Podcasts about good manufacturing practices

The world of ISO is often stumbled into as a result of being tasked with either Implementing or maintaining a Standard for a business. It is rarely a desired career path, and yet there are thousands of ISO professionals from all corners of the globe. We're continuing with our latest mini-series where we introduce members of our team, to explore how they fell into the world of ISO and discuss the common challenges they face while helping clients achieve ISO certification.   In this episode we introduce Derek Hall, a Senior Isologist® and Sustainability Lead at Blackmores, to learn about his journey from spending 40 years in the printing industry to becoming an ISO Consultant, and what drives him to help clients on their ISO journey.   You'll learn ·      What is Derek's role at Blackmores? ·      What does Derek enjoy outside of consultancy? ·      What path did Derek take to become an ISO Consultant? ·      What is the biggest challenge he's faced when implementing ISO Standards? ·      What is Derek's biggest achievement?   Resources ·      Isologyhub ·      Climate Change Amendment Workshop   In this episode, we talk about: [02:05] Episode Summary – We introduce Derek Hall, a Senior Isologist® here at Blackmores, to discuss his journey towards becoming an ISO consultant who specialises in ISO 9001, ISO 14001 and ISO 22716.   [03:45] What is Derek's role at Blackmores? Derek is a Senior Isologist® with Blackmores, supporting companies with maintaining systems, undertaking internal audits, and supporting with implementing new systems to gain certification utilising our Isology methodology. His passion lies in the realm of sustainability, embedding it within the management systems of many of our clients regardless of any certification to any dedicated sustainability Standard. Derek was worked with a number of sectors, including:- ·      Media ·      Printing ·      Constructions ·      Cosmetics ·      Recycling ·      Electrical ·      Public Sector & NHS Derek enjoys the learning aspect of working with new industries, and values the input from all personnel involved, from top management to those on the shop floor. He well and truly immerses himself within each company he works with to learn about their values and how ISO can best support their vision. [08:30] What does Derek enjoy doing outside of consultancy?: Derek has a few varied hobbies, including oil painting born out of his other passion, photography. He often uses his own photos as subject matter for his paintings. He also trains 4-5 times a week at his local karate club, which caters for all ages and skill sets. Derek has diligently worked his way up to black belt over the 17 years he's been attending, and offers his skills to teach sessions. He appreciates the respect that karate teaches, in addition to gaining more knowledge on other points of view. With such a varied class, there's always something new to learn. The Australian based club he attends is called GKR Karate. [12:20] What was Derek's path towards becoming an ISO Consultant?: Derek's journey starts back in the 60's, where he worked in commercial photography, taking pictures on the progress of various building works, and products for furniture stores. He used to work with plate photography, which was a rather old school method even back then! This was coupled with more modern methods such as 35 millimeter film. He recalls witnessing the building of the Thames barrier, taking pictures to help monitor the amount of water coming through the barrier. After that he moved onto work for a printing company in Barnet (Hertfordshire), which specialized in advertisements and signage for furniture stores. From the shop floor Derek worked his way up to becoming a printer operative. This company evolved to include screen printing, which allowed for more versatile applications such as clothing or certain plastics. After spending 3 and a half years there he moved on with a friend to start their own printing company in Watford, which continued until the 70's. In the 70's Derek joined a much larger printing company based in Southgate London. Here he was involved in the printing of cinema posters for theatres, and musical groups. Derek remained there for 40 years, watching it evolve to larger scale printing for retail markets such as HMV Records and curry's, in addition to bus advertisements. During the 90's, there was a larger push for quality Standards, their clients wanted more assurance that they were following established guidelines and could produce the quality they were after. So, Derek was tasked with Implementing BS 5750, ISO 9001's precursor, and BS 7750, ISO 14001's precursor. The company then got involved in an eco management audit scheme called EMAS, which required the reporting of environmental impacts. It was similar to ISO 14001, but it's regulatory reporting requirements more closely align with modern schemes such as ESOS. They also introduced other schools of thinking such as Kaizen, for the purpose of continual improvement. At this point, Derek became very involved with sustainability standards, and developed a concept called ‘The Tree of Sustainability', which included 9 branches for improvement. This was introduced due to the fact that their industry by its current nature, wasn't very sustainable. There was a lot that could be done to reduce their impact. Through developing that project Derek got involved with the DTR project called ‘The Sigma Guidelines', a backed scheme run by the BSI forum and The Accountability Institute. These guidelines outlined a 3-year project to identify what sustainability meant to them and how it could apply to their industry. The result of their work on this project was then submitted to various awards, netting them a number of sustainability awards and The Accountability Institute Awards. That company continued its operations until 2007, leading to Derek joining Blackmores first year of operation in 2008. Derek is leading us down a similar sustainability path by encouraging us to become a signatory of the Terra Carta, an initiative including 100 different actions for nature, people and planet. [26:40] What is Derek's favourite aspect of being a Consultant? – Derek has a few, including: Building relationships with clients – Many of Dereks clients have been working with him for over 10 years. He's as much friends with them as he is a work colleague. Flexible approach – Consultancy can be delivered in many different ways, allowing for hybrid working. This flexible approach also applies to the way we achieve internal targets, with each member of the team being given specific goals with the freedom to choose how they reach them. Everyone has their own way of working, and we encourage all members of the team to work how they like with the opportunity to learn from each other. [28:35] What Standards does Derek specilaise in and why? Starting with: ·      ISO 9001 Quality Management: A core foundation that many businesses start with when diving into the world of ISO Standards. Derek started with it's predecessor, and has watched it develop over the years. He appreciates the value it can bring, especially to SME's who are looking for a scalable model for success. ·      ISO 14001 Environmental Management: Derek is a fan of sustainability in general, and encourages everyone to implement some of it's requirements as part of any project.   ·      ISO 22716 Good Manufacturing Practices for the Cosmetics Industry: A rather niche quality standard for the cosmetic industry, this Standards works well in collaboration with ISO 9001 for a more holistic approach. ·      ISO 45001 Health and Safety Management: Derek picked up this Standard as a result of his work with the construction industry. It's importance as a tool to prevent harm to humans cannot be understated. ·      ESG: Derek has been working closely with his colleague, Ali Henshaw, to develop an ISO based framework to tackle ESG requirements. This includes inputs and requirements from guidance standards such as ISO 20400 (Sustainable Procurement) and ISO 26000 (Social Responsibility) ·      ISO 22301 Business Continuity: A lot of organisations are looking to implement aspects of business continuity as a result of the ever-changing resilience landscape. [32:20] The link between business continuity and climate change: We have seen client requirements evolve to include various elements of business continuity in response to the increasing threats of cyber incidents and climate change related issues. This is reflected in the recently introduced Climate Change Amendment to many commonly implemented ISO Standards. This requirement ensures that businesses consider their impact on climate change in addition to, how and if they would be affected in turn. If you would like to learn more about this, listen to a previous episode or watch our Workshop playback. [34:20] What is the biggest challenge Derek had faced during a project and how did he overcome it?: Derek took on the challenge of implementing ISO 22716, when he knew very little about the Standard and the cosmetics industry as a whole. Though there were a few stumbles on his first attempt, they managed to get certified without issue. That same company then wanted his help to implement ISO 14001, which is a tough ask for the cosmetics industry. There are a lot of factors to consider, such as: ·      What is their environmental impact? ·      Where are you sourcing materials? ·      Are the ingredients shipped from across the globe or sourced locally? ·      Is there any animal testing involved? ·      How sustainable was their supply chain? There was a lot to get through, but it was a beneficial choice to get a full picture of their environmental cost. Later, the company opted to implement ISO 9001 in addition to their existing Iso 22716 and ISO 14001 certifications. This fit nicely as both ISO 22716 and ISO 9001 are quality based Standards, they complemented each other and created an effective and holistic management system. [27:20] What is Derek's proudest achievement?  Derek received an MBE from the late Queen for services in the environment in 2005. This was earned through his sustainability work within the print industry. For those not familiar, the Queens Award (now the King's Award) is a prestigious award that requires 3 levels of review and vetting before winners can be announced. It includes checking evidence provided and the financials involved to verify if applicants have achieved what they say they have achieved. Derek, along with his wife and daughters, were invited to the palace to meet the queen and receive his award. If you'd like any assistance with implementing ISO standards, get in touch with us, we'd be happy to help! We'd love to hear your views and comments about the ISO Show, here's how: ●     Share the ISO Show on Twitter or Linkedin ●     Leave an honest review on iTunes or Soundcloud. Your ratings and reviews really help and we read each one. Subscribe to keep up-to-date with our latest episodes: Stitcher | Spotify | YouTube |iTunes | Soundcloud | Mailing List

