Your training partner for regulatory affairs

Regulatory Training Direct

Regulatory Training Direct provides online training for the Health Products industry. Our expert trainers have over 100 years of combined experience in various aspects of regulatory affairs.

Our training courses have been developed to provide up-to-date and easy to understand information on the regulatory requirements for listed complementary medicines, dietary supplements, food products and cosmetics.

We understand the complexities and major pitfalls and can teach you how to navigate the regulatory framework to help develop and maintain compliant products in the market.

Our training courses have been tried and tested, delivered for decades under RFA Regulatory Affairs. Today, the courses have been optimised for delivery through a dedicated training company – Regulatory Training Direct.

Our courses cover regulations in Australia, New Zealand and the USA.

View our Course Summary

Who is the training for?

Sponsors, brand marketers, contract manufacturers, established brands, new-comers, social media influencers, and people wanting to move into a different department.

Our courses cover vast aspects of regulations including GMP, pharmacovigilance, evidence packages, labelling, etc.

Our courses are designed for:

Sponsors/Brand Marketers/contract manufacturers/laboratories wanting to keep their regulatory, quality and product development teams up-to-date with regulatory affairs.
Individuals wanting to upskill their regulatory knowledge for career progression.
Individuals and companies that are just starting out and want to learn from seasoned professionals.
Companies wanting to export into new markets.

Meet the Trainers

How is our training delivered?

We are an online training company. Our training modules are delivered direct to you from the comfort of your office. We have two training options available:

Live training personal tuition sessions with an expert presenter conducted via Zoom. This option allows for Q&A and a more interactive experience.
eLearning delivered by our expert presenters via pre-recorded training modules on our eLearning platform. This option includes recordings available on demand and can be completed at your own pace.

Book a LIVE course Book an eLearning Course

What do I get?

Live Training (personal tuition)	e-Learning Training
Course notes Templates, resources, and SOPs (where relevant) Case studies Content delivered live to you by our expert trainer Opportunity for Q&A Certificate	Course notes Templates, resources, and SOPs (where relevant) Case studies Pre-recorded content available on demand Unlimited access for 60-days Certificate

Course Summary

Click on title to view agenda and pricing.

Australia

1.01. Introduction to Regulatory Affairs in Australia - listed medicines, low risk medical devices, foods, cosmetics

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Course Description
1.01. Introduction to Regulatory Affairs in Australia – listed medicines, low risk medical devices, foods, cosmetics	1 hr	$495 Book now	$396 Available now	The interface between Australian regulatory pathways Regulation of listed medicines Regulation of low risk medical devices Regulation of foods Products that overlap – sports supplements Regulation of cosmetics Cosmetics vs medicines Products that overlap – sunscreens Importing products into Australia How to determine the classification of your product

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Course Description

1.01. Introduction to Regulatory Affairs in Australia – listed medicines, low risk medical devices, foods, cosmetics

1 hr

$495

Book now

$396

Available now

The interface between Australian regulatory pathways
Regulation of listed medicines
Regulation of low risk medical devices
Regulation of foods
Products that overlap – sports supplements
Regulation of cosmetics
Cosmetics vs medicines
Products that overlap – sunscreens
Importing products into Australia
How to determine the classification of your product

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars

AU Complementary Medicines

1.02. TGA evidence requirements for claims

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.02.TGA evidence requirements for claims	3 hr 30min	$1,950 Book now	$1,560 Available now	Part 1 – Foundations Regulatory Framework Overarching principles Types of indications Types of evidence Minimum evidence requirements TGA evidence package requirements Part 2 – Researching How to find evidence – literature searches How to find evidence – sources of evidence How to utilise electronic databases How to assess evidence – relevance How to assess evidence – quality How to assess evidence – balance Part 3 – Compiling an evidence package Overview TGA checklists General requirements (cover page) Evidence search strategy Evidence filters Evidence summaries Critical appraisals Justifications This course includes extensive resources and templates. Attendees receive a list of evidence sources and a user-friendly evidence package template. The course also includes hints, tips, examples and case studies.

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.02.TGA evidence requirements for claims

3 hr 30min

$1,950

Book now

$1,560

Available now

Part 1 – Foundations

Regulatory Framework
Overarching principles
Types of indications
Types of evidence
Minimum evidence requirements
TGA evidence package requirements

Part 2 – Researching

How to find evidence – literature searches
How to find evidence – sources of evidence
How to utilise electronic databases
How to assess evidence – relevance
How to assess evidence – quality
How to assess evidence – balance

Part 3 – Compiling an evidence package

Overview
TGA checklists
General requirements (cover page)
Evidence search strategy
Evidence filters
Evidence summaries
Critical appraisals
Justifications

This course includes extensive resources and templates. Attendees receive a list of evidence sources and a user-friendly evidence package template. The course also includes hints, tips, examples and case studies.

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.03. Listed medicine labels

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.03. Listed medicine labels	1 hr	$495.00 Book now	$396.00 Coming soon	Regulatory framework Label presentation Listed medicine presentation Label inclusions Label statements Regulations – TGO 92 “Labelling order” Regulations Permitted ingredients Permitted indications Regulations – advisory statements Regulations – poisons Regulations – advertising and trade descriptions Label requirements Restrictions and warnings How to prepare your medicine label Example product Stress + Fatigue Active ingredients on the finished prod specifications Finding label information on TBS listing application Example product label Checklist SOP for labels provided

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.03. Listed medicine labels

1 hr

$495.00

Book now

$396.00

Coming soon

Regulatory framework
Label presentation
Listed medicine presentation
Label inclusions
Label statements
Regulations – TGO 92 “Labelling order”
Regulations
Permitted ingredients
Permitted indications
Regulations – advisory statements
Regulations – poisons
Regulations – advertising and trade descriptions
Label requirements
Restrictions and warnings
How to prepare your medicine label
Example product Stress + Fatigue
Active ingredients on the finished prod specifications
Finding label information on TBS listing application
Example product label
Checklist SOP for labels provided

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.04. Product Advertising - superseded by 1.17.

Course Name	Duration	Personl Tuition Course Cost*	e-Learning Course Cost*	Agenda
Course Name	Duration	1.04. Product Advertising – superseded – refer to course 1.17.	–	Agenda	no longer available	no longer available	This course has been replaced by 1.17 Advertising medicines and medical devices

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.05. Specifications

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.05. Specifications	2 hr	$1500 Book now	$792 Coming soon	Regulatory framework Legislative resources Attachments Definitions Default standards The Supplier’s Raw Material Specification This comes from the supplier of the ingredient to be used in manufacture; Mandatory inclusions including identification and test limits Proprietary ingredients Approval of supplier Common shortcomings Example supplier specifications provided The Manufacturer’s Starting Material Specification Developed by the product manufacturer in accordance with GMP Mandatory inclusions Additional tests and alternate suppliers Example manufacturer starting material specification provided The Sponsor’s Finished Product Specifications (FPS) The sponsor’s description of the finished packaged product Legislative framework How to prepare, understand and ensure compliance of the FPS General information required – description, packaging, storage, tests and limits Specific information on active and nonactive ingredients Overages and release and expiry limits Assays required Information needed for herbal ingredients Example FPS provided Attachments supplied: Supplier raw material specification: ascorbic acid Manufacturer starting material specification: ascorbic acid Sponsor finished product specifications: Stress + Fatigue BP Monograph: ascorbic acid and 5a: EP Uniformity of mass Compositional monograph: Rhodiola rosea FPS template for hard capsule FPS template for oral powder FPS template for chewable tablets FPS template for dispersible tablets FPS template for enteric coated hard capsules FPS template for enteric coated soft capsules FPS template for enteric coated tablets FPS template for sustained and modified release tablets FPS template for topical liquids

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.05. Specifications

2 hr

$1500

Book now

$792

Coming soon

Regulatory framework
Legislative resources
Attachments
Definitions
Default standards

