IVD Australia

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Training

Technical & Regulatory Training Workshops

Customised Training for Your Company 

Conformity Assessment and Manufacturer’s Evidence remain the biggest challenges and IVD Australia has developed a comprehensive full day training workshop to prepare your staff to undertake compliance activities. 


The following topics are covered in the workshop (these can be modified to suit your needs):

Module 1 – Introduction to the Regulations

  • Background to the TGA Regulations
  • The TGA Jargon Explained
  • The TGA IVD Framework
  • What are my long term responsibilities?
  • What is a Recall?
  • Labelling and advertising of IVDs

Module 2 – Outline of Essential Principles, Classification and Grouping

  • What are Essential Principles?
  • What is an Essential Principles Checklist?
  • Classification of IVDs
  • GMDN Terms and Grouping of IVDs
  • Examples of GMDN Terms and Grouping

Module 3 – Manufacturer’s Evidence

  • What is ISO 13485?
  • What is Conformity Assessment?
  • What is Manufacturers Evidence?
  • What does a Declaration of Conformity look like?
  • What is CMDCAS and what does it mean for Manufacturer’s Evidence?
  • What is the IVDD and what does it mean for Manufacturer’s Evidence

Module 4 – Conformity Assessment

  • What is Conformity Assessment?
  • Conformity Assessment or GMP?
  • Conformity Assessment Elements
  • What’s the Conformity Assessment Process
  • What’s the TGA Role in Conformity Assessment
  • Timeframes for Conformity Assessment
  • Pre-submission meetings
  • The Conformity Assessment Application
  • What happens after the CAC is issued?

Module 5 – Technical File Reviews and Submitting Applications for Inclusion

  • Will my products require a Technical File Review?
  • What is a Technical File?
  • What is a STED?
  • What sort of requests will we get from the TGA?
  • How long do we have to respond to a TGA request?
  • How do we go about making an application for inclusion?
  • How much is it going to cost? 

Presenter:

Dr Peter Harman, immediate past CEO IVD Australia

When:  

When you need it
9:30 am - 4:00pm

Where:

At your place

Cost:

Members: $2,500 + GST (up to 15 people)

Questions?

ea(at)ivd.org.au