SUMMARYIn this special episode of Vibe Science, hosts Ryan Alford and Chris Hansen revisit key insights from past discussions on the science of health optimization and longevity. They engage with biohacking expert Dave Asprey, founder of Bulletproof Coffee, who shares his journey from obesity to fitness, emphasizing the importance of efficient exercise and nutrition. The conversation explores how personal health influences business success, strategies for managing "bad days," and the value of investing in longevity. Dr. Joel Wussow underscores the need for evidence-based wellness practices, while Josh Felber highlights emerging treatments like peptides and the importance of high-quality supplements. Dr. Vanessa Pavey, a naturopathic doctor from Life Extension, also provides expert insights into longevity and proactive health strategies.TAKEAWAYSHealth and wellness focus, particularly in the context of biohacking.Personal health journeys and experiences, including weight loss and fitness optimization.The relationship between personal energy management and business success.Strategies for managing "bad days" and the impact of internal and external challenges on health.The importance of investing in longevity and health optimization for overall well-being.The role of evidence-based practices in health claims and the dangers of misinformation.Lifestyle optimization, including nutrition, sleep, and hormonal health considerations.Discussion of emerging treatments, such as GLP-1 agonists and peptides, for weight loss and metabolic health.Establishing healthy habits, including exposure to sunlight, breathing exercises, and cold plunging.The significance of high-quality supplements and transparency in the supplement industry.ENJOY 30% discount codeVIBESCIENCE - (add code at checkout) https://shop.roga.ai/discout/VIBESCIENCE Follow us on Instagram: @Vibe.Science Subscribe to our YouTube Page: www.youtube.com/@Vibe.Science

