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, 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.
Who is the training for?
Sponsors, brand marketers, contract manufacturers, established brands, new-comers, 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.
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 sessions with an expert presenter conducted via zoom. This option allows for Q&A and a more interactive team experience.
- Recorded training modules delivered by our expert presenters through our e-learning platform. This option includes live recording on demand and can be completed at your own pace.
NOTE: e-learning courses are not yet available. Coming in 2023.
What do I get?
LIVE Training | e-Learning Training (Coming in 2023) |
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Course Summary
Click on title to view agenda and pricing.
Australia
1.01. Introduction to Regulatory Affairs in Australia - listed medicines, foods, cosmetics
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Course Description |
1.01. Introduction to Regulatory Affairs in Australia – listed medicines, foods, cosmetics | 1 hr | $495 Available now | $396 Coming soon |
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*10% GST is added if we are billing an Australian company
AU Complementary Medicines
1.02. Evidence Packages
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.02. Evidence Packages | 3 hr | $1,495 Available now | $1,196 Coming soon | Part 1 – Foundations
Part 2 – Researching
Part 3 – Compiling an evidence package
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
1.03. Listed medicine labels
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.03. Listed medicine labels | 1.5 hr | $742.50 Available now | $594 Coming soon |
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*10% GST is added if we are billing an Australian company
1.04. Product Advertising
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.04. Product Advertising | 1.5 hr | $742.5 Available now | $594 Coming soon | Complying with the Therapeutic Goods Advertising Code.
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*10% GST is added if we are billing an Australian company
1.05 Specifications
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Course Description |
1.05 Specifications | 2 hr | $990 Available now | $792 Coming soon | The Supplier’s Raw Material Specification This comes from the supplier of the ingredient to be used in manufacture;
The Manufacturer’s Starting Material Specification Developed by the product manufacturer in accordance with GMP
The Sponsor’s Finished Product Specifications (FPS) The sponsor’s description of the finished packaged product
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*10% GST is added if we are billing an Australian company
1.06. Stability testing
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.06. Stability testing | 1.5 hr | $742.50 Available now | $594 Coming soon | Who, what, when of stability testing
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*10% GST is added if we are billing an Australian company
1.07. Product Quality Reviews
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.07. Product Quality Reviews | 1 hr | $495 Coming soon | $396 Coming soon | An overview of Product Quality Reviews – now a mandatory GMP requirement.
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*10% GST is added if we are billing an Australian company
1.08. GMP agreements
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.08. GMP agreements | 1 hr | $495 Available now | $396 Coming soon | An overview on this mandatory agreement between product sponsor and all manufacturers involved in production.
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*10% GST is added if we are billing an Australian company
1.09. Preparing and submitting a listed medicine application
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.09. Preparing and submitting a listed medicine application | 1.5 hr | $742 Available now | $594 Coming soon |
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*10% GST is added if we are billing an Australian company
1.10. New substance applications
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.10. New substance applications | 1.5 hr | $742 Available now | $594 Coming soon | Part 1 The TGA regulatory framework
Part 2 Quality
Part 3 Safety
Part 4 Important considerations
Part 5 Useful links Part 6 Resources |
*10% GST is added if we are billing an Australian company
AU Pharmacovigilance
1.15. Pharmacovigilance obligations
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.15. Pharmacovigilance obligations | 1.5 hr | $2,200 includes full set of 10 documents and procedures Available now | $1,760 Coming soon |
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*10% GST is added if we are billing an Australian company
AU Cosmetics
1.20. AU Cosmetic Claims and Labelling
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.20. AU Cosmetic Claims and Labelling | 2 hrs | $990 Available now | $792 Coming soon | Regulatory framework
Cosmetic claims
Cosmetic labels
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*10% GST is added if we are billing an Australian company
1.21. AICIS Cosmetic Ingredient Introductions
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.21. AICIS Cosmetic Ingredient Introductions | TBC | TBC | TBC | Part 1 – Overview
Parts 2 – 5 Coming soon |
*10% GST is added if we are billing an Australian company
AU Sports Supplements
1.30. AU Sports Supplements - medicine or food?
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.30. AU Sports Supplements – medicine or food? | 1 hr | $495 Available now | $396 Coming soon |
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*10% GST is added if we are billing an Australian company
