About the Event

TGA Regulatory Training - Early Bird Pricing Ending Soon!

Don't miss this opportunity to enhance your regulatory expertise at a special introductory rate, coinciding with the launch of the PTA Academy.

Course Details:

Dates: Three separate full days of training.

Foundation Training (2 x 1 Day):

Standard Price: $950 per person (After 11th October)

Non-Members Price: $1250 per person per course

Intermediate Level Training (1 Day):

Standard Price: $950 per person (After 11th October)

Non-Members Price: $1250 per person per course

Course Content:

Foundation Training (14th and 15th November - 2 x One-day Courses):

-Understanding the TGA Structure

-Demystifying IVD Regulations

-Navigating ARTG Entries

-QMS Essentials

-Jargon busting, key definitions

-Sponsor responsibilities

-Manufacturing definitions

-Classification

-Review pathways and more essential topics

Intermediate Level Training (16th November - 1 Day):

-Deep Dive into Conformity Assessment

-Mastering Manufacturer Evidence

-Declaration of Conformity

-IVD Classification

-Market authorization

-Navigating the ARTG

-A deeper understanding of the intended purpose

-Demystifying classification rules

Value of the course:

Expert Guidance: Led by Michelle McNiven, a renowned figure in the IVD reg tech sector with over 25 years of experience.

Practical Insights: Michelle's extensive background ensures deep real-world relevance and context.

Educational Vision: Michelle advises Pathology Technology Australia to develop educational courses that promote a deeper understanding of the IVD regulatory environment.

Course Outcomes:

Equip your company with confident regulatory experts.

Gain a competitive edge in your career.

Acquire in-depth classification rules and conformity assessment knowledge.

Expand your industry network.

Registration:

Spaces are limited. Register here. For enquiries, email ea@pathologytechnology.org.au.

Don't miss this chance to elevate your regulatory knowledge and skills. Act now!

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