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

You choose:

  • On-line learning (Zoom or Skype)
  • Face-to-face (once covid-19 pandemic ceases)

Benefits:

  • Cost effective
  • Time effective (1 – 2 hour duration)
  • Grow your skills quickly

 

Topics:

01. Introduction to Regulatory Affairs in Australia  

Practical, introductory session which will provide you with a solid grounding of the regulatory requirements in Australia for foods, cosmetics and complementary medicines.

Complementary Medicines

02. Evidence Packages

In this 2 hour session we guide you on how to prepare an evidence package to TGA requirements. The format, content, troubleshooting issues and how to research.

03. Labels

The requirements of TGO 92 (the labelling order), explained. Learn how to check your label for compliance. Session includes a label template and example.  

04. Product Advertising

The Therapeutic Goods Advertising Code – an overview of the requirements of the advertising code so you can ensure your ads comply.

05. Finished product specifications

06. Stability testing

07. Product quality reviews

08. GMP agreements

09. Pharmacovigilance obligations

Cosmetics

21. Introduction to cosmetic regulations in Australia

Gives you the knowledge of cosmetic regulatory requirements.

22. Labels

Learn how to check your cosmetic labels for compliance against relevant cosmetic labelling legislation.

Foods

31. Ingredients

Learn how to assess food ingredients, which standard to apply.

32. Labels

Learn how to label food products to legislative requirements. Includes template and guidance on Nutrition Information Panel requirements.

 

Our Trainers:

Ellie Kim   BMedSc, BHSc (Chinese Med), MHerbMed (Hons)

Regulatory Affairs Manager

 ELLIE

 

Kate Durey    BA (Hons), BHSc (Naturopathy), Dip Western HerbMed, Dip Nutrition

Training Manager

KATE crop

 

Samantha King   BAppSc (Food and Nutrition), MPH (Nutrition)

Senior Regulatory Affairs Associate

SAMANTHA crop

 

Quentin R Blades   MMedSc (Drug Development)

GMP Specialist

QUENTIN

 

To book a course, enquire about pricing, or if you have any questions on the topics covered or your suitability for training,  contact us at +61 2 96608027; or  This email address is being protected from spambots. You need JavaScript enabled to view it.; or via the training form below:

Training Form

Contact Name: 
Email: 
Company: 
Which courses are you interested in: 
Please enter the following fsbrb Help us prevent SPAM!
    
Go to top