more information

To address the on-going concerns of Medical Device Directives and Regulations in Australia, organizations must demonstrate their commitment to the safety and quality of their products. An ineffective audit can mean severe consequences, resulting in process failure, customer dissatisfaction and regulatory non-compliance.

This course enables a clause-by-clause understanding of ISO 13485, which outlines the comprehensive requirements of an effective QMS. Develop your understanding of Australian Quality Systems Regulations and what to consider when auditing in conjunction with ISO 13485.

How will I benefit?

This course will help you:

Prepare, conduct and follow-up on ISO 13485 compliant QMS audit activities
Gain the skills to assess an organization’s capability to manage its Quality Management System
Offer confidence to customers and suppliers that a device meets regulatory requirements
Write factual audit reports and suggest corrective actions
Enhance customer satisfaction though effective audit application and commitment to continual improvement

You will learn about:
- Australian Therapeutic Goods (Medical Devices) Regulation requirements
- What to consider when auditing the requirements as part of an internal audit in conjunction with ISO 13485
- Quality Managers
- Internal Auditors
- Regulatory Affairs Managers
Note: Existing knowledge of the Australian Quality System Regulations is a pre-requisite for this course.
- Training course notes
- Lunch

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