April 2022 Issue 31
Harvest & Plume
Welcoming The Tide
I can't believe we've been producing the Monthly Sesh since 2019, and a lot has happened since then. The most obvious development of The Pipeline: Strategies is expanding from people strategies and marketing solutions to adding the Sales PEO, which is our step into the plant-based nutraceuticals, health & wellness, and eco-green initiatives. The Sales PEO came into existence out of necessity when an emerging brand asked me to help market products outside of his home state. After careful consideration, my partner, Lyle Bogorad, and I saw the benefit & opportunity and began the process of evolving into this new business venture. Two years later and we're in soft launch with our Sales PEO! This new development is now focused on finalizing partnerships that include global opportunties with the LUV Brand, Drone Corps, and the World CBD Awards, and exporting to Peru. What's amazing is that this activity and development is to benefit all Sales PEO brand members. Even more amazing is the knowing-feeling that we've created something that has IMPACT on people's lives instead of "just" a financial transaction. At the end of 1QY2022, we shared our first Brag Book proudly detailing our accomplishments and activities. I like the idea of a Brag Book because it allows us to highlight our many successes instead of defending fiscal reports. With so many great things happening, I can't wait to see what the 2QY2022 Brag Book will share but you can rest assured it will include LUV, Drone Corps, World CBD Awards, with more to be announced. Be sure to check out our first Brag Book -here! Thanks to our wonderful contributors for content, photography, creative & post-production, and partnership development. I am in awe of each of you and grateful that we continue raising the bar, in every way.
by KIM MCCARTHY
Thoughts Photo & Image Credits User Guide Instructions April: National Internship Awareness Month The Pipeline: Strategies Announces Internships LUV Brand: Introducing Drone Corps Con Mucho Gusto Zen Page Essential Specifications Hemp Communities Alt-Fi Fumding Options Ionizing Your Home Cesar Benavides: Behind The Lens Events To Attend
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Thoughts
CONTENTS
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User Guide Instructions
Green Star Sponsor: Drone Corps
Photo & Image Credits
Cover Photo by Cesar Benavides Photo by Happy Hour Headshots Photo by Cesar Benavides https://unsplash.com/photos/4LaFanthIOw https://pixabay.com/illustrations/seamless-repeating-tiling-tileable-1889445/ Marketing Pieces Provided by The Pipline: Strategies Marketing Piece Provided by LUV & Drone Corps https://unsplash.com/photos/mZKEIRBStv4 https://pixabay.com/photos/question-mark-exclamation-mark-7046730/ https://pixabay.com/photos/paco-peru-peruvian-landscape-1694024/ https://pixabay.com/vectors/arrow-red-up-symbol-icon-156792/ https://pixabay.com/photos/branding-stationary-store-stamp-2456457/ https://pixabay.com/photos/label-kraft-blank-design-paper-3150731/ Photo Provided by Asa Waldstein Marketing by The Pipeline: Strategies https://pixabay.com/photos/kitchen-home-interior-modern-room-2165756/ Photo by Cesar Benavides Image by Cannabis Investing Forum
Bonus: Learn about The Pipeline: Strategies Sales PEO client brands and how the many applications and utilities of their products may positively impact lives.
To ensure professionals are credited for intellectual property, please participate in the andragogy experience (see opposite page) or reference the following credit list for photos and images:
Enjoy the full learning experience of andragogy - a method of adult learning - by immersing yourself in the formating, layout, and clicking on images to discover opportunities for learning and growing beyond stigmas. As you explore the publications, be sure to look for green stars hidden in plain view - waiting to be found and clicked. REMEMBER: Everything in Harvest & Plume and The Cannabis Sessions is made with intentional purpose and for your benefit. We hope you find the andragogy experience to be educational, enlightening, and enjoyable enough to share with others.
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Harvest & Plume and The Cannabis Sessions are intentionally created to be a resource and a complement to your journey into cannabis & hemp. Whether your journey is for research, scientific revelations, technological innovations, health & wellness awareness, or business needs, rest assured that all featured information and sponsored content meet three critical qualifications for inclusion: Current Factual Non-Leveraged
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We're here to educate, inform, and share. Every issue has current, factual, and non-leveraged information to improve your health, lifestyle, and business.
Celebrate the benefits of internships for both employers and students. Think of it as a joint effort to produce tomorrow's great talent. The Pipeline: Strategies (our parent company) loves creating opportunities which is why we're thrilled to announce our internship program. It's a great way for young professionals to start their careers - through meaningful experiences and reportable projects that end with a panel interview. This panel interview is handpicked from our network and will result in employment or project work. Pefect for the career climber, entrepreneur, or influencer. Check it out on pages 8-11
Hidden throughout this page is four green stars and 20 subscription links. Be sure to subscribe after clicking on a link!
April: National Internship Awareness
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Licensed Unmanned Vehicle
The Drone Corps use artificial intelligence, autonomy, and new quantum sonic technologies on sea, air, and land, piloting LUV WORLDWIDE from a Drone Corps computer in the convenience of your home.