The Supplier’s Raw Material Specification

This comes from the supplier of the ingredient to be used in manufacture;

Mandatory inclusions including identification and test limits
Proprietary ingredients
Approval of supplier
Common shortcomings
Example supplier specifications provided

The Manufacturer’s Starting Material Specification

Developed by the product manufacturer in accordance with GMP

Mandatory inclusions
Additional tests and alternate suppliers
Example manufacturer starting material specification provided

The Sponsor’s Finished Product Specifications (FPS)

The sponsor’s description of the finished packaged product

Legislative framework
How to prepare, understand and ensure compliance of the FPS
General information required – description, packaging, storage, tests and limits
Specific information on active and nonactive ingredients
Overages and release and expiry limits
Assays required
Information needed for herbal ingredients
Example FPS provided

Attachments supplied:

Supplier raw material specification: ascorbic acid
Manufacturer starting material specification: ascorbic acid
Sponsor finished product specifications: Stress + Fatigue
BP Monograph: ascorbic acid
and 5a: EP Uniformity of mass
Compositional monograph: Rhodiola rosea
FPS template for hard capsule
FPS template for oral powder
FPS template for chewable tablets
FPS template for dispersible tablets
FPS template for enteric coated hard capsules
FPS template for enteric coated soft capsules
FPS template for enteric coated tablets
FPS template for sustained and modified release tablets
FPS template for topical liquids

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.06. Stability testing

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.06. Stability testing	2.0 hr	$1,200.00 Book now	$594 Coming soon	Regulatory framework What is the purpose of stability testing? Who performs stability testing? When is stability testing carried out? Listed medicines: estimating shelf life Overages Stability testing: budget Stability samples: packaging Stability samples: storage conditions Storage conditions: high humidity Two phases of stability testing Initial stability testing Methodology Accelerated stability testing On-going stability testing Documentation of the stability testing process Monitoring the stability testing results Examples Example: Stability testing schedule Includes an example of a stability testing protocol, and a stability testing schedule based on a finished product specification for a hypothetical product. These documents can be adapted by your business and utlised when developing your unique stability testing protocols and schedules

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.06. Stability testing

2.0 hr

$1,200.00

Book now

$594

Coming soon

Regulatory framework
What is the purpose of stability testing?
Who performs stability testing?
When is stability testing carried out?
Listed medicines: estimating shelf life
Overages
Stability testing: budget
Stability samples: packaging
Stability samples: storage conditions
Storage conditions: high humidity
Two phases of stability testing
Initial stability testing
Methodology
Accelerated stability testing
On-going stability testing
Documentation of the stability testing process
Monitoring the stability testing results
Examples
Example: Stability testing schedule
Includes an example of a stability testing protocol, and a stability testing schedule based on a finished product specification for a hypothetical product. These documents can be adapted by your business and utlised when developing your unique stability testing protocols and schedules

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.07. Product Quality Reviews

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.07. Product Quality Reviews	1 hr	$495 Book now	$396 Coming soon	An overview of Product Quality Reviews – mandatory GMP requirement. Introduction Objectives of Product Quality Reviews (PQR) Scope and Content of PQRs Frequency of PQRs Responsibilities for PQR Manufacturer’s Responsibilities Sponsor’s Responsibilities Authorised Person’s Responsibilities PQR by Exception Review of the PQR

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.07. Product Quality Reviews

1 hr

$495

Book now

$396

Coming soon

An overview of Product Quality Reviews – mandatory GMP requirement.

Introduction
Objectives of Product Quality Reviews (PQR)
Scope and Content of PQRs
Frequency of PQRs
Responsibilities for PQR
Manufacturer’s Responsibilities
Sponsor’s Responsibilities
Authorised Person’s Responsibilities
PQR by Exception
Review of the PQR

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.08. GMP agreements

Course Name	Duration	Personl Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.08. GMP agreements	1 hr	$495 Book now	$396 Coming soon	An overview on this mandatory agreement between product sponsor and all manufacturers involved in production. Allocating who is responsible for each step in manufacture Which responsibilities can be shared Listing of relevant finished products in annex A typical example of a GMP agreement Template provided

Course Name

Duration

Personl Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.08. GMP agreements

1 hr

$495

Book now

$396

Coming soon

An overview on this mandatory agreement between product sponsor and all manufacturers involved in production.

Allocating who is responsible for each step in manufacture
Which responsibilities can be shared
Listing of relevant finished products in annex
A typical example of a GMP agreement
Template provided

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.09. Preparing and submitting a listed medicine application

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.09. Preparing and submitting a listed medicine application	1.5 hr	$742 Book now	$594 Coming soon	Regulatory framework Steps in preparing a listing application Prerequisites for the listing application Sponsor ID Authority to prepare / submit Required documentation / information Determine the medicine is eligible for listing Preparation of the listing application Validation of the listing application Submission of the listing application Certification / Declaration Conditions of listing Listing application tips Example listing application SOP Checklist supplied This course includes access to TGA Business Services (TBS) through RTD’s organisation for one participant. This one participant will be guided through the process of preparing and validating a listing application based on a mock Finished Product Specification prepared by RTD. This practical part of the session only allows for one participant to engage in the process of preparing and validating a listing application. If you book a session for multiple attendees, we recommend all participants be present in the same room so a large screen can be shared for the other participants to view the process. If all participants want TBS access and to prepare and validate a listing application during the live training separate course sessions will need to be booked and this will be changed accordingly.

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.09. Preparing and submitting a listed medicine application

1.5 hr

$742

Book now

$594

Coming soon

Regulatory framework
Steps in preparing a listing application
Prerequisites for the listing application
Sponsor ID
Authority to prepare / submit
Required documentation / information
Determine the medicine is eligible for listing
Preparation of the listing application
Validation of the listing application
Submission of the listing application
Certification / Declaration
Conditions of listing
Listing application tips
Example listing application
SOP Checklist supplied
This course includes access to TGA Business Services (TBS) through RTD’s organisation for one participant. This one participant will be guided through the process of preparing and validating a listing application based on a mock Finished Product Specification prepared by RTD. This practical part of the session only allows for one participant to engage in the process of preparing and validating a listing application. If you book a session for multiple attendees, we recommend all participants be present in the same room so a large screen can be shared for the other participants to view the process. If all participants want TBS access and to prepare and validate a listing application during the live training separate course sessions will need to be booked and this will be changed accordingly.

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.10. New substance applications

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.10. New substance applications	1.5 hr	$742 Book now	$594 Coming soon	Part 1 The TGA regulatory framework Overview ‘Permissible’ ingredient Application categories Comparable Overseas Body Mandatory requirements Part 2 Quality Default standard v compositional guideline Batch analysis Stability Part 3 Safety Systematic literature review ‘Safety’ studies Market data Part 4 Important considerations TGA approval, including an exercise Market exclusivity and ‘concurrent’ submissions Pre-submission advice Feasibility Part 5 Useful links Part 6 Resources

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.10. New substance applications

1.5 hr

$742

Book now

$594

Coming soon

Part 1 The TGA regulatory framework

Overview
‘Permissible’ ingredient
Application categories
Comparable Overseas Body
Mandatory requirements

Part 2 Quality

Default standard v compositional guideline
Batch analysis
Stability

Part 3 Safety

Systematic literature review
‘Safety’ studies
Market data

Part 4 Important considerations

TGA approval, including an exercise
Market exclusivity and ‘concurrent’ submissions
Pre-submission advice
Feasibility

Part 5 Useful links

Part 6 Resources

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.11. Herbal Fundamentals

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
Course Name	Duration	1.11. Herbal Fundamentals		Agenda	coming soon	Coming soon	Fundamentals of herbal materials Herbal nomenclature (genus, species) Synonyms Plant parts Plant preparations Extract ratios (native and final) Solvents Temperature and pressure effects Carriers (functional vs dilution) Standardisation Default monographs (key global pharmacopoeias and reference standards) Adulteration Contamination Supplier qualification Raw material specifications Finished product specifications Testing herbal materials Linking herbal preparations to literature

