Videos

Regulatory Framework for Drug Establishment Licenses (DEL) in Canada & Medical Importation to Australia

Sit down with Marie Sweeney of Cannabis License Experts and learn how to navigate regulatory framework for drug establishment licenses (DEL) and medicinal importation to Australia. We'll start with an introduction to, followed by the importation of, medicinal cannabis into Australia. We'll then take a deep dive into Drug Establishment Licenses (DEL) in Canada including types of DELs, licensing fees, and the application process with all of its ins and outs.

Everything you need to know about Health Canada, NHPs Regulations and Exporting NHPs to Canada

Canada’s NHP sector generates over $5.5 billion in sales, according to Alive Magazine, June 19, 2023. More than 71% of Canadians consume natural health products with the sector continuing to see year over year growth. As well, the NHP regulations have become one of the most well respected regulatory framework in the world. However, the regulations are very complex and have multiple requirements in order to register and export NHPs to the Canadian market. ChemLinked partnered with Andrew Parshad and Quality Smart Solutions to provide a comprehensive guide on understanding Health Canada’s regulations for natural health products and considerations when registering and exporting NHPs to Canada.

Structure Functions Explained: Structure Function Claims Regulatory Guidance, FDA Regulations

In this video, we delve into the fascinating world of structure functions and explore the regulatory guidance surrounding structure functions claims. Join us as we navigate through the FDA regulations that govern these claims, providing you with a comprehensive understanding of this important topic. Discover the intricacies of structure functions and how they impact various sectors, including dietary supplements, foods, veterinary health products, medical devices, pharmaceuticals, and even cannabis-related products. Our goal is to equip you with the knowledge you need to make informed decisions about your health and well-being.

How to get your Food Handlers License? Essential Guidelines for Food Handlers in 2023

In this comprehensive guide, we'll walk you through the process of obtaining your food handlers license step-by-step. We'll discuss the requirements, training programs, and certifications needed to meet food safety regulations. Additionally, we'll cover important topics such as food hygiene, handling practices, and safety procedures that every food handler should be familiar with.

How to get HACCP Certified: An overview of the HACCP Process, HACCP Certification Compliance

Join us as we explore the key concepts of HACCP food safety, including critical control points, certificate requirements, and the role of HACCP consultants. We also highlight the convenience and flexibility of online HACCP certification programs, making it accessible to individuals seeking to enhance their knowledge and skills in food safety. By implementing a HACCP-based food safety management system, businesses can mitigate risks, prevent foodborne illnesses, and comply with industry standards. Learn about the essential components of HACCP regulatory compliance and its significance in maintaining a safe and reliable food supply chain.

5 Steps to Navigating Regulatory Requirements for Samd: Software as a Medical Device (Samd)

Food Labelling Health Canada Packaging Updates These new changes represent a significant cost investment for specific businesses operating in various food product segments specifically targeted by the regulations. The food industry has been given until January 1, 2026, to make this change. However, you may start seeing the front-of-package nutrition symbol earlier. We'll have regulatory, engineering, product development, and a distributor share their expertise in a presentation and interactive panel format so you can ask them questions about succeeding in our industry.

FSVP Certification: Understanding FSVP Requirements for Importing Food Products

FSVP Certification, an integral part of the Foreign Supplier Verification Program (FSVP), ensures that imported food meets the stringent standards of safety and quality set by the FDA. We provide valuable insights into the FSVP requirements, including supplier verification, corrective actions, and compliance with FDA regulations and safety standards. As importers, understanding the FSVP certification process is crucial to safeguard public health and maintain the integrity of the food supply chain. Our expert team at Quality Smart Solutions breaks down the key steps involved, including obtaining FDA certification for import and meeting US food import requirements. We also discuss the significance of having a valid US food imports license.

Drug Identification Number (DIN) Explained: What You Need to Know, Importance and Regulations

Discover why drug identification numbers are crucial for the healthcare industry and how they contribute to patient safety. Gain insights into the specific requirements and guidelines set forth by Health Canada for obtaining a DIN. We'll explore the benefits of adhering to these regulations and the consequences of non-compliance..

Medical Devices in Canada MDEL and MDL: Medical Device Manufacturing and Classification in 2023

Gain a comprehensive understanding of medical device regulations, classification criteria, and the Canadian healthcare system's impact on the industry. We'll discuss how medical devices are classified in Canada, offering practical guidance for manufacturers and sharing key insights for healthcare professionals. Discover the ins and outs of obtaining a medical device class and license, ensuring compliance with regulations while navigating the dynamic medical devices industry in Canada. Stay up to date with the latest trends, opportunities, and challenges in medical device manufacturing in 2023.

Safe Foods for Canadians Regulations (SFCR License): Understanding Food Safety Regulations

Discover the key aspects of food safety regulation in Canada, including preventive control measures and compliance requirements. We shed light on the Safe Foods for Canadians Regulations, offering valuable insights into the regulations and their impact on food safety and quality assurance in Canada.

