TGA Training Course
TGA Regulations for In Vitro Diagnostics (IVDs): Introductory Course
Unlock
the Essentials of TGA Compliance with Pathology Technology Academy
Course Overview:
Are
you new to the field of In Vitro Diagnostics (IVDs) and looking to build a
strong foundation in regulatory compliance? Our introductory course on
Therapeutic Goods Administration (TGA) regulations is tailored just for you.
This course provides a comprehensive introduction to the regulatory landscape
governing IVDs in Australia, offering vital knowledge to help you navigate and
understand the complexities of TGA requirements.
What You Will Learn:
-Basics of TGA Regulations: Grasp the core elements of the TGA regulatory framework and what it means for IVDs.
-Key Definitions and Terminology: Familiarise yourself with essential terms and concepts crucial to understanding TGA regulations.
-Navigating the ARTG: Learn about the Australian Register of Therapeutic Goods (ARTG), including the processes for market authorisation and conformity assessment.
-Structure of the TGA: Gain insights into the organisational structure and key components of the TGA.
-Roles
and Responsibilities:
Understand the critical roles of sponsors and manufacturers, including their
obligations for ARTG entry and maintaining compliance.
Course Benefits:
-Developed and presented by industry expert Michelle McNiven, this course is a must-have for anyone looking to enhance their understanding of TGA regulations.
-Build a solid foundation in regulatory knowledge, setting the stage for more advanced studies.
-Gain clarity on compliance requirements to ensure your organisation meets all necessary standards.
Learning
Outcomes:
-Understand Key TGA Regulations for IVDs: Develop a foundational understanding of the regulatory framework governing IVDs in Australia.
-Learn Essential Definitions: Master the terminology and definitions critical to navigating TGA regulations.
-Understand
Roles and Responsibilities:
Comprehend the distinct roles of sponsors and manufacturers in the regulatory
landscape.
Who Should Attend?
This course is ideal for professionals new to the IVD sector or those seeking to refresh their knowledge of TGA regulations, including regulatory affairs specialists, quality assurance managers, and product development teams.
Online
Course
$
300
TGA Regulations for In Vitro Diagnostics (IVDs): Introductory Course
Unlock the Essentials of TGA Compliance with Pathology Technology Academy
Course Overview:
Are you new to the field of In Vitro Diagnostics (IVDs) and looking to build a strong foundation in regulatory compliance? Our introductory course on Therapeutic Goods Administration (TGA) regulations is tailored just for you. This course provides a comprehensive introduction to the regulatory landscape governing IVDs in Australia, offering vital knowledge to help you navigate and understand the complexities of TGA requirements.
What You Will Learn:
o Basics of TGA Regulations: Grasp the core elements of the TGA regulatory framework and what it means for IVDs.
o Key Definitions and Terminology: Familiarise yourself with essential terms and concepts crucial to understanding TGA regulations.
o Navigating the ARTG: Learn about the Australian Register of Therapeutic Goods (ARTG), including the processes for market authorisation and conformity assessment.
o Structure of the TGA: Gain insights into the organisational structure and key components of the TGA.
o Roles and Responsibilities: Understand the critical roles of sponsors and manufacturers, including their obligations for ARTG entry and maintaining compliance.
Course Benefits:
o Developed and presented by industry expert Michelle McNiven, this course is a must-have for anyone looking to enhance their understanding of TGA regulations.
o Build a solid foundation in regulatory knowledge, setting the stage for more advanced studies.
o Gain clarity on compliance requirements to ensure your organisation meets all necessary standards.
Learning Outcomes:
o Understand Key TGA Regulations for IVDs: Develop a foundational understanding of the regulatory framework governing IVDs in Australia.
o Learn Essential Definitions: Master the terminology and definitions critical to navigating TGA regulations.
o Understand Roles and Responsibilities: Comprehend the distinct roles of sponsors and manufacturers in the regulatory landscape.
Who Should Attend?
This course is ideal for professionals new to the IVD sector or those seeking to refresh their knowledge of TGA regulations, including regulatory affairs specialists, quality assurance managers, and product development teams.
