Training provided for regulatory affairs, marketing and technical staff

  • Can be provided via on-line learning delivered via Skype; or,
  • Via face-to-face workshops at our office in Glebe, Sydney
  • Courses are 1 - 1 1/2 hour duration
  • Certificate provided at completion of training

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Course topics:

  • 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

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  • General Principles: non-specific and specific indications; traditional vs scientific

  • Evidence is required to support therapeutic indications and claims
  • Therapeutic Goods Administration (TGA) evidence package 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 an ‘evidence package’ to Therapeutic Goods Administration (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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  • We cover TGA pharmacovigilance obligations and mandatory reporting requirements, the what, how and when you MUST report.
  • All required documents including SOPs and reporting templates will be provided for your future use.

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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

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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

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