FDA FURLS: How Do They Affect Medical Device Manufacturers? FDA FURLS Process in Canada

Learn about the FDA regulations for medical devices and gain insights into the FDA approval process. We discuss the importance of complying with FDA regulations to ensure the safety and effectiveness of medical devices. Discover how FDA FURLS affects medical device manufacturers, including the process and requirements involved.

Health Canada Front of Package (FOP Labeling) Regulatory Session

Everything You Should Know About FDA GRAS Status

Have you ever wondered what it means for a food or ingredient to be 'Generally Regarded as Safe' (GRAS)? This video will explain what GRAS is and how to obtain it from the U.S. Food and Drug Administration (FDA) so you can stay updated on the latest FDA regulations.

11 Ways MOCRA will enhance FDA Cosmetics Regulations in 2023

11 ways MoCRA will enhance FDA Cosmetics Regulations: 1. Cosmetic Product Listing 2. Registration of Cosmetic Facilities and Renewal 3. Cosmetic Good Manufacturing Practices (GMP) 4. Adverse Event Report 5. New Cosmetic Labeling Requirements 6. FDA Additional Powers 7. Cosmetic Records Inspection 8. Cosmetic Mandatory Recall 9. Record of Cosmetic Adverse Reports 10. Small Business Exemptions 11. Cosmetic Safety Substantiation

What is an Importer of Record & How does it Impacts your business?

For businesses that trade goods internationally, the Importer of Record (IOR) is a crucial figure for making sure important customs and tax regulations are followed. In this video, we'll discuss what an IOR is, why it's important, and the different roles it can take in the import process. We'll have regulatory, engineering, product development, and a distributor share their expertise in a presentation and interactive panel format so you can ask them questions about succeeding in our industry.

How to obtain an NDC Number for your product (ANDA) New Drug Application

An NDC number, or National Drug Code Number, is an identifying number that manufacturers assign to packaged medications. This number can be used in a healthcare setting to accurately identify and track drugs as they are prescribed and dispensed.

Navigating the GRAS process: A guide for food manufacturers

If you're a food manufacturer, you need to understand the generally recognized as safe (GRAS) process. This process determines whether a substance is safe to use in food products without the need for pre-market approval from the FDA. This guide will provide you with a comprehensive overview of the GRAS process, including its history, requirements, and benefits.

Everything you'll want to know about your Medical Device Business Unlocked!

Are you in the Medical Device Industry and want to learn how you can grow your business? Well, marketers, Entrepreneurs, CEO', Business Development managers, and everyone in between is invited to this expert panel to learn about growing your business. We'll have regulatory, engineering, product development, and a distributor share their expertise in a presentation and interactive panel format so you can ask them questions about succeeding in our industry.

Need assistance with Health Canada & U.S. FDA Regulations?

Do you find Health Canada & U.S. FDA Regulations complicated and confusing? You are not alone. Quality Smart Solutions is here to assist exporters and producers of Health Canada & FDA-regulated products such as Food and Beverages, Ingredients VHPs, Natural Health Products, Dietary Supplements, Drugs, Medical Devices, Cosmetics, Cannabis, Homeopathic Drugs, and much more.

Health Canada and FDA Regulatory Insights Webinar

A comprehensive overview of Health Canada and FDA Regulations for the following categories: natural health products, dietary supplements, conventional foods, supplemented foods, cosmetics, OTC drugs, medical devices, cannabis and psychedelics.

Regulatory, Retail & Manufacturing NHP Expert Panel (NPN, NHPID)

This panel of Natural Health Products specialists shares their expertise on Natural Health Products in Canada before taking questions from our live audience. This is the only video you'll ever need to watch in order to learn how to start or improve your profitability in the NHP sector. Regulatory Panelist Mitchell Kiernan: 0:30 Business Development Rob Blais: 8:53 Retail Specialist Tara Marton: 23:26 Manufacturing Specialist: Jiamila Maimaiti 33:42

Regulatory & Market Landscapes of CBD as an NHP: How Safe is CBD?

Our live FAQ session on CBD in Natural Health Products gives you the opportunity to learn about the safety, quality, and efficacy of CBD in Natural Health Products (NHPs). 1. Scientific Committee Summary and Recommendations of CBD as an NHP. 2. Challenges Mixing CBD & NHPs 3. Non-Prescription Usage of CBD & NHPs 4. What could a CBD NHP Monograph Look Like? 5. When will the CBD NHP Pathway be finalized by Health Canada? 6. What impact will this have on the Canadian cannabis market? 7. What can cannabis businesses (primarily processors) do to prepare for this change?

Unlock Food Regulations for your Food Products In North America

In this webinar, Andrew Parshad & Mitchell Kiernan go over how to make sure you are compliant with Food Regulations so your Food Products are ready for sale in North America. Specifically, the webinar focuses on the following: If you import, export, manufacture, or trade food products in North America you may have had trouble with the complex Food & Beverage Regulatory Requirements. The food & beverage industry is growing fast, especially with the growing demand for Non-GMO, Vegan/Vegetarian, and other alternatives.