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.12. Compliance Obligations for Listed Complementary Medicines

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.12. Compliance Obligations for Listed Complementary Medicines	3 hours	$1,500 Book now	Coming soon	The perfect course for companies wanting to export to Australia who may have products classified as “dietary supplements” in their own country, who will need to become familiar with Australia’s regulations for complementary medicines. Also useful for newcomers or cosmetic and food brands expanding into this category. Includes guidance on ingredients, claims, labelling, manufacturing standards and ongoing compliance after the product is on the market. This course teaches you: Regulatory framework Formula and claims are publicly visible Register with TGA as a sponsor, authorise an agent(s) Manufacturing Ingredients Therapeutic indications and product claims Evidence to substantiate therapeutic indications Pharmacovigilance Stability testing Labelling and advertising TGA Fees Prerequisites for ARTG listing Dossier for listed medicines Ongoing compliance of ARTG listings TGA compliance monitoring

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.12. Compliance Obligations for Listed Complementary Medicines

3 hours

$1,500

Book now

Coming soon

The perfect course for companies wanting to export to Australia who may have products classified as “dietary supplements” in their own country, who will need to become familiar with Australia’s regulations for complementary medicines. Also useful for newcomers or cosmetic and food brands expanding into this category. Includes guidance on ingredients, claims, labelling, manufacturing standards and ongoing compliance after the product is on the market.

This course teaches you:

Regulatory framework
Formula and claims are publicly visible
Register with TGA as a sponsor, authorise an agent(s)
Manufacturing
Ingredients
Therapeutic indications and product claims
Evidence to substantiate therapeutic indications
Pharmacovigilance
Stability testing
Labelling and advertising
TGA Fees
Prerequisites for ARTG listing
Dossier for listed medicines
Ongoing compliance of ARTG listings
TGA compliance monitoring

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU and NZ Pharmacovigilance

1.15. Pharmacovigilance obligations

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.15. Pharmacovigilance obligations	2 hr	$2,200 Book now	$1,760 Coming soon	What is pharmacovigilance Pharmacovigilance terminology Responsibilities for pharmacovigilance activities What needs to be reported Reporting timeframes How to report Record keeping requirements Pharmacovigilance system Summary of attachments provided References Includes full set of 19 SOPs and Forms that together comprise a complete pharmacovigilance system that can be implemented by your business

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.15. Pharmacovigilance obligations

2 hr

$2,200

Book now

$1,760

Coming soon

What is pharmacovigilance
Pharmacovigilance terminology
Responsibilities for pharmacovigilance activities
What needs to be reported
Reporting timeframes
How to report
Record keeping requirements
Pharmacovigilance system
Summary of attachments provided
References
Includes full set of 19 SOPs and Forms that together comprise a complete pharmacovigilance system that can be implemented by your business

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU Recalls

1.16. Product recalls - medicines, medical devices, foods, cosmetics

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
Course Name	Duration	1.16. Product recalls – medicines, medical devices, foods, cosmetics	Coming soon	Agenda	Coming soon	Coming soon	this course will cover the procedures involved with recalls of medicines, medical devices, foods and cosmetics

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU Advertising

1.17. Advertising medicines and medical devices

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.17. Advertising medicines and medical devices	2.5 hour	$1,240 Book now	$992 Coming soon	What is an advertisement Legislation General principles Restricted representations Mandatory information requirements Scientific and clinical information Specific requirements Testimonials and endorsements Advertising to practitioners Other claims – green, natural Social media How the TGA manages non-compliance Useful TGA advertising guidance ACCC social media advertising and selling guides

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.17. Advertising medicines and medical devices

2.5 hour

$1,240

Book now

$992

Coming soon

What is an advertisement
Legislation
General principles
Restricted representations
Mandatory information requirements
Scientific and clinical information
Specific requirements
Testimonials and endorsements
Advertising to practitioners
Other claims – green, natural
Social media
How the TGA manages non-compliance
Useful TGA advertising guidance
ACCC social media advertising and selling guides

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU GMP Clearance of Overseas Manufacturers

1.18. GMP clearance of overseas manufacturers

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
Course Name	Duration	1.18. GMP clearance of overseas manufacturers	Coming soon	Agenda	Coming soon	Coming soon	this course goes through the process of applying for clearance of overseas manufacturers, including those in countries that Australia has a mutual recognition agreement with, and those that do not,. All types of medicines including complementary medicines that may not be regulated as medicines in the country of manufacture.

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU Cosmetics

1.20. AU Cosmetic Claims and Labelling

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.20. AU Cosmetic Claims and Labelling	2 hrs	$990 Book now	$792 Coming soon	Regulatory framework What is a cosmetic and how does it work Legislation and government agencies Permitted ingredients What is a “naturally occurring” chemical How to search the inventory of industrial chemicals Chemical introductions Registration of the importer Safety data sheets Cosmetic claims Examples of cosmetic vs therapeutic claims Making “green”, “natural”, “anti-ageing” claims Examples of permitted and non-permitted claims for anti-ageing, cleansers, moisturisers Advertising – including social media Certifying bodies Claims for sunscreens Cosmetic labels Mandatory requirements Common mistakes and recalls

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.20. AU Cosmetic Claims and Labelling

2 hrs

$990

Book now

$792

Coming soon

Regulatory framework

What is a cosmetic and how does it work
Legislation and government agencies
Permitted ingredients
What is a “naturally occurring” chemical
How to search the inventory of industrial chemicals
Chemical introductions
Registration of the importer
Safety data sheets

Cosmetic claims

Examples of cosmetic vs therapeutic claims
Making “green”, “natural”, “anti-ageing” claims
Examples of permitted and non-permitted claims for anti-ageing, cleansers, moisturisers
Advertising – including social media
Certifying bodies
Claims for sunscreens

Cosmetic labels

Mandatory requirements
Common mistakes and recalls

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU Sports Supplements

1.30. AU Sports Supplements - medicine or food?

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.30. AU Sports Supplements – medicine or food?	1 hr	$495 Book now	$396 Coming soon	Regulation of sports products in Australia When is the product classified as a food When is the product classified as a medicine The different requirements for each

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.30. AU Sports Supplements – medicine or food?

1 hr

$495

Book now

$396

Coming soon

Regulation of sports products in Australia
When is the product classified as a food
When is the product classified as a medicine
The different requirements for each

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU Sunscreens

1.40. Sunscreens– medicine or cosmetic?

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.40. Sunscreens– medicine or cosmetic?	1 hr	$495 Book now	$396 Coming soon	Regulatory categories of sunscreens Sunscreens regulated by the TGA as medicines Permitted ingredients TGA applications Labels and claims Excluded sunscreens regulated as cosmetics Ingredients, labels and claims

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.40. Sunscreens– medicine or cosmetic?