We sit down with Alisa Sano, a public health auditor, to explore the world of dietary supplements and the critical role Good Manufacturing Practices (GMP) play in ensuring product safety and quality. Alisa sheds light on the hidden details behind supplement labels, how consumers can make informed choices, and the importance of GMP certification in protecting public health. If you've ever wondered how to tell the difference between safe and risky supplements, this conversation is for you. Alisa Sano is a public health auditor. She discusses the KevinMD article, "GMP vs. non-GMP: the hidden truth about your supplements." Our presenting sponsor is DAX Copilot by Microsoft. Do you spend more time on administrative tasks like clinical documentation than you do with patients? You're not alone. Clinicians report spending up to two hours on administrative tasks for each hour of patient care. Microsoft is committed to helping clinicians restore the balance with DAX Copilot, an AI-powered, voice-enabled solution that automates clinical documentation and workflows. 70 percent of physicians who use DAX Copilot say it improves their work-life balance while reducing feelings of burnout and fatigue. Patients love it too! 93 percent of patients say their physician is more personable and conversational, and 75 percent of physicians say it improves patient experiences. Help restore your work-life balance with DAX Copilot, your AI assistant for automated clinical documentation and workflows. VISIT SPONSOR → https://aka.ms/kevinmd SUBSCRIBE TO THE PODCAST → https://www.kevinmd.com/podcast RECOMMENDED BY KEVINMD → https://www.kevinmd.com/recommended GET CME FOR THIS EPISODE → https://www.kevinmd.com/cme I'm partnering with Learner+ to offer clinicians access to an AI-powered reflective portfolio that rewards CME/CE credits from meaningful reflections. Find out more: https://www.kevinmd.com/learnerplus

In the world of pharmaceuticals, companies aim to operate under GMP guidelines — a set of production and manufacturing measures to assure standards for medicinal products. But too often, the reality is anything but that.  “Officially, GMP stands for ‘Good Manufacturing Practices,'” said Dr. David Schneider, the founder and CEO of Qualifyze. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Shop Morphus SupplementsMorphus Sleepus Signs & Symptoms Survey 103+ Symptoms of Perimenopause and Menopause In this episode of Menopause Reimagined, Andrea Donsky, nutritionist, Menopause Researcher, Menopause Educator, and co-founder of Morphus, interviews Jason Mulligan, the President of Eurofins Botanicals Testing Inc. The discussion focuses on the critical role of third-party testing in the dietary supplements industry, particularly for products aimed at women experiencing perimenopause and menopause.Key Points:Andrea shares her journey in creating Morphus, emphasizing the importance of research and efficacy in supplement formulation and the significance of third-party testing for consumer safety and product integrity.Understanding Third-Party Testing: Third-party testing is necessary to ensure that supplements contain what they claim and are free from contaminants. The discussion focuses on the Certificate of Analysis (C of A) and its importance for consumers.The evolving landscape of dietary supplements and the challenges brands face in maintaining quality and compliance.The impact of regulations, such as the Dietary Supplement Health Education Act and Good Manufacturing Practices, on the industry.Consumer Trust and Brand Integrity: Building trust with consumers through transparency and rigorous testing is essential. How brands like Morphus can differentiate themselves by prioritizing quality, ethical practices, and testing to provide brand owners and consumers peace of mind.The importance of nutrition, lifestyle, and wise supplementing, including the fact that supplements take time to work and how important it is to listen to your body.Jason brings up an important point: how you feed yourself and what you eat to feed your microbiome are distinct.Links mentioned during the show:Examine.comNational Center for Natural Products Research questions @ wearemorphus.com======Shop Morphus Supplements: https://bit.ly/3R1bd3D