AU Sunscreens
1.40. Sunscreens– medicine or cosmetic?
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
1.40. Sunscreens– medicine or cosmetic? | 1 hr | $495 Available now | $396 Coming soon |
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*10% GST is added if we are billing an Australian company
AU Agricultural and Veterinary
1.50. Overview of the Australian regulation of agricultural and veterinary chemicals
Course Name | Duration | LIVE 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 Available now | $396 Coming soon |
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*10% GST is added if we are billing an Australian company
AU & NZ Foods
2.01. Ingredients
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
2.01. Food Ingredients | 1 hr | $495 Coming soon | $396 Coming soon | TBC |
*10% GST is added if we are billing an Australian company
2.02. Food Labels
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
2.02. Food Labels | 2 hr | $990 Available now | $792 Coming soon |
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*10% GST is added if we are billing an Australian company
2.03. Food Claims
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
2.03. Food Claims | 1 hr | $495 Available now | $396 Coming soon |
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*10% GST is added if we are billing an Australian company
AU & NZ Advertising
2.10 Advertising and Social Media in Australia and New Zealand
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
2.10 Advertising and Social Media in Australia and New Zealand | 2 hrs | $990 Available now | $792 Coming soon | 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.
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*10% GST is added if we are billing an Australian company
New Zealand
3.01. NZ Cosmetic Labelling and Claims
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
3.01. NZ Cosmetic Labelling and Claims | 1 hr | $495 Available now | $396 Coming soon | New Zealand legislation.
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*10% GST is added if we are billing an Australian company
3.02 NZ Dietary Supplement Labelling and Claims
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
3.02 NZ Dietary Supplement Labelling and Claims | 1 hr | $495 Available now | $396 Coming soon | Labelling and Claims
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*10% GST is added if we are billing an Australian company
3.10 NZ Pet food, animal feed, and nutritional supplements
Course Name | Duration | LIVE 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
Global
4.01. Compiling evidence to support claims for nutraceuticals and herbal medicines
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
4.01. Compiling evidence to support claims for nutraceuticals and herbal medicines | 3 hr | AUD$1,495 | AUD$1,196 | Part 1 – Researching
Part 2 – Compiling an evidence package
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
4.02. New Product Development - Stage Gate Process
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
4.02. New Product Development – Stage Gate Process | 1.5 hour | $1,800 Available now | $1,440 Coming soon | Part 1 – Foundations
Part 2 – Stage Gate Document Stream
This course comes with a set of eight templates and forms |
*10% GST is added if we are billing an Australian company
USA
5.01 Dietary supplements
Course Name | Duration | LIVE Course Cost* | e-Learning Course Cost* | Agenda |
5.01 Dietary supplements | 1 hr 20 min | unavailable | $1,000.00 | Ingredient requirements
Labeling
Quality and Safety
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*10% GST is added if we are billing an Australian company
Bundle packages:
Get 10% off when you book 3 or more courses
Elevate your compliance capabilities with Regulatory Training Direct
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Meet the Trainers
Abbie Harris
Director, Evidence, Claims & NPD Specialist
Abbie is a veteran 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 holds a position on 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.
Sue Pereira
Pharmacovigilance consultant
Sue is a medically qualified healthcare professional, with postgraduate qualifications in pharmacology and clinical research.
She is a pharmacovigilance professional with 9 years’ experience in the pharmaceutical industry, having worked for pharmaceutical consultancies, big pharmaceutical and biotech companies. She is also well versed with patient support programs. She has been the Qualified Person for Pharmacovigilance in Australia (QPPVA) both for local pharma companies and for consultancy clients. She has led the gap analysis in pharmacovigilance and has experience with pharmacovigilance audits and inspections.
Sue also has experience in managing deviations and CAPA (Corrective Action Preventive Action) in pharmacovigilance. She has conducted pharmacovigilance training for both internal and external stakeholders in the pharmaceutical industry. Medical assessment of individual case study reports and assigning company causality is another area of her expertise.
Michelle Cubitt
NZ Cosmetics and Dietary Supplement Specialist
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
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.
Melinda Tizzone
AU Cosmetics Business and Education Manager
Manufacturing and Production Specialist has over 20 years of combined skills in retail, marketing, manufacturing, and education in the Beauty and Wellness space.
As a qualified educator, with a Bachelor of Education and Cert IV in training and assessment Melinda provides expert advice and strategies to advise you on how to bring your product market; everything from compliance, ingredient choice, formulation suggestions and marketing.
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
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
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
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.