1 hr

$495

Book now

$396

Coming soon

Regulatory categories of sunscreens
Sunscreens regulated by the TGA as medicines
Permitted ingredients
TGA applications
Labels and claims
Excluded sunscreens regulated as cosmetics
Ingredients, labels and claims

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU Medical Devices

1.41. Medical Device Regulation Fundamentals

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.41. Medical Device Regulation Fundamentals	1.5 hr	$742 Book now	$594 Available now	Overview of medical device regulation in Australia Risk Classification Conformity Assessment Essential Principles Post-market Requirements Registration pathway for medical devices in Australia Update on regulatory reforms for medical devices

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.41. Medical Device Regulation Fundamentals

1.5 hr

$742

Book now

$594

Available now

Overview of medical device regulation in Australia
Risk Classification
Conformity Assessment
Essential Principles
Post-market Requirements
Registration pathway for medical devices in Australia
Update on regulatory reforms for medical devices

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.42. Medical Device Classification

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.42. Medical Device Classification	1 hr	$495 Book now	$396 Available now	Background to medical device classification Basics of classification in Australia Rules for non-invasive devices Rules for invasive devices Rules for active devices Special classification rules Rules for in vitro diagnostic (IVD) devices Guidance on classification

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.42. Medical Device Classification

1 hr

$495

Book now

$396

Available now

Background to medical device classification
Basics of classification in Australia
Rules for non-invasive devices
Rules for invasive devices
Rules for active devices
Special classification rules
Rules for in vitro diagnostic (IVD) devices
Guidance on classification

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

1.43. Interacting with the TGA for Medical Devices

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.43. Interacting with the TGA for Medical Devices	4o minutes	$330 Book now	$270 Available now	Responding to TGA requests Appealing TGA decisions Lodging annual reports Lodging incident reports and follow-up reports

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.43. Interacting with the TGA for Medical Devices

4o minutes

$330

Book now

$270

Available now

Responding to TGA requests
Appealing TGA decisions
Lodging annual reports
Lodging incident reports and follow-up reports

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU Agricultural and Veterinary

1.50. Overview of the Australian regulation of agricultural and veterinary chemicals

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
1.50. Agricultural and Veterinary Chemicals Including Complementary Animal Health Products such as Herbal and Nutraceutical Remedies	1 hr	$495 Book now	$396 Coming soon	APVMA Introduction Relevant legislation Agricultural chemicals Veterinary chemicals Active constituents Novel Products APVMA assessment process APVMA fees and charges Issues not covered by APVMA Excluded END products END product ingredients requirements END product labelling requirements END product manufacturing requirements APVMA FAQ APVMA Appendix APVMA Summary

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

1.50. Agricultural and Veterinary Chemicals Including Complementary Animal Health Products such as Herbal and Nutraceutical Remedies

1 hr

$495

Book now

$396

Coming soon

APVMA Introduction
Relevant legislation
Agricultural chemicals
Veterinary chemicals
Active constituents
Novel Products
APVMA assessment process
APVMA fees and charges
Issues not covered by APVMA
Excluded END products
END product ingredients requirements
END product labelling requirements
END product manufacturing requirements
APVMA FAQ
APVMA Appendix
APVMA Summary

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU & NZ Foods

2.01. Food Ingredients

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
2.01. Food Ingredients	2 hr	$990 Available now	Coming soon	Ingredient considerations in Australia and New Zealand Recent recalls due to ingredients Overview – Australian regulations for food ingredients FSANZ Food Standards Codes – relevant to ingredients Definitions and terms relating to ingredients Food vs medicine vs TGA Permissible foods in Australia Banned or prohibited ingredients Restricted contaminants Foods requiring pre-market clearance Novel Foods Food vs Ingredients Macro nutrients Micronutrients – vitamins & minerals Food additives Processing aids Specific food categories & ingredients Information requirements for ingredients Common issues Summary

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

2.01. Food Ingredients

2 hr

$990

Available now

Coming soon

Ingredient considerations in Australia and New Zealand
Recent recalls due to ingredients
Overview – Australian regulations for food ingredients
FSANZ Food Standards Codes – relevant to ingredients
Definitions and terms relating to ingredients
Food vs medicine vs TGA
Permissible foods in Australia
Banned or prohibited ingredients
Restricted contaminants
Foods requiring pre-market clearance
Novel Foods
Food vs Ingredients
Macro nutrients
Micronutrients – vitamins & minerals
Food additives
Processing aids
Specific food categories & ingredients
Information requirements for ingredients
Common issues
Summary

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

2.02. Food Labels

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
2.02. Food Labels	2 hr	$990 Book now	$792 Coming soon	Purpose of food labels Australian requirements for information on food products Common pitfalls and errors Components of a label Australia New Zealand Food Standards Code Part 1.2 Requirements to have a label or information Food identification Warning statements, declarations Statement of Ingredients Date marking Directions for use and storage Nutrition and health claims Nutrition Information Panels (NIP) Characterising ingredients Country of Origin Industry initiatives Label verification Label awareness – recall examples Labelling proposals

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

2.02. Food Labels

2 hr

$990

Book now

$792

Coming soon

Purpose of food labels
Australian requirements for information on food products
Common pitfalls and errors
Components of a label
Australia New Zealand Food Standards Code Part 1.2
Requirements to have a label or information
Food identification
Warning statements, declarations
Statement of Ingredients
Date marking
Directions for use and storage
Nutrition and health claims
Nutrition Information Panels (NIP)
Characterising ingredients
Country of Origin
Industry initiatives
Label verification
Label awareness – recall examples
Labelling proposals

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

2.03. Food Claims

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
2.03. Food Claims	1 hr	$495 Book now	$396 Coming soon	Purpose of claims Product information requirements overview Requirements for claims Product claims examples Enforcement of product claims Australia New Zealand Food Standards Code FSANZ food labelling requirements Nutrition, health and related claims Nutrition information requirements Other types of claims Common pitfalls and errors with claims FSANZ changes and proposals

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

2.03. Food Claims

1 hr

$495

Book now

$396

Coming soon

Purpose of claims
Product information requirements overview
Requirements for claims
Product claims examples
Enforcement of product claims
Australia New Zealand Food Standards Code
FSANZ food labelling requirements
Nutrition, health and related claims
Nutrition information requirements
Other types of claims
Common pitfalls and errors with claims
FSANZ changes and proposals

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

AU & NZ Advertising and Social Media

2.10. Advertising and Social Media in Australia and New Zealand

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
2.10. Advertising and Social Media in Australia and New Zealand	2.5 hrs	$1240 Book now	not available as pre-recorded course is constantly updated	This course is specifically designed for people involved in advertising in Australia and New Zealand. As well as covering general principles and social media “influencer” advertising, it includes issues specific to cosmetics, foods, complementary medicines and dietary supplements. It does not include information on labelling and regulatory submissions. This is not a marketing course. Government and other agencies What is an advertisement Green/environmental claims Natural claims Animal testing Country of origin claims ACCC social media advertising and selling guide New Zealand Fair Trading and consumer rights Social media Testimonials and endorsements Complaints Advertising cosmetics in Australia Advertising cosmetics in New Zealand Advertising foods in Australia and New Zealand Advertising sports supplements in Australia Advertising medicines in Australia Advertising dietary supplements in New Zealand

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

2.10. Advertising and Social Media in Australia and New Zealand

2.5 hrs

$1240

Book now

not available as pre-recorded

course is constantly updated

This course is specifically designed for people involved in advertising in Australia and New Zealand. As well as covering general principles and social media “influencer” advertising, it includes issues specific to cosmetics, foods, complementary medicines and dietary supplements. It does not include information on labelling and regulatory submissions. This is not a marketing course.

Government and other agencies
What is an advertisement
Green/environmental claims
Natural claims
Animal testing
Country of origin claims
ACCC social media advertising and selling guide
New Zealand Fair Trading and consumer rights
Social media
Testimonials and endorsements
Complaints
Advertising cosmetics in Australia
Advertising cosmetics in New Zealand
Advertising foods in Australia and New Zealand
Advertising sports supplements in Australia
Advertising medicines in Australia
Advertising dietary supplements in New Zealand

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

New Zealand

3.01. NZ Cosmetic Labelling and Claims

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
3.01. NZ Cosmetic Labelling and Claims	1 hr	$495 Book now	$396 Coming soon	New Zealand legislation. Ingredients Labelling Permitted claims Importation and self assessment

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

3.01. NZ Cosmetic Labelling and Claims

1 hr

$495

Book now

$396

Coming soon

New Zealand legislation.

