One-on-one personal training courses

 

 

Training for regulatory affairs, marketing and technical staff

Courses are available for complementary medicines, cosmetics and foods.

Via Skype: No need to leave your office. You will have direct one-on-one and private training. 

On-site: Make an appointment for a training session in our office in Glebe, Sydney.

 

Price depends on the length of the course and number of attendees and includes course notes. Except for courses 04 & 05, courses are one hour in duration.

 

Click on the name of the course below for more information.

  • Relevant guidelines, orders and codes,
  • the cosmetic/medicine interface
  • the food/medicine interface

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Complementary Medicines

  • Regulation of medicines in Australia
  • Legislative framework
  • Concept to market
  • Online Listing – TGA eBusiness Services

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  • Overview documentary prerequisites for a listing application
  • Online Listing – eBusiness Services
  • Compiling a product dossier
  • Section 9d, 14 applications
  • Responding to Section 31 requests

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  • General principles: general, medium & high level claims
  • Evidence required to support therapeutic claims
  • TGA’s evidence table requirements

This course is 1 ½  hours long.

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  • Researching and sourcing traditional and scientific evidence
  • Evaluating evidence and proposing acceptable claims and indications
  • Compiling claims bibliography to TGA guidelines

This course is 1 ½  hours long.

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  • Legislative framework
  • Advertising to practitioners
  • Restrictions
  • Applications to advertising clearance bodies

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  • Legislative framework
  • Requirements
  • Restrictions / Warnings

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  • Data requirements
  • Toxicology and human data
  • TGA process and time frames

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  • content and formatting
  • ingredient nomenclature and standards
  • overages
  • test methods
  • setting expiry/release limits

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  • content and formatting - stability protocol and stability test schedule
  • choosing the active ingredients for testing
  • types of test methods, development and validation
  • interpretation of results
  • writing of stability report

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  • The regulatory underpinning of PQRs
  • Establishing responsibilities
  • Overview of the various requirements
  • How to obtain the required data
  • What happens to the final report

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  • What is GMP? Why do we need it?
  • Basic principles of GMP
  • Australia’s regulatory framework
  • How is GMP enforced in Australia

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  • The regulatory requirement for GMP Agreements
  • Why do we require GMP Agreements
  • The format of the GMP Agreement
  • Deciding who has the responsibilities
  • Maintaining the GMP Agreements

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  • Why do we require GMP documentation
  • The regulatory requirements for GMP
  • Types of documents
  • Formatting of GMP documentation
  • Maintaining a documentation system
  • Maintaining quality records
  • SOPs complaints and product recalls procedures

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Cosmetics

  • Ingredient acceptability
  • NICNAS applications exemptions, and annual reporting
  • Poisons schedules and other ingredient restrictions

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  • Labelling and packaging requirements
  • Cosmetic claims versus therapeutic claims

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Foods

  • Determining appropriate food standards
  • Assessing food ingredients - macronutrients
  • Assessing food ingredients – vitamins, minerals and other nutritive substances
  • Assessing food ingredients – processing aids and additives

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  • Purpose of food labels
  • Mandatory information on food labels
  • Claims and food labelling
  • Brief overview of Nutrition Information Panels and ingredient lists
  • Small package labels

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To book a course please call us on +61 2 96608027; or complete the enquiry form:

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