Registered US Department of Labor Apprenticeship TX #93471
LUV Is In The Air
Con Mucho Gusto VitaminCBD Goes To Peru
Kim McCarthy of The Pipeline Strategies presented VitaminCBD™ to a number of interested parties in Peru, including the only state-approved dispensary for all non-THC products.
To be able to reach the international market is another pinnacle that VitaminCBD™ looks forward to earning. A big shout out to The Pipeline Strategies for not only picking our product but sharing our educational push to teach the public about the Endocannabinoid System (ECS).
(Continued, next page)
Authored By Dr. Eric Mitchell, MD FACPE
We're excited to announce that we are looking at the necessary procedures to take VitaminCBD and export it to Peru.
The acceptance of the cannabinoids is nothing new for countries outside of the United States. Much of the research that helped to develop the new cannabinoid system and the benefits of CBD and the other cannabinoids have been done outside of the United States. As America went into a prohibition centered around the cannabis plant dating back to 1937, all incentives to grow hemp were abolished. Cannabis had to overcome the hemp plant’s criminalization that made the plant as a controlled narcotic per the Controlled Substances Act (CSA) in 1970 under the Nixon administration and designated as a Schedule one drug.
(Continued, previous page)
Commit to memory by re-reading this summary SIX TIMES.
Health and Human Services (HHS) of the United States government has held a patent on CBD since 2003.
What is a Schedule one drug: Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.
The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and HIV dementia. Nonpsychoactive cannabinoids, such as cannabidoil, are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention.
In 1999, four NIH researchers applied for a patent because they found that CBD was neuroprotective, neural proliferative and a great antioxidant to fight oxidative stress and free radicals in the brain. This 1999 patent request was granted as Patent US6630507B1 by the United States Patent Office (USPO).
This is how the abstract of that patent reads from July 2003: Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This newfound property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory, and autoimmune diseases.
VitaminCBD™ Is
American-made, organic, third-party tested hemp product formulated by a long-standing research physician, Eric I Mitchell, MD
Zen Page Sponsored By
It is important to remember the DHSEA disclaimer (Not intended to treat, diagnose, prevent, or cure) when developing marketing content.
Establishing and Documenting Specifications. This is the most common violation and one of the easiest to follow. Specifications should be reviewed by Quality and then approved, rejected, or quarantined. This allows potential problems to be identified before items are used in manufacturing or released to the public. Packaging Components: Anything that touches the product should have a specification, including lids, droppers, bottles, and cotton. Components should be food grade and be issued an internal part number, internal lot number, and these should be correlated with the vendor's item number and lot numbers. Labels: Label specifications should include the label size, internal lot numbers, and line items.
Essential Specifications
Here are the free webinarscGMP Basics for Hemp-CBD Companies,Preparing for FDA Inspections, andDistributor Requirements for Hemp-CBD Companiesto support your compliant growth.
By: Asa Waldstein
Essentials For Hemp-CBD Manufacturers:
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
With a lack of clarity happening at the federal level, my advice for hemp cannabinoid companies is to act like they want to be regulated, which is a dietary supplement in the case of ingestible products. These are CFR 111 or cGMPs for supplements.
Here are the free webinars
Commonly overlooked manufacturing, labeling, and marketing essentials ingestible cannabinoid companies need to be compliant.
Operational Efficiency & GMP Compliance go hand-in-hand to create a successful business. My advice is to develop a Quality Management (QMs) with the individual company needs in mind. GMPs are a framework of regulations, but they leave a lot of room for interpretation. This is one reason I suggest hiring dietary supplement experts whenever possible, as they understand the nuances of interpreting GMPs to make sense for the individual company. For example, interpretations look different between a $1MM supplement company and a $20MM supplement company, and those regulatory interpretations look different than a pharma company. Having a properly functioning QMs is essential, but an overburdensome approach to Quality is restrictive. I see hemp companies hire exquisite pharmaceutical managers to develop their QMs. They get what they pay for, a rock-solid system that is pharma-level, but is this needed in a current small-to-midsize cannabinoid company? It doesn't usually make sense and often raises costs, lead times, and complexities that unnecessarily hinder company growth.
Documentation is a core principle of GMPs and the mantra "If it's not written down, it didn't happen" is essential to keep in mind. Under GMPs, companies are required to destroy their old labels. I once saw a company completing this task; however, they were not documenting the label destruction. This could have been a FDA 483 violation simply because of the lack of documentation. Learn more about the difference between FDA 483s and warning letters here.
Disclaimer: The educational information provided here is for informational purposes only and does not constitute legal or regulatory advice. Contact an attorney for specific legal advice.
Checked & Verified By System: This is just like it sounds. One person checks a number, such as an ingredient weight in a blend, and the other person verifies the same. This should be completed simultaneously, creating complexity for small one-person manufacturing companies.