Ingredients
Labelling
Permitted claims
Importation and self assessment

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

3.02. NZ Dietary Supplement Labelling and Claims

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
3.02. NZ Dietary Supplement Labelling and Claims	1 hr	$495 Book now	$396 Coming soon	Labelling and Claims Legislative framework Definitions Ingredients Manufacturing Labelling Claims Therapeutic Products Bill Update

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

3.02. NZ Dietary Supplement Labelling and Claims

1 hr

$495

Book now

$396

Coming soon

Labelling and Claims

Legislative framework
Definitions
Ingredients
Manufacturing
Labelling
Claims
Therapeutic Products Bill Update

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

3.10. NZ Pet food, animal feed, and nutritional supplements

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
3.10. NZ Pet food, animal feed, and nutritional supplements	1 hr	$495 Coming soon	$396 Coming soon	coming soon

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

3.10. NZ Pet food, animal feed, and nutritional supplements

1 hr

$495

Coming soon

$396

Coming soon

coming soon

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

Global

4.01. Compiling evidence to support claims for nutraceuticals and herbal medicines

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
4.01. Compiling evidence to support claims for nutraceuticals and herbal medicines	3 hr	AUD$1,495 Book now	AUD$1,196 Coming soon	Part 1 – Researching How to find evidence – literature searches How to find evidence – sources of evidence How to utilise electronic databases How to assess evidence – relevance How to assess evidence – quality How to assess evidence – balance Part 2 – Compiling an evidence package Overview Checklists General requirements (cover page) Evidence search strategy Evidence filters Evidence summaries Critical appraisals Justifications This course includes extensive resources and templates. Attendees receive a list of evidence sources and a user-friendly evidence package template. The course also includes hints, tips, examples and case studies

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

4.01. Compiling evidence to support claims for nutraceuticals and herbal medicines

3 hr

AUD$1,495

Book now

AUD$1,196

Coming soon

Part 1 – Researching

How to find evidence – literature searches
How to find evidence – sources of evidence
How to utilise electronic databases
How to assess evidence – relevance
How to assess evidence – quality
How to assess evidence – balance

Part 2 – Compiling an evidence package

Overview
Checklists
General requirements (cover page)
Evidence search strategy
Evidence filters
Evidence summaries
Critical appraisals
Justifications

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

4.02. New Product Development - Stage Gate Process

Course Name	Duration	Personal Tuition Course Cost*	e-Learning Course Cost*	Agenda
4.02. New Product Development – Stage Gate Process The templates provided with this course are specific to NPD for sponsors of listed complementary medicines. They would require minor amendments for products that fall under different regulatory classifications – e.g. dietary supplements or foods	1.5 hour	$1,800 Book now	$1,440 Coming soon	Part 1 – Foundations What is a stage gate process? Example stage gate process Potential gate decisions Why have a stage gate process? Who are the gatekeepers The innovation “funnel” Stage gate document system Part 2 – NPD Stages and Attachments Stage 1: Project brief Stage 2: Active formula Stage 3: Final formula Other resources and attachments: Capsule size capacity Branded ingredient supplier comparison Stage gate process map

Course Name

Duration

Personal Tuition Course Cost*

e-Learning Course Cost*

Agenda

4.02. New Product Development – Stage Gate Process

The templates provided with this course are specific to NPD for sponsors of listed complementary medicines. They would require minor amendments for products that fall under different regulatory classifications – e.g. dietary supplements or foods

1.5 hour

$1,800

Book now

$1,440

Coming soon

Part 1 – Foundations

What is a stage gate process?
Example stage gate process
Potential gate decisions
Why have a stage gate process?
Who are the gatekeepers
The innovation “funnel”
Stage gate document system

Part 2 – NPD Stages and Attachments

Stage 1: Project brief
Stage 2: Active formula
Stage 3: Final formula
Other resources and attachments:
Capsule size capacity
Branded ingredient supplier comparison
Stage gate process map

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

USA

5.01. US Dietary Supplements Ingredients and Labelling

Course Name	Duration	LIVE Course Cost*	e-Learning Course Cost*	Agenda
5.01. US Dietary Supplements Ingredients and Labeling	1 hr 20 min	unavailable	$750.00 Available now	Ingredient requirements Defining “Dietary Supplement” Allowable Dosage Forms Drug Exclusionary Clause New vs. Old Dietary Ingredients Labeling Required Labeling Elements Additional Labeling Considerations Misbranding California’s Proposition 65 Quality and Safety Adulteration Standard Good Manufacturing Practices (GMP) Requirements Inspections & Enforcement Adverse Event Reporting Food Safety Modernization Act (FSMA) FSMA Rules FSMA Enforcement Tools

Course Name

Duration

LIVE Course Cost*

e-Learning Course Cost*

Agenda

5.01. US Dietary Supplements Ingredients and Labeling

1 hr 20 min

unavailable

$750.00

Available now

Ingredient requirements

Defining “Dietary Supplement”
Allowable Dosage Forms
Drug Exclusionary Clause
New vs. Old Dietary Ingredients

Labeling

Required Labeling Elements
Additional Labeling Considerations
Misbranding
California’s Proposition 65

Quality and Safety

Adulteration Standard
Good Manufacturing Practices (GMP) Requirements
1. Inspections & Enforcement
Adverse Event Reporting
Food Safety Modernization Act (FSMA)
1. FSMA Rules
2. FSMA Enforcement Tools

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

5.02. US Dietary Supplement and Food Claims

Course Name	Duration	LIVE Course Cost*	e-Learning Course Cost*	Agenda
5.02. US Dietary Supplement and Food Claims	52 min	unavailable	$500.00 Available now	FDA regulation of food and dietary supplement claims Nutrient content claims Health claims Qualified Health Claims Structure/Function claims Disease vs Structure/FunctionClaim Enforcement Consumer class action lawsuits USDA Regulated claims Organic claims Bioengineered disclosure Animal raising claims FTC regulation of food and dietary supplement claims FTC regulation of claims FTC substantiation standard

Course Name

Duration

LIVE Course Cost*

e-Learning Course Cost*

Agenda

5.02. US Dietary Supplement and Food Claims

52 min

unavailable

$500.00

Available now

FDA regulation of food and dietary supplement claims

Nutrient content claims
Health claims
Qualified Health Claims
Structure/Function claims
Disease vs Structure/FunctionClaim
Enforcement
Consumer class action lawsuits

USDA Regulated claims

Organic claims
Bioengineered disclosure
Animal raising claims

FTC regulation of food and dietary supplement claims

FTC regulation of claims
FTC substantiation standard

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

5.03. US Overview of Advertising Regulations

Course Name	Duration	LIVE Course Cost*	e-Learning Course Cost*	Agenda
5.03. US Overview of Advertising Regulations	1 hr	unavailable	$500.00 Available now	Introduction Where do the rules come from? What is advertising in the USA? Who regulates advertising in the USA? Basics of Claim Substantiation FTC: General Advertising Principles Step 1: Identify claims that require substantiation Advertising and marketing fundamentals Puffery claims Step 2: Ensure the claims are supported What kinds of substantiation is a reasonable basis? What kinds of substantiation are NEVER a reasonable basis? Establishment claims Once substantiated is not always substantiated Disclosures Material information must be disclosed Must be clear and conspicuous 2012 “dot com” disclosure guides Updates coming Special Types of Advertising Claims – Health Claims FDA vs FTC FTC Health Products Compliance Guide Competent and reliable scientific evidence How to conduct a good study Weigh the totality of the evidence Study relevance Special Types of Advertising Claims – Made in USA Enforcement policies Standards Labelling rules Other laws and regulations Special Types of Advertising Claims – Green Claims Environmental marketing claims Green guides Testimonials Endorsements and Consumer Reviews FTC testimonial and endorsements guide Key requirements 2023 updates Disclosure of material connections Consumer review management

Course Name

Duration

LIVE Course Cost*

e-Learning Course Cost*

Agenda

5.03. US Overview of Advertising Regulations

1 hr

unavailable

$500.00

Available now

Introduction

Where do the rules come from?
What is advertising in the USA?
Who regulates advertising in the USA?

