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Controlling Product Risk through Testing in a cGMP

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Shannon Swantek
Principal Scientist, CEO at Enlightened Quality Analytics
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Concentration 2019
May 30, 2019, Pala, USA
Concentration 2019
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About speaker

Shannon Swantek
Principal Scientist, CEO at Enlightened Quality Analytics

Shannon Swantek is a Principal Scientist and CEO at Enlightened Quality Analytics, LLC who holds broad knowledge of the environmental, natural medicine, and cannabis industries. She has a robust regulatory background in auditing to the ISO 17025 and ISO 9001 standards. Her experience advising cannabis policy and legislation in Oregon, Massachusetts and nation-wide led to her passion for industry education and support in developing technical and quality systems solutions for each license type as the industry matures out of infancy.

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About the talk

This presentation will explore the basics of a cGMP compliant system for food, nutritional supplements and pharmaceutical products and the necessity for cannabis products to meet these requirements now and moving forward. This presentation will also explore the paradigm of creating a comprehensive testing scheme that for product control and optimization in order to control risk while staying competitive in a highly regulated "Point-of-Sale" testing market. A discussion on the importance of understanding analytical data needs associated with each product as well as working with the laboratory to ensure accurate results. In the current market, litigation is uncommon, but many expect it will be one of the many things to ramp up quickly. In supply chain considerations, traceability and validated laboratory data is essential to manage risk in health events, recalls and lawsuits.

01:40 The cannabis industry: current state

03:27 The cannabis industry: staying ahead of the curve

06:57 Controlling risk: the basics

11:15 Why would I want to do more testing?

12:50 HACCP evaluations

15:08 Water testing

16:33 Environmental testing

17:28 In-process product testing

19:11 Product control studies

19:50 Non-conforming product testing

20:20 Where to begin?

22:55 Strategy

26:16 Testing

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So today I'm going to talk about controlling product risk through testing and why I don't believe that the point-of-sale testing scheme that most states are in playing right now is enough little bit of background about me. I actually created some of the first Oregon laboratory legislation with the first pesticide list and the first solvent list and we were charged with creating a point-of-sale system testing scheme. And by the time I left after having talked to people in the food industry in the pharmaceutical industries and in the agricultural industry is actually what

I realized is you can't control everything at a point-of-sale you really have to control your own risk as a processor or producer or cultivator. I think so in the current state of the industry. We all know what a mess. It was a couple of years ago, but it's really starting to come together. There's still a lot of risks. You have a lot of risking your business and in your product and supply chain risk. Do you know what you're getting? Do you know where it came from? Do you know if it's contaminated adulterated? Is it going to be the same every time you have brand risk? A lot of people

are just coming into their branding schemes and when they are not considering their product changing from time to time there brand is at risk of being deleted. Contamination Red Squirrel. Well familiar with pesticide issues in the mouth issues out there right now lost our products Miss dosage recall and you know, the one we're all really scared out of the public health events. So let's examine the point of fasting people here test with compliance Labs currently in what states California, Oregon?

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