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.
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.
- Companies wanting to export into new markets.
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.
What do I get?
Live Training (personal tuition) | e-Learning Training |
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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, 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 | $396 |
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*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 | $1,560 | 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. 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 | $396.00 Coming soon |
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*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.
1.04. Product Advertising
Course Name | Duration | Personl Tuition Course Cost* | e-Learning Course Cost* | Agenda |
1.04. Product Advertising | 1.5 hr | $742.5 | $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. 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 | $990 | $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. 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 | $594 Coming soon |
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*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 | $396 Coming soon | An overview of Product Quality Reviews – mandatory GMP requirement.
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*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 | $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. 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 | $594 Coming soon |
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*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 | $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. Prices quoted are in Australian dollars.
AU 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 | $1,760 Coming soon |
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*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 | $792 Coming soon | Regulatory framework
Cosmetic claims
Cosmetic labels
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*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 | $396 Coming soon |
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*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 | $396 Coming soon |
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*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 | $396 Coming soon |
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*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 | Coming soon |
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*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 | $792 Coming soon |
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*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 | $396 Coming soon |
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*10% GST is added if we are billing an Australian company. Prices quoted are in Australian dollars.
AU & NZ Advertising
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 hrs | $990 | $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. 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 | $396 Coming soon | New Zealand legislation.
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*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 | $396 Coming soon | Labelling and Claims
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*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 |
*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 | AUD$1,196 Coming soon | 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. 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 | $1,440 Coming soon | Part 1 – Foundations
Part 2 – NPD Stages and Attachments
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*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 | Ingredient requirements
Labeling
Quality and Safety
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*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 | 1 hr | unavailable | $500.00 | FDA regulation of food and dietary supplement claims
USDA Regulated claims
FTC regulation of food and dietary supplement claims
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*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 | Introduction
Basics of Claim Substantiation
Disclosures
Special Types of Advertising Claims – Health Claims
Special Types of Advertising Claims – Made in USA
Special Types of Advertising Claims – Green Claims
Testimonials Endorsements and Consumer Reviews
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*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 |
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*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? | 1 hour | unavailable | Coming soon |
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*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? | 2 hours | unavailable | Coming soon |
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*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 courses
Elevate your compliance capabilities with Regulatory Training Direct
Our courses have helped brands like these build their regulatory knowledge
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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.
Quentin Blades
Pharmacovigilance Specialist
From 1977 until 1997 Quentin managed the Quality Assurance departments of a number of leading pharmaceutical, complementary medicine, medical device and cosmetic companies. This involved regulatory affairs functions, manufacturing and production processes, product development, and technical training.
Quentin established Quality Assurance systems and procedures for Australia’s leading Medical Device Company – Cook Australia, and Australia’s leading Health Supplement Company – Blackmores. He has developed and implemented GMP training programs for laboratory and production staff, introduced sophisticated analytical technology, created effective quality management system documentation, and introduced the first computerised product stability monitoring program for Blackmores health products.
Quentin has assisted manufacturers in Australia, USA, Japan, China and Taiwan in meeting the requirements of Australia’s TGA GMP Code and preparing for ISO certification.
Quentin holds a Master of Medical Science in Drug Development degree (with high distinction) from the University of New South Wales. Quentin was one of the first students to enrol in the course and also served on the University Board of Studies.
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.
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.
Andrew Lattimore
GMP Specialist
Andrew served in various quality control and quality assurance roles from 1988 to 1995. In 1995 Andrew was appointed as a GMP auditor by the Australian National Registration Authority (now the Australian Pesticides and Veterinary Medicines Authority) and conducted GMP audits of veterinary medicines manufacturers and contributed to development of the Authority’s operating procedures.
In 1996-1997 Andrew was employed by the Australian Red Cross Blood Service as Quality Assurance Officer primarily to coordinate the NSW Blood Bank internal GMP Audit programme and conduct GMP audits of Blood Bank centres across NSW.
For 14 years from 1997 – 2011 he was a GMP Inspector and Quality Systems auditor with the Australian Therapeutic Goods Administration (TGA). He conducted inspections and audits of a broad range of manufacturers of therapeutic goods including Sterile and Non-sterile Medicines, Vaccines, Biologicals, Complementary Medicines, and Active Pharmaceutical Ingredients; and Sterile and Non-sterile Medical Devices and In-Vitro Diagnostic kits; both in Australia and internationally. Andrew was also engaged by the World Health Organisation under short-term contracts by the WHO Essential Medicines and Health Products programme as a GMP inspector in 2013-2017.
Andrew now runs his own consultancy, conducting audits of manufacturers and API suppliers; supporting clients undergoing regulatory inspections by the TGA and other PIC/S member agencies; preparing and reviewing pharmaceutical quality systems documentation.
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
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.