Basics of Claim Substantiation

FTC: General Advertising Principles
Step 1: Identify claims that require substantiation
Advertising and marketing fundamentals
Puffery claims
Step 2: Ensure the claims are supported
What kinds of substantiation is a reasonable basis?
What kinds of substantiation are NEVER a reasonable basis?
Establishment claims
Once substantiated is not always substantiated

Disclosures

Material information must be disclosed
Must be clear and conspicuous
2012 “dot com” disclosure guides
Updates coming

Special Types of Advertising Claims – Health Claims

FDA vs FTC
FTC Health Products Compliance Guide
Competent and reliable scientific evidence
How to conduct a good study
Weigh the totality of the evidence
Study relevance

Special Types of Advertising Claims – Made in USA

Enforcement policies
Standards
Labelling rules
Other laws and regulations

Special Types of Advertising Claims – Green Claims

Environmental marketing claims
Green guides

Testimonials Endorsements and Consumer Reviews

FTC testimonial and endorsements guide
Key requirements
2023 updates
Disclosure of material connections
Consumer review management

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

5.04. US Cosmetics - State Laws on Plastics, Recycling, Ingredients Bans, VOC and Producer Responsibility

Course Name	Duration	LIVE Course Cost*	e-Learning Course Cost*	Agenda
5.04. US Cosmetics – State Laws on Plastics, Recycling, Ingredients Bans, VOC and Producer Responsibility	1 hr	unavailable	$500.00 Available now	Plastics, recycling and extended producer responsibility Cosmetic ingredient bans and restrictions Cosmetic reporting requirements Special cosmetic labelling Do Not Flush wipes labelling VOC updates – California

Course Name

Duration

LIVE Course Cost*

e-Learning Course Cost*

Agenda

5.04. US Cosmetics – State Laws on Plastics, Recycling, Ingredients Bans, VOC and Producer Responsibility

1 hr

unavailable

$500.00

Available now

Plastics, recycling and extended producer responsibility
Cosmetic ingredient bans and restrictions
Cosmetic reporting requirements
Special cosmetic labelling
Do Not Flush wipes labelling
VOC updates – California

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

5.05. US Medical Devices - Is My Product an FDA-Regulated Medical Device?

Course Name	Duration	LIVE Course Cost*	e-Learning Course Cost*	Agenda
5.05. US Medical Devices – Is My Product an FDA-Regulated Medical Device?	40 min	unavailable	$500 Available now	Statutory definition of “device” Intended use Not all items affecting a body structure or function are regulated as devices Medical device classification Exclusions from the definition of “device” or active regulation by FDA Transition of laboratory-developed tests into active regulation

Course Name

Duration

LIVE Course Cost*

e-Learning Course Cost*

Agenda

5.05. US Medical Devices – Is My Product an FDA-Regulated Medical Device?

40 min

unavailable

$500

Available now

Statutory definition of “device”
Intended use
Not all items affecting a body structure or function are regulated as devices
Medical device classification
Exclusions from the definition of “device” or active regulation by FDA
Transition of laboratory-developed tests into active regulation

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

5.06. US Medical Devices - What FDA Requirements Apply to My Regulated Device?

Course Name	Duration	LIVE Course Cost*	e-Learning Course Cost*	Agenda
5.06. US Medical Devices – What FDA Requirements Apply to My Regulated Device?	1 hr 30 min	unavailable	$750 Available now	Medical device classification Class I devices Class II Devices Class III Devices De Novo Devices In Vitro Diagnostics Investigational Device Exemptions (Clinical Studies) Good Laboratory Practices Medical Device Tracking Postmarket Surveillance Recalls (Including Corrections and Removals) Overview of Medical Device Promotion and Marketing Considerations Import and Export of Devices

Course Name

Duration

LIVE Course Cost*

e-Learning Course Cost*

Agenda

5.06. US Medical Devices – What FDA Requirements Apply to My Regulated Device?

1 hr 30 min

unavailable

$750

Available now

Medical device classification
Class I devices
Class II Devices
Class III Devices
De Novo Devices
In Vitro Diagnostics
Investigational Device Exemptions (Clinical Studies)
Good Laboratory Practices
Medical Device Tracking
Postmarket Surveillance
Recalls (Including Corrections and Removals)
Overview of Medical Device Promotion and Marketing Considerations
Import and Export of Devices

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.

EU and UK

For online regulatory training courses on European Union / United Kingdom cosmetic, personal care regulations click on + for details

Go to Cosmetics Consultants Europe’s webpage https://www.ccecosmetic.org/cce-training-courses.

Bundle packages:

Get 10% off when you book 3 or more eLearning courses

Training Testimonials

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1 2 3 4 5 6 7 8

Testimonial 14

We recently completed the Pharmacovigilance Obligations course with Regulatory Training Direct and found it both informative and engaging. The course was structured in a clear and easy to follow way, making the complex topics we feared, accessible and enjoyable. We gained invaluable knowledge and now feel extremely confident in our understanding, ready to handle any potential Pharmacovigilance tasks. Highly recommend this course to anyone looking to deepen their expertise!

Luke Michael – THORZT

Testimonial 1

I would highly recommend this training to those would like to learn more about current pharmacovigilance requirements in the complementary medicine sector. The training was very useful and informative. After the training session I am more confident in the compliance of our pharmacovigilance procedures.

Adele

Testimonial 2

I recently had the pleasure of attending the RTD Pharmacovigilance Obligations course conducted by Quentin Blades. I found Quentin’s knowledge and experience in this space extremely valuable to my understanding of the required practices and systems that we need to have in place. The course enlightened me to new concepts and also reviewed and cemented previous knowledge, so it would be valuable for both new and more experienced regulatory personnel. I also found Quentin to be very warm and affable which helped to make what can be a broad and complex topic easy to break down and understand. I’m looking forward to further strengthening our already existing systems as a result of the course, knowing that in the event of an audit, we will have all mandatory requirements thoroughly covered.

Fiona

Testimonial 3

Thank you very much for the fantastic courses!
Attended three training courses from Regulatory Training Direct for cosmetic regulations for both Australia and New Zealand, covering from the fundamental legislative framework in each country to requirements for ingredients, labelling and claims etc. I was really impressed with the quality of those courses as they were quite systematic, in detail and informative, let alone the great presentations with lots of opportunities to ask questions for which answers/advice were given by the amazing presenters promptly during the presentation and afterwards with further explanations!

Manqi

Testimonial 4

Yesterday’s course (1.05 Specifications) exceeded my expectations. The content was comprehensive and I learned a lot. Quentin, as an excellent teacher and a master in his field, brought valuable insights and experiences through his personal anecdotes throughout the training. It was particularly valuable to learn from someone who has progressed naturally to become a teacher. I highly recommend the course!

Ricky

Testimonial 5

I recently completed the course offered by this business, and I must say that it was a fantastic experience. The course material was informative, engaging, and relevant to my needs. Bob, the instructor was knowledgeable and supportive throughout, and the course was delivered in a professional and well-organised manner. I highly recommend Regulatory Training Direct to anyone seeking to enhance their skills and knowledge in this area. Thank you for the wonderful learning experience!

Paul

Testimonial 6

Great live-training session with Bob who has a wealth of knowledge on regulatory affairs. The Introduction to Regulatory Affairs in Australia course delivers a very detailed overview of the regulatory framework for foods, cosmetics, and complementary medicines. The course notes are well presented and easy to navigate. I particularly like the useful links provided within the notes as this saves a lot of time tracking down relevant information. I highly recommend this course to anyone wanting to learn more. Thank you!

Louise O’Connor

Testimonial 7

We found the course very valuable and Bob was highly knowledgeable on all aspects and details of the regulatory information covered. We found the content and supplied reference links very helpful for our team and business & if offers great value to our clients for us to be on top of these regulations within both markets.

Maya Brown – Content & Co (NZ)

Testimonial 8

All of us in regulatory affairs are lifelong learners. Our profession requires it of us. However, I was surprised to find so few useful courses to get me up to speed on the differences between international regulations. RTD training did just that for me (someone coming from the USA) to learn about AUS and NZ regulations. Thank you for the time and consideration to thoroughly answer all my questions! I’ll certainly be back.