"For most American adults, a strong foundation in supplementation can be built with five key nutrients: a high-quality multivitamin, magnesium, omega-3 fatty acids, probiotics, and digestive enzymes."Are you frustrated by the lack of transparency in the supplement industry?Overwhelmed by the endless options and claims on supplement labels?Unsure how to distinguish high-quality, effective products from ineffective ones?Join us as we chat with Jared St. Clair of Vitality Nutrition and host of the Vitality Radio Podcast about the often convoluted world of dietary supplements. In this episode, Jared pulls back the curtain on questionable practices by some companies and shares his 'vital five' must-have supplement recommendations.Learn how to spot trustworthy brands that prioritize your health over profit, and gain adept knowledge on supplementing wisely. Tune in to Season 3, Episode 17 of the Gutsy Health Podcast! Show Highlights: 00:00 - Episode start02:25 - Jared's background as health store manager turned owner and radio show host 12:52 - The impetus for creating his own product line of supplements17:28 - Jared shares his "vital five" supplement recommendations18:28 - Why multivitamins like Centrum are a waste of money25:41 - Praise for companies with high-quality standards and commitment to purity29:13 - Direct-to-consumer business models that allow for higher quality at lower prices33:05 - Risks of long-term use of proton pump inhibitors (PPIs) 34:14 - cGMP (current Good Manufacturing Practices) in the supplement industry36:10 - Are fillers and flow agents in supplements something to be mindful of?39:50 - Differences between synthetic and natural/food-based sources of nutrients47:59 - Why you need more magnesium and methylated B vitamins49:25 - Voting with your dollars to support ethical companies and drive real change50:33 - Jared's top picks for omega-3 supplements58:18 - How and where to start your supplement journey1:00:52 - The gut-brain connection and the link between IBS and depression1:06:19 - Guidance on selecting a high-quality probiotic supplementImportant Links: Gutsy Health Website - https://www.mygutsyhealth.com/Gutsy Health Podcast IG - https://www.instagram.com/gutsyhealthpodcast/Reach out to Provo Health and schedule a consultation with Dr. Jeff Wright by calling 801-691-1765Connect with Jared St. Clair on:Vitality Nutrition - https://vitalitynutrition.com/Vitality Radio Podcast with Jared St. Clair - https://podcasts.apple.com/us/podcast/vitality-radio-podcast-with-jared-st-clair/id1499760048Instagram - https://www.instagram.com/vitalitynutritionbountiful/Reach out to Vitality Nutrition by calling 801-292-6662 or visit the shop on 107 South 500 West, Bountiful, UT 84010Links Mentioned:Jared's Vital 5 - https://vitalitynutrition.com/collections/vital-5Just Ingredients Podcast with Karalynne Call - https://podcasts.apple.com/us/podcast/just-ingredients/id1557557205The Great Debate  in Probiotics: Human Strains vs. Spores - https:Send us a Text Message.

Yes, we CAN utilize Current Good Manufacturing Practices (cGMPs)! Hear from inspired producer, baker, and entrepreneur Shamilla Roberts and Carolina Farm Stewardship Association's Food Systems Specialist Keisha Rainey on how CFSA's cGMP online module program has helped Shamilla grow her food business. We discuss how the module is a great foundation for building thriving, food-safe businesses, preserving peak harvests, and how more accessible community preserved foods can help us realize a better food future.Carolina Farm Stewardship AssociationCFSA Events & TrainingsGreen Raven OrganicsIf you are interested in CFSA's CGMP online modules, please contact Keisha at keisha@carolinafarmstewards.org

Prepare to have your assumptions challenged as Dr. Chris Lockwood, an authority on dietary supplement regulation, joins us to demystify the layers of oversight that govern this often-misunderstood industry. You'll gain a newfound appreciation for the meticulous standards that dietary supplements must adhere to, thanks to the Dietary Supplement Health Education Act and the stringent Good Manufacturing Practices. Our enlightening discussion with Dr. Lockwood cuts through the myths, providing a detailed look at the definition of adulteration, the precise categorization of supplements, and the rigorous ingredient criteria that ensure consumer safety.Adulteration in dietary supplements: much ado about nothing? BIO: Dr Lockwood is one of the foremost experts in performance nutrition and bridging ideation to successful commercialization, Dr Lockwood is unique in his cross-disciplinary expertise. He currently serves as VP of Scientific Affairs for Nutrabolt, is ranked within the top 91st percentile of all published researchers within his field, is the lead inventor on six patents, and previously served as a Senior Category Director at GNC, Editor-in-Chief of Muscle & Fitness and M&F Hers magazines, and CSO of 4Life Research. He also served as Lead Nutritionist for the critically acclaimed HBO Max Series, WINNING TIME, and has provided personalized nutrition for Academy Award-winning actors Matthew McConaughey and Adrien Brody, and Grammy-nominated singer/model Ciara Harris, just to name a few.

