Your training partner for regulatory affairs

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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.

We are a member of the Association of Therapeutic Goods Consultants Inc.

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:

  1. Live training personal tuition sessions with an expert presenter conducted via Zoom. This option allows for Q&A and a more interactive experience.
  2. 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

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Course Description
1.01.  Introduction to Regulatory Affairs in Australia 1 hr $495

Book now
 $396

Available now
 Listed medicines, medical devices, foods, cosmetics

  • 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU Complementary Medicines

Course Name Duration Personal Tuition Course Cost*  eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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:

  1. Supplier raw material specification: ascorbic acid
  2. Manufacturer starting material specification: ascorbic acid
  3. Sponsor finished product specifications: Stress + Fatigue
  4. BP Monograph: ascorbic acid
  5. and 5a: EP Uniformity of mass
  6. Compositional monograph: Rhodiola rosea
  7. FPS template for hard capsule
  8. FPS template for oral powder
  9. FPS template for chewable tablets
  10. FPS template for dispersible tablets
  11. FPS template for enteric coated hard capsules
  12. FPS template for enteric coated soft capsules
  13. FPS template for enteric coated tablets
  14. FPS template for sustained and modified release tablets
  15. FPS template for topical liquids

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personl Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.09. Preparing and submitting a listed medicine application 2.5 hr $1237.50

Book now
 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
  • 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.11. Herbal Fundamentals 1 hr $495.00

Book now
 Coming soon This course is for people who are new to herbal medicines and need to know more about the regulatory requirements for manufacturing and inclusion in a finished product.

  • What is a herb
  • Herbal medicine history
  • Nomenclature
  • Plant parts
  • Plant preparations
  • Extract ratios
  • Solvents
  • Carriers and excipients
  • Standardisation
  • Monographs
  • Adulteration and contamination
  • Supplier qualification
  • Raw material specifications
  • The manufacturer’s starting material specifications
  • The sponsor’s finished product specifications
  • Stating herbal ingredients on a product label
  • Supporting indications for use
  • Other helpful courses

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.12. Compliance Obligations for Listed Complementary Medicines 3 hours $1,500

Book now
 $1,200

Available now
 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.13. GMP mentoring 1 hour per module

Can be conducted as a one-off session, or multiple or regular sesions can be arranged.

 $495.00 per hour.

Will be invoiced when your session is booked.

 not available A mentoring programme for quality and technical staff working with GMP compliance who wish to discuss topics face to face via Zoom with an experienced GMP specialist. Course is conducted by appointment.

Forward your topics in advance. Some examples of topics:

  • Method validation
  • Stability testing
  • Release-for-supply
  • Product quality reviews
  • Quality risk management

And there are many more you may need to discuss.

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.14. GMP Fundamentals 1 hr $495

Book now
 not available This is an introductory course to GMP and how, in Australia, the PIC/S Guide to Good Manufacturing Practice for medicinal products is applied to complementary medicines (“dietary supplements” in other countries)

  • What is GMP
  • What is Australia’s code of GMP
  • Different types of GMP
  • What products in Australia need to comply with GMP
  • Complementary medicines GMP
  • Steps in manufacture
  • Finished product specifications (FPS)
  • Manufacturers outside of Australia
  • GMP Inspections
  • After a GMP inspection
  • GMP Contract Agreements

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU and NZ Pharmacovigilance

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.15. Pharmacovigilance obligations 2 hr $2,200

Book now
 $1,760

Coming soon
  • References
  • What is pharmacovigilance
  • Pharmacovigilance terminology
  • Responsibilities for pharmacovigilance activities
  • What needs to be reported
  • Reporting timeframes
  • How to report
  • Record keeping requirements
  • Pharmacovigilance system
  • Quality Management System
  • TGA PV Inspection programme
  • Training
  • Agreements
  • Summary of attachments provided
  • Includes full set of 18 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU Recalls

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.16. Product recalls – medicines, medical devices, foods, cosmetics Coming soon 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU Advertising

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.17. Advertising medicines and medical devices

to consumers in Australia

 2.5 hour $1,240

Book now
 $992

2 hr 10 min

Available now
  • 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU GMP Clearance of Overseas Manufacturers

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.18. GMP clearance of overseas manufacturers Coming soon 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU Cosmetics

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU Sports Supplements

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU Sunscreens

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.40. Sunscreens– medicine or cosmetic? 1.5 hr $742.50

Book now
 $594

Coming soon
  • Regulatory categories of sunscreens
  • Sunscreens regulated by the TGA as medicines
  • Permitted ingredients
  • Recent developments with 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

Course Name Duration Personal Tuition Course Cost* eLearning 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
  • Suply of unapproved devices
  • Advertising medical devices
  • Update on regulatory reforms for medical devices

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU Pet supplements

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
1.50. Pet supplements

This course replaces previous course 1.50. Agricultural and Veterinary Chemicals

 1 hr $495

coming soon

 $396 The agenda will focus on pet supplements

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU & NZ Foods

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

AU & NZ Advertising and Social Media

Course Name Duration Personal Tuition Course Cost* eLearning 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, therapeutic products and dietary supplements.

Therapeutic products: this is specific to Australia, and includes complementary and non-prescription medicines and medical devices.

This course 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 and influencers
  • 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 therapeutic products 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

New Zealand

Course Name Duration Personal Tuition Course Cost* eLearning Course Cost* Agenda
3.01. NZ Cosmetic Labelling and Claims 1 hr $495

Book now
 $396

Available now
 New Zealand legislation.

  • Definitions
  • Product inclusions / exclusions
  • Ingredients
  • Labelling
  • Claims
  • SDS
  • Record of assignment (importation and self assessment)

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Global

Course Name Duration Personal Tuition Course Cost* eLearning 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

*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

Course Name Duration Personal Tuition Course Cost* eLearning 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. *This is not legal advice, seek advice from your legal counsel if you need a legal opinion on the content of the course.

USA

Course Name Duration LIVE Course Cost* eLearning 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.

Course Name Duration LIVE Course Cost* eLearning 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.

Course Name Duration LIVE Course Cost* eLearning 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.

Course Name Duration LIVE Course Cost* eLearning 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.

Course Name Duration LIVE Course Cost* eLearning 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.

Course Name Duration LIVE Course Cost* eLearning 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

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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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

Testimonial 15


(listed medicines labels): The course was exactly what I was hoping for, informative, well-structured and Chinthani was an excellent facilitator, answering all my questions.

Mairead – Regulatory & Quality Associate

Testimonial 16

(Sunscreens – medicine or cosmetic?):  TGA Regulatory Training with the legendary Robert Forbes (Regulatory Training Direct) – learning the toughest language of all: regulation.

Melitta Adam – Founder and CEO Melitta Skin

Testimonial 17

We recently completed the ‘TGA evidence requirements for claims’ training module with Abbie. As we are just starting our journey into this field, we found the material provided extremely useful. The course content was highly informative and with several examples to facilitate understanding of the subject. The trainer was both very knowledgeable, engaging, and professional and always available to answer all our questions. We highly recommend this course to anyone who’s venturing into evidence package building or wants to stay current with their knowledge and understanding of the regulations.

Anonymous Pharma Company

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 the Technical Director 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 Wasserman Gurnani 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.

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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