Anon

Testimonial 9

We recently completed five great live training modules with the team at Regulatory Training Direct. The course content was informative and well-presented, with practical examples and useful links to relevant regulatory documents and guidelines. The presenters were professional, knowledgeable, and accommodating. Collectively, they brought decades of experience to the training sessions, which they shared in an engaging and supportive manner. Module 2 – Evidence Packages was a standout module, and the enormous time and effort put into preparing this module was evident. The training has provided the team with the skills and knowledge required to navigate regulatory affairs, and we highly recommend this course!

Wendy McLean – Biomedica Nutraceuticals

Testimonial 10

I recently had the pleasure of attending Agricultural and Veterinary regulation training with Gary. Gary was able to provide me with a wealth of information and I learned about the different laws and regulations that apply to pet supplements, as well as the best practices for labelling and health claims on pet supplements. Gary was also very helpful in answering my questions and providing me with resources that I could use to learn more. Bob organised the training session and was very accommodating around times and last minute changes. I would highly recommend Regulatory Training Direct to anyone who is interested in learning more about pet supplement regulations.

Gabbie Watt – Naturopath & Nutrition Lead

Testimonial 11

Our team completed the course in Advertising and Social Media in Australia and New Zealand. Robert was very knowledgeable and we got a lot of value for the two hour course, as not only did we learn new things but he helped us to clarify a lot of existing questions that we had. Many of our clients are in the health and wellness space, specifically supplements so it is important for us to be up to date with regulations and compliance. We would definitely do another course with RTD in the future.

Annelise Clarke – Pink Digital

Testimonial 12

I was very impressed with the training from Regulatory Training Direct (RTD). The presentation was incredibly pragmatic, blending a clear understanding of legislative requirements with extensive industry insight to create a usable, applicable knowledge base in attendees. Our team left with a firm foundation from which to develop our own in-house processes. RTD even followed up to make sure the information we had received had met our initial requests, and did a short session to make up some small gaps we had at the end. Our presenters were also fun and easy going, making the learning experience fun. Highly recommended.

Rachel McDonald – AVS Nutrition

Testimonial 13

I recently completed the TGA Evidence Requirements Course offered by RTD and it exceeded my expectations in every way. The course content was thorough, up-to-date, and presented in a highly engaging and informative manner. Abbie is incredibly knowledgeable and made herself available to answer questions, providing real-world examples that made such a complex topic, easy to understand. While I already had a strong regulatory background, this course significantly enhanced my understanding of TGA evidence requirements. I would highly recommend this course to anyone looking to deepen their knowledge and expertise in TGA evidence requirements.

Anon – works in regulatory affairs

Testimonial 14

We recently attended a pharmacovigilance training session and was thoroughly impressed. The session was highly interactive, which made the complex material much more engaging and easier to understand. Mary, our instructor, was incredibly accommodating and attentive. Her expertise and approachable manner made for a highly effective and enjoyable learning experience. The CARSL NZ team can be certain our up-to-date QMS for PV is of the highest quality. Highly recommend!

David

Elevate your compliance capabilities with Regulatory Training Direct

Our courses have helped brands like these build their regulatory knowledge

Meet the Trainers

Abbie Harris

Director, Evidence, Claims & NPD Specialist

Abbie is a seasoned product developer, formulator and project manager. She has held management positions in small and large healthcare companies, leading product development teams to launch complementary medicines across many dosage forms, health categories, markets and regulatory systems.

In 2015 Abbie founded NPC, a consulting company specialising in the development and commercialisation of complementary medicines, foods and other healthcare products. NPC has nurtured an international client base, helping brands with all aspects of product development as well as regulatory affairs, training and technical writing.

Abbie is an active member of the industry. She attends leading international trade shows, education events and seminars and for several years contributed to the Regulatory Technical Committee within CMA – Australia’s peak industry body.

Robert Forbes

Director, Regulatory Specialist

Robert Forbes has been actively engaged in the Australian health and pharmaceutical industry since 1980, when he developed complementary medicines for practitioners. As the regulatory environment evolved he switched his focus to consulting on the new compliance obligations facing the industry.

Robert established Robert Forbes & Associates (RFA Regulatory Affairs), a regulatory consultancy providing advice for complementary medicines, foods, medical devices, cosmetics and household products. Robert has sat on committees and spoken at many industry conferences.

Until September 2016 Robert was the President of the Association of Therapeutic Goods Consultants (ATGC) in Australia, a position he stepped down from after 20 years’ service. In 2020 Robert received Lifetime Achievement award honours from the USA based Consultants Association for the Natural Products Industry.

Robert retired from regulatory consulting work at the end of June 2022 and is now focussed on publishing the monthly regulatory affairs newsletter Current Affairs and providing regulatory affairs training courses which have been developed over many years.

Gary Burgess

Medical device specialist

www.hillvalleyregulatory.com.au

Gary earned his Honours Degree in Biomedical Engineering from Flinders University, Adelaide, and after graduating spent several years in R&D roles.

Gary has been involved in the medical device regulatory affairs industry since 2005, including 9 years with the Australian Therapeutic Goods Administration (TGA) building his knowledge of the legislation, and leading teams responsible for the pre-market assessment of medical devices, as well as becoming an ISO13485 trained auditor.

Gary moved to the industry in 2014, where he held various roles and gained valuable experience at the Medical Technology Association of Australia (MTAA), Australian-based manufacturers of active implantable medical devices (Sirtex Medical and Cochlear Limited), and most recently as a consultant.

Gary is currently the Director and Principal Consultant at Hill Valley Regulatory Consulting, based in Canberra, Australia.

Outside of work, Gary enjoys reading, collecting Lego, learning to play the guitar, riding his mountain bike in the fresh air of Canberra, and playing board games with his three kids.

Mary Nteris

Pharmacovigilance and New Substances Specialist

www.enimeraregsplus.com.au

Mary founded Enimera RegsPlus in 2018 after 20+ years Regulatory experience in the Pharmaceutical/Clinical trials industry. She has held senior roles in biopharmaceutical, clinical research and wellness organisations, led teams and led strategic initiatives, having oversight of regulatory services in Australia, New Zealand and Asia.

She is a Life Member and former President of ARCS Australia, a guest-lecturer to a several post-graduate courses, and a mentor to post-graduate students through the IMNIS program. Mary holds a PhD in Pharmacology and is a Graduate of the Australian Institute of Company Directors.

Leanne McCauley

Australian medicines and medical devices advertising specialist

www.seeside.com.au

Leanne McCauley previously worked at the Therapeutic Goods Administration (TGA), where she garnered more than 9 years experience in the advertising code and advertising compliance. Leanne presents our course Advertising medicines and medical devices. This is a revision of a pre-existing course which focused on complementary medicines. The course now includes all non-prescription medicines and medical devices.

Leanne is the Principal of Seeside Advisory, a consultancy specialising in guiding advertisers of medicines and medical devices through the complexities of Australian advertising laws. Her work at the TGA included educating advertisers, developing guidance materials, and assisting with compliant advertising strategies. She played a pivotal role in shaping regulatory improvements, and collaborated with legal and policy teams, led stakeholder consultations, and managed the implementation of updated laws.

Growing up in her family’s pharmacy, Leanne developed a strong appreciation for the dedication required to run a small business and a deep understanding of consumer vulnerabilities. She draws on these experiences, along with her biochemistry degree, to help advertisers navigate regulatory challenges with confidence and compliance.

Leanne is a keen amateur photographer and family history enthusiast.

Michelle Cubitt

NZ Cosmetics and Dietary Supplement Specialist

https://www.smartreg.nz/

Michelle has over 15 years’ experience in the natural health and personal care industries where she has held a range of quality, regulatory and marketing roles. Michelle established her own regulatory consultancy agency Smart Regulatory Solutions in 2015. In her current role she provides advice and strategic input for businesses looking to access global export opportunities in food, natural health and personal care products. She assists New Zealand business with understanding regulatory requirements and the processes for launching export ready products.