In today's episode of Grow Sessions, we  explore the world of cannabis and its evolving standards. Joining us is our guest David Vaillancourt, a renowned expert from The GMP Collective. Good Manufacturing Practices, commonly referred to as GMPs, play a crucial role in ensuring that products are consistently produced and controlled according to strict quality standards. These practices are not exclusive to the cannabis industry; they are essential across all sectors. Just like any product you find on the shelves of your local grocery store, cannabis products must adhere to specific GMPs to guarantee their safety and quality.Intriguingly, the cannabis industry is still relatively young and rapidly expanding. As a result, there is ample room for improvement in ensuring the highest standards of product safety. In our latest episode, titled "GMP Standards and the Global Cannabis Market," we delve deep into this topic, shedding light on the importance of GMPs and their impact on the industry. Together we explore the current state of GMP standardization and discuss the potential for advancements in ensuring the highest level of product safety in the cannabis industry.Join us as we embark on this important journey of understanding and enlightenment and unravel the complexities and possibilities within the realm of GMPs and their role in shaping the cannabis industry.About David Vaillencourt, GMP CollectiveDavid Vaillencourt, holds a Master's of Science and is the CEO of The GMP Collective and Founder of the S3 Collective, is one of the most respected and effective change leaders in the cannabis industry. Combining his passion for a data driven approach with safety and quality, his group focuses on establishing and enabling the utilization of scientifically sound industry standards, encompassing Good Manufacturing Practices, risk mitigation strategies, and comprehensive supply chain solutions Since 2017, he has been an active member of ASTM International's Committee D37 on Cannabis, now serving as the elected Vice Chair. In this role, he empowers over 700 fellow volunteers spanning six continents to leverage the accredited open and transparent process that brings government, academia, industry, consumers, and other relevant stakeholders to develop consensus product safety standards based on science and data. As a public speaker, educator and connector, David emphasizes the importance of unbiased consensus standards in fostering a reliable and safe marketplace.David's most important initiative to date is the launch of the S3 Collective. This exclusive, agnostic nonprofit foundation is the first of its kind and will effectively connect all standards and best practices to policy and regulation to build an international framework. When not working, you can look for David in the Colorado backcountry skiing and trail running with his dog, Humphrey.To learn more, please visit GMP Collective.Thanks for listening. Be sure to subscribe to our podcast to receive upcoming episodes.

We're excited to introduce Cindy Collins, the visionary behind Euphoric Herbals. Her herbal journey began during her first pregnancy, where she discovered the remarkable benefits of herbs like Red Raspberry Leaf for women's health. With a culinary arts background, Cindy approaches crafting herbal remedies uniquely, combining delightful flavors with potent health benefits. She shares how she integrated herbal remedies into her family life, raising her three boys amidst a rich herbal environment.As a doula, Cindy's experiences have influenced her work in creating tailored herbal products for clients during pregnancy, postpartum, and breastfeeding. We also explore the inspiring growth of Euphoric Herbals, starting as a passionate hobby and blossoming into a renowned brand.Throughout our chat, Cindy emphasizes sustainable sourcing and the significance of Good Manufacturing Practices to ensure the safety and efficacy of her herbal products. Join us for an insightful conversation with this herbal trailblazer!Instagram: @euphoricherbalsPinterest: euphoricherbals

Standardizing the phage therapy industry through processes like clinical trails is the way to go . One of the fundamental steps to broader use of phage therapy and successful therapy is producing phages following Good Manufacturing Practices (GMP) and JAFRAL is the leader in this field. In today's show we sit down with JAFRAL's founder and CEO Dr. Frenk Smrekar, a visionary who has been working on the development of GMP for bacteriophages throughout his whole career. Let's give a listen to his journey of founding the company and his observation and thought on the phage therapy field development through a GMP perspective. Learning more about JAFRAL @https://jafral.com A review paper on GMP in Phage Therapy by https://doi.org/10.3389/fmicb.2020.01161

If you are in the consumer healthcare industry, you probably know about GMPs, or Good Manufacturing Practices. But what do they specifically mean when it comes to dietary supplements, and how do VMS companies prepare for an FDA inspection? More Information: CHPA Chat: The History of DSHEA and Its Founding Mothers and Fathers With special guests: Larisa Pavlick, Senior Director, Product Quality and Technical Affairs, CHPA, Josh Long, Associate Editorial Director, Natural Products Insider, Informa Markets Health and Nutrition, and Asa Waldstein, Principal, Supplement Advisory Group Hosted by: Anita Brikman, Senior Vice President, Communications & Public Affairs, CHPA; and Executive Director, CHPA Educational Foundation 

