Training for regulatory affairs and technical staff, now available as one-hour modules via Skype.
No need to leave your office. Select from a number of one hour courses. You will have direct one-on-one and private contact. Select the training you need and proceed to our shopping cart to have us contact you for an appointment or contact our office for details.
Click on the course for more information.
- Relevant guidelines, orders and codes,
- the cosmetic/medicine interface
- the food/medicine interface
Complementary Medicines
- Regulation of medicines in Australia
- Legislative framework
- Concept to market
- Online Listing – eBusiness Services
- Overview documentary prerequisites for a listing application
- Online Listing – eBusiness Services
- Compiling a product dossier
- Section 9d, 14 applications
- Responding to Section 31 requests
- General principles: general, medium & high level claims
- Evidence required to support therapeutic claims
- TGA’s evidence table requirements
- Researching and sourcing traditional and scientific evidence
- Evaluating evidence and proposing acceptable claims and indications
- Compiling claims bibliography to TGA guidelines
- Legislative framework
- Advertising to practitioners
- Restrictions
- Applications to advertising clearance bodies
- Legislative framework
- Requirements
- Restrictions / Warnings
- Data requirements
- Toxicology and human data
- TGA process and time frames
- Content and formatting
- Ingredient nomenclature and standards
- Overages
- Test methods
- Setting expiry/release limits
- 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
- The regulatory underpinning of PQRs
- Establishing responsibilities
- Overview of the various requirements
- How to obtain the required data
- What happens to the final report
- What is GMP, why do we need it
- Basic principles of GMP
- Australia's regulatory framework
- How is GMP enforced in Australia
- The regulatory requirement for GMP Agreements
- Why do we require GMP Agreements
- The format of the GMP Agreement
- Deciding who has the responsibilities
- Maintaining GMP Agreements
- Why do we require GMP documentation
- The regulatory requirements for GMP
- Types of documents
- Formatting GMP documentation
- Maintaining a documentation system
- Maintaining quality records
Cosmetics
- Ingredient acceptability
- NICNAS applications, exemptions, and annual reporting
- Poisons schedules and other ingredient restrictions
- Labelling and packaging requirements
- Cosmetic claims versus therapeutic claims
Foods
Food courses to be announced soon!