3 requirements to sell a Natural Health Product in Canada

There are 3 requirements to sell a dietary supplement (called a natural health product in Canada) in the Canadian retail market. Andrew Parshad, president and founder of Quality Smart Solutions, elaborates on these conditions.

Do you find Health Canada and US FDA regulations complicated?

Do you find Health Canada and US FDA regulations complicated? If so, you are not alone. Health Canada and the U.S. Food and Drug Administration (FDA) have a lot of rules and regulations, but not everyone knows them. This is especially true for small-business owners in the food and health products industry. That's why we created Quality Smart Solutions to help our customers with product compliance from importing their goods to exporting their products. Contact us now at info@qualityanswers.ca for more information about how we can help your business grow and be compliant with all the new changes in Health Canada's Food & Drug Regulations

Veterinary Health Products in Canada | Selling, Importing & Registering Your VHP

The market for animal and pet products is growing at a rapid pace. With that, there is also a constant need for compliance, with many Veterinary Health Products being rushed to market. This video will aim to steer you toward compliance with your Veterinary Health Products (VHPs) or Animal Supplements in Canada.

5 Common Pitfalls When Importing Natural Health Products in Canada

The 5 Pitfalls that will be covered in this video include: 1. Not having an Importer of Record 2. Not obtaining approval for sites 3. Not being aware of Site License timelines 4. Not having testing results or labels that meet Health Canada requirements 5. Not knowing the above are legal requirements In this video we'll review the 5 main areas where these two product types differ: 1. The Principal Display Panel 2. Nutrition Facts and Ingredients Listing 3. Health Claims 4. Caution and Risk Statements 5. Company Information

What are (HACCP & PCP) Requirements for GFSI Certification? Hazard Analysis Control Point & PCP Plan

Since the publishing of the Safe Foods for Canadians Regulations in 2017, there is now a requirement for a Preventative Control Plan (PCP) for your food facility or food program. This video aims to explain several different programs and certifications that a food facility may want to consider for your sites or products. HACCP, PCP, or GFSI are GMP-related programs (Training) that can be used in your food processing or storage facility that will help to ensure high-quality and safe products are being made. Having programs like these in place can help protect your company from a food safety incident or issue. The food & beverage industry is growing fast, especially with the growing demand for Non-GMO, Vegan/Vegetarian, and other alternatives.

5 Reasons Why Food Labelling is Important for your Food Products in 2022

Food labelling is an important aspect for consumers across the globe. Food labels are used as reliable sources of information to help consumers make knowledgeable decisions. It is important for consumers to understand how to properly read and interpret food and nutrition labels.

NHPs V.S. Dietary Supplements: 5 Classification Similarities and Differences

Although Dietary Supplement FDA Regulations and Health Canada Natural Health Product Regulations are quite similar, there are some distinct classification factors. In this video we'll review the 5 main areas where these two product types differ: 1. The Principal Display Panel 2. Nutrition Facts and Ingredients Listing 3. Health Claims 4. Caution and Risk Statements 5. Company Information

Food Safety: Everything you need to know to create your HACCP plan in 2022

What is HACCP? A common question that comes up in regulated industries, such as food manufacturing and processing, is “What is HACCP?”. HACCP stands for Hazard Analysis Critical Control Point. HACCP is a widely recognized food processing concept that was developed to enhance the production of safe food.

Performance Updates & System Updates for NHP & Site License Applications Update

Have you heard about the recent update on Performance Standards and System Updates for NHP Applications? Within the past year, the NNHPD has managed to achieve 50% year-to-date performance for new applications and amendments for non-COVID stream I Site License Applications while for stream II the numbers were 81% year-to-date performance for new applications and amendments. 318 site license renewals were completed this fiscal year.

FDA Emergency Use Authorization (EUA) Medical Device Transition Plan in 2022

In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations (EUA). This measure by the FDA was designed to mitigate the stress on the device supply chain and the associated scarcity of certain devices that are critical to the prevention and management of Covid-19. In this video we'll review the 5 main areas where these two product types differ: 1. The Principal Display Panel 2. Nutrition Facts and Ingredients Listing 3. Health Claims 4. Caution and Risk Statements 5. Company Information

What are OTC Drugs in Canada? | License your OTC Drugs with Health Canada

Over-the-counter (OTC), prescription medications, radiopharmaceuticals, biologics, and gene therapies are all drug types. OTC Pharmaceuticals, often known as non-prescription drugs, are health items available in the Canadian market that may be purchased without a medical prescription.

Cosmetic Notification Form Tips: How to complete your CNF

To complete the Cosmetic Notification Form efficiently, it is recommended to 1. Have a complete list of ingredients ready, including composition information of the formula 2. Have a copy of the bilingual product label prepared 3. Know who your manufacturer/importer/distributor is and have their contact information on file. 4. Work with a third-party consulting firm like Quality Smart Solutions, that is familiar with the Canadian Cosmetics Regulations. This way you can have your cosmetic formulas and labels reviewed prior to submission to minimize any pushback from Health Canada.