Did you know that the FDA never had the authority for beauty product recalls? Or that beauty brands didn't have to disclose potential fragrance allergens on ingredient lists? Or that beauty companies didn't have to report adverse events to the FDA? All of that is about to change. In late December of last year, a bill passed in Congress implementing a massive and long-overdo update to the FDA's regulatory oversight for the beauty industry: Thanks to the Modernization of Cosmetics Regulations Act (MoCRA), the beauty industry will better align itself with supplement manufacturers—and even closer to the EU, which is often held up as the standard for cosmetic regulation. In this bonus solo episode, mbg beauty director Alexandra Engler walks through the exciting changes, what we now know, and what it all means for you, the beauty consumer. Show notes: - Read the mbg article about MoCRA. - Read the full MoCRA PDF. - Check out the FDA's Good Manufacturing Practices. - Read more about Mia Davis. - Read more about Krupa Koestline & listen to her CBS episode. Follow the host: @alex_blair_ Call in: sayhi.chat/cleanbeautyschool Comments: podcast@mindbodygreen.com Sponsorship inquiries: sales@mindbodygreen.com 

Dr. Claude Khalil An accomplished seasoned pharmacist specialised in the pharmaceutical industry, her career path is paved with sound knowledge of Pharmaceutical sciences, regulations, and quality management systems. Her passion for project management and healthcare was translated by giving back to community in Teaching and Training Pharmaceutical sciences and Project management frameworks in well-known universities. Claude graduated from Saint Joseph University Faculty of pharmacy, Beirut. She holds an MBA degree from Newport University California. She is a Project Management Professional certified from Project Management Institute  Her major strengths are in the wide and deep knowledge of current Good Manufacturing Practices, development of generics formulations, and pharmaceutical and health care regulated environment, with an important experience in Project management for the healthcare sector. In addition, she is accredited for Organizational transformation and Quality Management Systems. She is a speaker at various national and international conferences related to Healthcare and Project management. You can connect with Claude on LinkedIn and Twitter   If you enjoyed this episode, please hit subscribe so you get all the recent conversations with professionals from around the world working with Quality.

ISO 22716 sets out the framework for a quality management system for anyone involved in the manufacture of cosmetics and other healthcare related products. This is not only limited to production but also the control, storage, and transportation of products, including the purchase of raw materials, components and packaging material. While this Standard's focus is on the manufacture of cosmetics, many of the requirements can apply to any manufacturing process, especially those that involve a risk of contamination. Today, Mel is joined by Derek Hall, a Senior Consultant here at Blackmores, to talk through the main structure of the Standard and how it can be applied. You'll learn What is ISO 22716? Who does ISO 22716 apply to? How is ISO 22716 structured? How ISO 22716 can be applied   Resources isologyhub Blackmores ISO 22716 Implementation The Checklist Manifesto   In this episode, we talk about: [00:35] A description of ISO 22716 Good Manufacturing Practices – A supporting Standard for the manufacture of cosmetics [01:20] Why are we talking about such a niche standard? It's one of our most popular standards via website enquiry, so we'd like to share our knowledge

Color coordinating is more than looking cool.lol it also helps against foodborne illness and cross-contamination as well as many other uses.Liz StasiewiczPhone: 1-800-456-5624E-Mail: kochsupplies@bunzlusa.comwww.bunzlpd.comwww.bunzlpd.com/interactive-catalogsMatt Morrow RemcoP: 317-876-9856 | F: 800-585-8619M: 901-457-9543 www.remcoproducts.comShop Bunzl https://bit.ly/3moKuifContact us atThe Meat Blockhttps://www.instagram.com/themeatblock/https://www.spreaker.com/show/2220980Questions https://m.facebook.com/groups/548355638886041Travis Facebook@AmericanButcherwww.instagram.com/americanbutcherwww.spreaker.com/user/americanbutcherTravismeatStockstill@gmail.comDavid www.instagram.com/afarmbutcherDavid@infieldontable.com

Stacey Lloyd is a microbiologist and GMP complaince specialist. She founded the Kratom Vendors Association to help kratom vendors comply with Good Manufacturing Practices. In an unregulated kratom world, the need for quality control for a psychoactive substance is essential for the future of a legal, regulated, and legitimate kratom market. We talk about what … 84. Kratom Vendors’ Association Founder Stacey Lloyd Read More » The post 84. Kratom Vendors' Association Founder Stacey Lloyd first appeared on Kratom Science.

Jennifer Bruce has “20+ years of industry experience in establishing and implementing quality systems for drugs, OTCs, biologics, dietary supplements and cosmetics from early phase development through commercialization” (from her LinkedIn). She became disillusioned with the pharmaceutical industry, and in 2019 discovered the need for quality assurance in the kratom industry. We talk about why … 83. Quality Compliance Expert Jennifer Bruce on Kratom Vendors and GMP Read More » The post 83. Quality Compliance Expert Jennifer Bruce on Kratom Vendors and GMP first appeared on Kratom Science.