Interpreting The Regulations: There is lots of room for interpretation, and it's hard to know how to implement them in a way that makes sense for your company. The following page is a learning activity with an example of how two cGMP approaches get the same outcome.
Raw Materials & Finished Products: You are getting the picture that everything should have a specification. This includes all product ingredients, and, of course, the product itself needs written specifications. For example, if the product specification was a green, herbaceous free-flowing powder and the ingredient/product was clumpy and yellow, this would signify that the product is out of specification and should be rejected or quarantined for further investigation.
Learning Activity
Option #1:
Flower Bud, herb, ganja green, pot, whatever you choose to call it, the dried and cured plant material (mainly the female buds) that is ground, rolled, and packed into bowls. Many consider this form of consumption to be the most natural because it is exactly as nature intended, with every compound intact and without interference or alteration. Smoked through bongs, bowls, joints, smokeables, steam chalices, and various other methods used throughout history. Many prefer this method of consumption as it offers effects almost instantaneously, whereas many other methods have alonger onset period. Pros: Quickness of Onset Full Spectrum Natural Cons: Potent Smell Low Bioavailability
"This is an excellent example of why you should hire a supplement executive who understands not just Quality Systems but also Operations. Implementing a quality system from a compliant and operational perspective will help your company grow lean and efficient." - Asa Waldstein
Option #2:
Hire a full-time member of Quality to stand over the packaging line to be checking labels, lot numbers, fill levels, etc. If you can't afford to hire this professional, you would be wise to interpret the regulations in a way that makes sense for you.
Quality staff starts on the production line, ensuring the bottle fill level is correct, the correct labels are applied, the right product is used, etc. The Batch Production Record (BPR) allows a Packaging Manager or Lead to be responsible for in-process checks. Alternatively, you could place Quality responsibility back to the production workers who pay dividends, as it helps all employees become an extension of Quality. This reduces the US-vs-Them mentality with Production and Quality and supports the virtuous operations ecosystem. All departments are working together for a common goal.
Asa Waldstein is a 20-year dietary supplement manufacturer and marketer and principal of Supplement Advisory Group, specializing in practical regulatory support for dietary supplement and hemp product marketers. Asa focuses on finding marketing risk and providing practical marketing solutions on the web, social media, and product labels.
This aspect of the regulations leaves room for interpretation, but the goal is to ensure the products are manufactured within specification.
Scenario Discussion: GMP regulations state design manufacturing processes to ensure product specifications are consistently met.
Presently, we are in the process of committing to collaborations, partnerships, and sponsors with the following brands and associations:
By Kim McCarthy, Founding Partner & People Strategist
Industrial hemp is exploding with opportunities that include medicine, plastics, and construction material, to name a few. Building with hemp materials has many benefits that far exceed traditional building materials: Breathability Thermal Performance & Heat Loss Acoustics Fire Resistance Carbon Emissions Recyclable Superior Insulation
World Hemp Alliance
Please enjoy an abridged version of the Hemp Communities slide presentation. Please schedule a personal presentation.
Throughout our affiliations and research, we found an awesome hempcrete building block product that make constructing buildings easy and sustainable. Consider your next build or project with industrial hemp!
Hemp Communities
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Various Test Results
(fungus)
Using The Ionizers.
Ionize Your Home
The air that you breathe indoors is filled with airborne viruses, allergens, bacteria, germs, molds, and other harmful, toxic particles that pollute the air making you tired, less productive, and adding risks to your health.
Proven to be effective in killing 99% of harmful products. 10 billion to 1 trillion ions per second. Increases HVAC performance. Non-detectable levels of ozone <0.001 ppm.
Documented
Main source of these documented studies include NCBI.gov reports).
Scientists Have
Ionizers have been tested and were found to be 99% effective in neutralizing:
Cladosporium Cladosporiodes
Scientific research has shown that filling the air with ions eliminates particulate matter, ammonia, viruses, and bacteria while showing positive results reducing.
Escherichia coli MRSA
Coronavirus Influenza (H1N1 & H5N1)
Aspergillus
(mold)
(virus)
(bacteria)
Post-Production
Cesar Benavides enjoys being behind-the-camera to capture images and moments. He was a live remote cameraman covering professional surfing competitions, nationally televised red carpet events, and the 1996 Japanese Embassy hostage crisis (Lima, Peru). He was a highly sought after director in South America, consulting with advertising agencies on commercials while pitching Latin American marketing campaigns. After moving to the United States, his work remained focused on camera & production (pre/post), eventually returning to the studio where he consulted and advised for professional agencies & foundations and student creators. Expanding from media, advertising, and studio production, today Cesar enjoys the peace and serenity of landscape photography and drone videography. "It takes a lot of scouting locations and researching weather & astrological events to prepare for capturing a landscape image."
Behind The Lens
Film Director
Cesar's services may be reserved for your commercial, grow, farm, or other business needs.
Photographer
Commercial Drone Operator
Studio & Technical Consultant
Videographer
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Events To Attend
April 20, 2022
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