iCAPA

Are you compliant?

The State of Colorado has published new rules effective January 1, 2021 that require licensees to document and test processes for Corrective and Preventive Action (CAPA) and Recalls, the first in the country. This follows several events raising concern with product quality and safety among both regulators and consumers, reinforcing the need for cannabis companies to have robust quality and compliance capabilities.

What others are saying about iCAPA

"The session was very helpful and informative for me. I can genuinely say it was the most educational conference I have been on in a long time, TIME WELL SPENT!!!"

— Director of Lab Operations, Apothecary Extracts

Why does quality matter?

According to the CDOR MED 2019 Annual Report — Final (May 1, 2020), 13% of medical cannabis flower and trim failed microbial testing due to concentrations of yeast and mold that were over the legal limit. For every 10,000 sq. ft. of cultivation canopy, that equates to >$1 million of failed product annually.
Several Canadian producers have issued voluntary recalls due to incorrect labeling and mold. In the most recent case, over 30,000 pre-rolls listed THC content as 1.09 mg/g when the correct value was 10.9 mg/g — a single error but repeated 30,000 times.
A 2019 study sponsored by Leafly found that of 47 CBD products purchased from a variety of sources, only 51% tested within +/- 20% of the labeled dosage. 23% had less, 15% had more, and 11% had no CBD detected.
In October 2019, the Denver Department of Public Health & Environment (DDPHE) issued a voluntary recall due to potentially unsafe levels of yeast and mold dating back to late April 2019. The recall involved 3 cultivation facilities, 11 manufacturing sites, and 144 dispensaries across the state.

The fact is even the best companies sometimes have quality challenges that require product to be withdrawn from the market(think Tylenol, Toyota gas pedals, and Merck’s Vioxx). Having the capability to quickly, effectively, and efficiently manage the process is critical — and it makes a difference in preserving your brand reputation and bottom-line.

Introducing Integrated CAPA

The GMP Collective in partnership with ILoveCompliance.biz is offering a two-hour educational seminar specifically designed for Colorado licensees to be inspection ready by January 1, 2021. Based upon proven industry best practices and standards, we will provide an integrated model which will address the following (and many other) questions you should have:

How will the new regulations affect my business? ...my customers? ...my suppliers? How do I manage risk?
What new standard operating procedures and training will I need?
How will I know the new process is not only compliant, but effective?
What will it cost to comply, ongoing? Are there tools and approaches to make the process easier?
How can I make this an investment as opposed to an expense, for both customer value and financial ROI?

Thank you to our iCAPA Program Sponsors

Together ILoveCompliance forms a Veteran, Woman, Minority-owned business that supports Cannabis and Hemp clients operating in over 30 states. We create strong compliance programs, streamlining our client’s operations, and reducing the overall risk to their businesses. The mission of ILoveCompliance is to eliminate the burden of compliance for cannabis and hemp business owners. As a minority

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Supply Chain OpEx Consulting makes Fortune 500 supply chain processes accessible to small and mid-market businesses.

Founded on years of real-world industry experience in a Fortune 500 Medical Device/Life Sciences company, our mission is to serve as a Trusted Advisor, delivering Supply Chain Operational Excellence [OpEx] solutions to companies seeking improved efficiency, productivity, service, cGMP quality, regulatory compliance, and sustained financial results.

BSi Group, founded in 1901, enables people and organizations to perform better. We share knowledge, innovation and best practice to make excellence a habit – all over the world, every day.

For more than a century we have been challenging mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth. As a global leader in helping organizations improve, our clients range from high profile brands to small, local companies in 193 countries worldwide.

Akene Consulting is comprised of experienced and uniquely talented CPAs and consultants that seeks to shepherd pioneering cannabis CEOs into the future. The current environment, akin to the Wild West, has created uncertainty, often inducing anxiety and confusion.

Our charge is to help cannabis business owners create a bedrock foundation of policies and practices, instilling confidence and providing clarity so they can focus on what’s important – creating a thriving cannabis enterprise. We believe that sound, thoughtful guidance can transform and elevate cannabis businesses.

Will you be inspection ready?

Let The GMP Collective provide you with experienced-based guidance to be able to confidently say “Yes!”‍

Ready for your iCAPA implementation?

Contact us today to learn more and discuss pricing.

Introducing an Integrated CAPA Program