The Turkish Pharmaceuticals and Medical Devices Authority recently published the (1) Guideline on the Classification of Diversification and Variation Applications; (2) Guideline on Communication, Organization and Responsibilities of Stakeholders in Market Control Programs; (3) Guideline on the Good Manufacturing Practices in Human Medicinal Products Manufacturing Plants; (4) Announcement on Annotation/Revision Procedures and Transition to the New Type Licenses; and (5) updated the Precautions to Adopt in Clinical Trials against the COVID-19 Pandemic.

Standards in Cannabis Food Manufacturing And Merril Gilbert And Rhiannon Woo today on NCIA's Cannabis Industry Voice with Bethany Moore only on Cannabis Radio. Merril Gilbert is the Co-founder and CEO of TraceTrust TraceTrust is a nationwide cannabis and hemp manufacturing compliance company advocating for safe consumer experiences through HACCP training and Good Manufacturing Process (GMP) Certifications. Merril has 25 years of experience working in the food and beverage industry and has been working in cannabis for over 6 years. Merril is the past chair of the NCIA Education Committee and a current member of the Risk Management and Insurance Committee. Rhiannon is the Co-founder and Chief Science Officer of TraceTrust. She is a sought-out leader in Food Safety development and protocol and is an expert in Good Agricultural Practices, Good Harvesting Practices, Good Manufacturing Practices, HACCP, and the Food Safety Modernization Act. She is the Secretary of NCIA's Hemp Committee.

Dave D Mindset New Product Launch soon! Pre Launch ExcitingNew Product- e mail-How Changing Your Mindset Can Change Your Profits-entrepreneur, you and your business are connected. Your life will influence the business and vice versa. The ways in which you respond to the events of life have a direct impact on the way you conduct your business, so understanding this connection can improve your company.How great would it feel if you had twice the amount of money in your pocket every week? That's right, I'm proposing you have a part-time side hustle. How GREAT would it feel to add another weekly check? Well, this doesn't have to be a fantasy. You can do it, but you need a system to succeed... that's why we created the EASY 3-STEP COMPANY TOUR. Bottom line... Think about it... Doing what you want, when you want, not when you can. You have all to gain and nothing to lose. We all work together. Don't get left behind. Click the Company Video Tour link to CREATE YOUR FREE ACCOUNT.What's so special about CTFO products... Have you ever seen someone in their 20's, 30's and even 50-60's accomplishing amazing feats of health and accumulating wealth? What makes the difference? Honestly... You need get-up and go! How much energy you have all starts with how healthy your cells are, which helps determine how fast you age. This simply means if your cells are aging faster than your age... you're more likely to feel old and have less energy. So, whether you look or feel your actual age, or older than you want, you need CTFO's exclusive 10xPURE™ products, right now! At the same time, why not build a side-hustle career income? CLICK the Easy 3-Step Company Tour BUTTON BELOW Let me share a quick bit of health & wealth discovery you will want to know... Did you hear Kevin in video #1 of the Easy 3-Step Company Tour say that as President of his last company, they did over $1 billion in sales in 20 countries over 22 years? Wow, that's stability. This man is the rock. Join Kevin and the team at CTFO right now and you could be our next big health & wealth success story! Ever feel like you are capable of more... more performance at work, exercise, money or even in your personal life? Stop procrastinating. You heard Kevin, you can build a career income part time at CTFO. Just click the buttons below. It will just take a few minutes... remember, it's just a few short minutes.CTFO has the worldwide exclusive 10xPURE™ delivery technology which you will find in many of our top 10 products. No matter how good the quality of a product, without penetration and absorption of the key ingredients, you can end up with a wasteful application and reduced potency. It's not what you buy, it's what you get.All of our CBDa, CBGa and related CBD products are manufactured in the USA in a registered GMP facility. Our CBD is made from Non-GMO, Pesticide Free, CO2 Extracted Hemp Oil using only organic ingredients. GMP stands for "Good Manufacturing Practices" and refers to a system of manufacturing that guarantees reproducibility of product quality to set specifications. P.S. Remember, successful people make a habit of doing the things that other people just won't do.There are more than 400 phytonutrients that exist in hemp plants. Our extraction technology allows us to extract all of these nutrients, without using any heat or harmful solvents. The result is a whole food with exceptional nutrient qualities, and much more efficient skin care products. bhsales.vpweb.com --- Send in a voice message: https://anchor.fm/bhsales/message

In episode number 20 of the Podcast "International Pharma Talks by ELS Solutions" our host, Dr.Diogo Sousa-Martis, Ph.D., MBA, will focus on “Good Manufacturing Practices and Quality Assurance ”. In this podcast, we will cover the topic of Good Manufacturing Practices and Quality Assurance in LATAM, to broaden your perspective on GMPs, Quality Assurance and the best business advice in LATAM so you can make better informed decisions.