Michelle is an active member of the natural product industries in New Zealand. She is an associate member of Cosmetics New Zealand and Board Member of Natural Health Products NZ, New Zealand’s leading natural products industry body.

Rita Sellars

https://www.phfactor.com.au/

AU Cosmetics Specialist

Rita is a recognised, accredited and world class Cosmetic Development Chemist. She is the development creator behind many exclusive brands. Her role allows her in assisting and implementing new products to the market either by developing the brand from the beginning to the end or help transition a product from an overseas portfolio to the Australian retail market, helping in formulating, brand management and taking their brands to market as well as vital industry assistance.

Working her way through the manufacturing and development, while studying, allowed Rita to build 17 years of a solid foundation in high end skincare. 25 years on, Rita founded pH Factor as she saw an area in the marketplace where customers wanted tailored products that performed.

Rita is a member of the Australian Society of Cosmetic Chemists and also Industry Natural and Organic Groups. Her personality and ability to connect with people provided strong foundations to teach what she loves. Rita has lectured at many industry events, and taught at various organisations especially to Beauty Therapists on the science of cosmetic ingredients.

Chinthani Wijayapala

Senior Regulatory Specialist

Chinthani has over 10 years’ experience within the Australian complementary medicines industry specialising in regulatory affairs, new product development, marketing and compliance. Having worked at leading manufacturers, brands and raw material suppliers, she has an array of knowledge ranging from initial formulation development to the compliant manufacturing of finished products.

Chinthani has provided consultancy services in regulatory affairs for numerous sectors, inclusive of complementary medicines, nutritional supplements, foods and cosmetics. Through her work in regulatory affairs and new product development, Chinthani has assisted numerous brands successfully bring products onto the Australian market, supporting them from innovation to new product launch.

Gary Kennedy

Food Specialist

http://www.correctfoodsystems.com.au/

Gary Kennedy graduated from the School of Food Technology, University of New South Wales in 1984. He has worked in the meat, transport and cook chill industries and within the healthcare sector; and as a food safety trainer, consultant and lead food safety auditor for nearly 40 years.

He has written near 50 papers, and has written or co-written guidelines and codes for the Cook-Chill, Smallgoods, Hospitals, Child Care and Refrigerated Transport Industries. He has trained some of Australia largest food companies on food safety and regulatory compliance.

He has a regular segment of “Afternoons” on ABC Radio Sydney and appears on programs on all four major television networks.

Lisa Owens

Food Specialist

http://www.correctfoodsystems.com.au/

Lisa is a specialist food safety trainer and consultant, working for Correct Food Systems and Correct Training Systems. She designs and delivers training and assessment relating to quality management systems, food safety auditing, HACCP systems, and has assisted many food service, manufacturers and health care businesses manage their compliance systems and requirements. She also is a National Food Safety Auditor ( High Risk) and regularly conducts HACCP certification audits, and compliance inspections. Lisa has up to date knowledge of the standards that apply across the range of food industry sectors, and local jurisdictions and assists clients to address these requirements. Major government and private companies in the health sector have engaged her training services.

Rend Al-Mondhiry

US dietary supplement and food law specialist

www.awglaw.com

Rend Al-Mondhiry is a Partner at Amin Talati Wasserman LLP in Washington, DC. She advises clients in the dietary supplement, food, and cosmetic industries on a broad range of FDA and FTC compliance matters, with a focus on helping companies navigate the rapidly evolving regulatory landscape for hemp and CBD products at both the federal and state level. She is committed to helping her clients responsibly develop and market products, drawing on her years of experience advising the nation’s leading dietary supplement and food companies on complex labeling, advertising, and ingredient issues. In her previous role as Associate General Counsel at the Council for Responsible Nutrition, Rend advocated on the industry’s behalf numerous times before FDA, FTC, Congress, and state attorneys general. She has assisted companies with FDA import alerts and detentions, International Trade Commission matters, and Proposition 65 compliance, and has substantial experience initiating and defending challenges before the Council of Better Business Bureau’s National Advertising Division.

She is also a frequent speaker and author on emerging legal and regulatory issues in the industry and is regularly quoted in the trade press. In addition, since 2017 Rend has served as a guest lecturer at Georgetown University Law Center on the topic of dietary supplement regulation.

Lauren Aronson

US advertising law specialist

www.awglaw.com

Lauren Aronson is a leading advertising and marketing lawyer, and partner in award winning law firm Amin Wasserman Gurnani. Lauren initiates and defends false advertising challenges before the National Advertising Division and Direct Selling Self-Regulatory Council and represents clients in false advertising litigation. Lauren also handles regulatory defence matters relating to marketing and sales practices brought by the Federal Trade Commission and state attorneys general. products range from food, cosmetics and dietary supplements to household products. She also advises on social media advertising, testimonials and endorsements, and consumer reviews. She has received many accolades for her services.

Lauren enjoys travelling with her family, trying new restaurants, musical theatre, and reading.

Angela Diesch

US cosmetics law specialist

www.awglaw.com

Angela Diesch heads the Cosmetics Industry practice at Amin Wasserman Gurnani. With a unique focus on the “natural” and “organic” sectors of consumer products, she advises clients at all stages of product development, including determining correct product classification and whether premarket notifications are needed. She reviews product labels and marketing to ensure compliance with applicable laws and regulations and assesses claims for adequate substantiation. Angela advises clients on developing SOPs and compliance with applicable cGMP and quality control requirements.

Angela is also a seasoned litigator who helps clients resolve enforcement actions and investigations initiated by the FDA, FTC, NAD, states’ attorneys general and district attorneys. Angela is the Chair of NSF International’s Joint Committees on Organic Personal Care (NSF/ANSI 305), Good Manufacturing Practices for Cosmetics and OTC Drugs (NSF/ANSI 455-3 & 455-4). Angela routinely speaks at industry conferences and seminars, and conducts educational training programs.

Outside of law, Angela is an avid skier who also enjoys camping, mountain biking and paddle boarding on the alpine lakes near her home.

Neil O’Flaherty

US medical device specialist

www.awglaw.com

Neil O’Flaherty has over 34 years of legal experience representing medical device clients regulated by the U.S. Food and Drug Administration (FDA). He is the head of the Medical Device Practice Group at Amin Wasserman Gurnani LLP

Neil is an advocate for his clients when they face compliance, enforcement, and other obstacles with FDA. Neil assists clients with Class I, II, or III medical devices at any stage in their product’s premarket and commercial lifecycle. He also assists clients with combination products and human cells, tissues, and cellular and tissue-based products (HCT/Ps), as well as with FDA requirements applicable to medical and non-medical radiation-emitting electronic products.

Neil is a regular speaker and author on FDA medical device topics and has presented on FDA issues in Canada, Japan, the United Kingdom, France, Germany, Switzerland, and the United Arab Emirates.

Outside the office, Neil enjoys spending time with his wife Regina and daughter Reilly (probably watching too much Netflix with them). He is an avid fan of Notre Dame sports and the Chicago White Sox. You can also often find Neil walking along the banks of Lake Michigan or the Chicago River.

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Course Summary

Australia

AU Complementary Medicines

AU and NZ Pharmacovigilance

AU Recalls

AU Advertising

AU GMP Clearance of Overseas Manufacturers

AU Cosmetics

AU Sports Supplements

AU Sunscreens

AU Medical Devices

AU Agricultural and Veterinary

AU & NZ Foods

AU & NZ Advertising and Social Media

New Zealand

Global

USA

EU and UK

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Meet the Trainers

Abbie Harris

Robert Forbes

Gary Burgess

Mary Nteris

Leanne McCauley

Michelle Cubitt

Rita Sellars

Chinthani Wijayapala

Gary Kennedy

Lisa Owens

Rend Al-Mondhiry

Lauren Aronson

Angela Diesch

Neil O’Flaherty

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