We offer training courses for:
- Anyone new to regulatory affairs or for those wanting to update their skills and knowledge
- Current marketing and technical staff
- Those of you transitioning into this area or wanting to work in Regulatory Affairs
- On-line learning via Zoom
- In-house face-to-face with your choice of venues (your office or our Glebe office [Sydney, NSW]) (once covid-19 pandemic ceases)
- Minimise your time away from the office
- 1 – 2 hour duration training sessions minimise your staff downtime
- On line training is a cost effective alternative to training your team via a group training session
- RFA’s course design provides targeted training on essential regulatory issues which can be tailored to your business needs
- You’ll receive a thorough understanding of Australia’s regulatory requirements and the impact on your business, so you’ll make more informed decisions and take appropriate action
All sessions include Q + A time.
01. Introduction to Regulatory Affairs in Australia
This 1 hour introductory session will provide you with a solid grounding in the different regulatory requirements in Australia for foods, cosmetics and complementary medicines.
02. Evidence Packages
In this 2 hour session we’ll guide you on how to prepare an evidence package to the TGA’s requirements including the content, how to research, troubleshooting issues and format.
This 1 hour training session will explain the TGA’s labelling order (TGO 92) and how to ensure your labels comply with its requirements using labelling examples and a label template.
04. Product Advertising
This 1 hour training session provides an overview of the Therapeutic Goods Advertising Code and its requirements for all forms of advertising (including social media and advertising to health professionals), approval and complaints process. We’ll guide you through some practical advertising examples to help you ensure your ads comply.
05. Finished product specifications
In this intensive 1 hour session you’ll be introduced by our GMP specialist to the basics of the TGA’s requirements that encompass the content of a finished product specification (FPS). By the end of the session you’ll be familiar with the information that the TGA expects the FPS contain and how to liaise with your manufacturer to develop this document.
06. Stability testing
In this 1 hour session you’ll be introduced and guided through your stability testing TGA responsibilities as a sponsor by our GMP specialist. By the sessions end you’ll be more familiar with the importance of working with a stability testing protocol.
07. Product quality reviews
Our 1 hour training session by our GMP auditing specialist will clarify and guide you through the TGA’s legislative expectations and the importance of developing a well-balanced PQR.
08. GMP agreements
Learn from our GMP specialist in this 1 hour training session on the importance of having an effective GMP agreement in place.
09. Pharmacovigilance obligations
This session covers TGA pharmacovigilance obligations and the mandatory reporting requirements of sponsors who have complementary medicines (AUST L) included on the Australian Register of Therapeutic Goods. All required documents including SOP’s and reporting templates will be provided for your use. The course includes 1 hour of zoom training and a package of comprehensive documents including SOP’s and templates that you can use.
21. Introduction to cosmetic regulations in Australia
This 1 hour training session provides you with the knowledge to determine the acceptability of your ingredients with the cosmetic regulatory requirements.
This 1 hour training session will teach you how to check your cosmetic labels (including claims) to ensure compliance with cosmetic labelling legislation by making use of labelling examples and running through our basic label template.
This 1 hour training session will enable you to assess your food ingredients and determine the different Food Standards that apply.
Learn how to check food product labels to meet the food labelling requirements in this 1 hour training session. We’ll walk you through a label template and provide guidance on the requirements of the Nutrition Information Panel.
BA (Hons), BHSc (Naturopathy), Dip Western HerbMed, Dip Nutrition
BAppSc (Food and Nutrition), MPH (Nutrition)
Senior Regulatory Affairs Associate
Quentin R Blades
MMedSc (Drug Development)