Victor Hoerst is ASRS Sales & Concept Design at Stoecklin Logistics, Inc. For 80 years, the Swiss Stoecklin Group has offered innovative logistic solutions. Optimization of space, time, and resources is their contribution to your success. As a prime contractor with overall responsibility, Stoecklin Logistics offers complete, ready-to-use systems allowing you to store your products in minimum space, manage them reliably and pick up and transport them as quickly as possible with minimum personnel costs. Highlights Looking to build something new - 3:39 Investing in automation - 8:22 The first thing that they do - 11:30 The economy is a scale - 13:40 Taller buildings - 22:16 Trusting in automation - 29:23 Having experience with Good Manufacturing Practices - 29:05 Not overbuilding the system - 34:04 Thinking more strategically - 45:00 Consider automation when you're building something new - 48:35 Episode Resources Connect with Justin Smith https://smithcre.com/ https://www.lee-associates.com/ JBSmith@LeeIrvine.com https://www.linkedin.com/in/justinbsmith Connect with Victor Hoerst of Stoecklin https://www.linkedin.com/in/vichoerst 

BofC Live is the daily news and interview program of Business of Cannabis. Business of Cannabis highlights the companies, brands, people and trends driving the sector. On this episode of BofC Live, we connect with Ashton Abrahams, the President of Sigma Analytical Services – a cannabis testing lab in Canada. Recently, Sigma Analytical Services was granted Good Manufacturing Practices certification from the Australian Therapeutic Goods Administration. Business of Cannabis connected with Abrahams to talk about what this certification meant for Sigma Analytical Services specifically, and Canadian cannabis more generally.Learn more about Sigma Analytical Services.

In This Episode... We're discussing GMPs (Good Manufacturing Practices). What are they? How are they useful for importers with suppliers abroad in countries like China? What is their relation to controlling your suppliers in comparison to activities like quality audits, social compliance audits, and process audits? After listening to this episode, you'll have a grounding in what GMPs are and how to implement them yourself if you feel that they'll help you improve results from your suppliers. Show Notes 00:00 - What are GMPs? A brief explanation behind the concept. What are the basic things that must be done well and carefully when it comes to manufacturing? This is the basic idea of GMPs. They can vary based on industry and are often grounded in quality and safety. 03:18 - What industries (aside from food, medical, and pharmaceutical) are particularly benefited by using GMPs? More relevant for any product type which has high safety and/or quality requirements.  04:57 - Some similarities between GMPs and ISO 9001. GMPs may be insisted on when it comes to practical actions suppliers should focus on that an auditor will check on-site. This applies to the physical, whereas the opposite would be social compliance audits which focus very much on what people say, not necessarily what they physically do. 07:28 - Why focusing Asian suppliers on physical improvements is a good way to spur improvement. It's harder to fake - they either 'do something' better, or not. Costco is an example of a retailer who has a fairly simple GMP checklist that they ask their suppliers to follow for products which are not medical, etc. 09:14 - Are GMPs a part of the manufacturing agreement with a supplier? They may be, but can also be used during initial qualification of a potential supplier, too. Their improvement based on GMPs can be assessed over time and rewarded with more orders (or fewer). 10:24 - What list of principles might typically be included in GMPs? It will vary per industry, but for general consumer goods, it may include: How materials are stored. Segregation of conforming vs non-conforming material. Production equipment maintenance. Staff training and experience. During or after production checking schedule and method (includes sampling and testing equipment). Planning to avoid excess inventory.  Some buyers may have specific requirements based on their industry, too, in a subset of the GMP checklist. For example, checking the material purity and the molds would be key for producers of die-cast products. Any more specific and you go into the territory of process audits, but GMP checklists usually don't go that far. 16:15 - How GMPs are more superficial than process audits. GMPs are more generic, but they have a value in terms of making sure the basics are followed properly. 17:35 - Do suppliers keep records about following GMPs. Suppliers rarely admit to following GMPs, but it may happen in specific cases where GMPs are critical (such as from a safety perspective). 18:04 - What are the kinds of elements that make up the USFDA GMPs for medical devices? This gives an idea of the demands placed on suppliers of medical devices where safety is critical. Focus on documenting good manufacturing practices and quality system. This will include QC records, traceability information, preventive maintenance, images of the machinery and facility, how defective pieces are dealt with, BOM, pre-production verification records, and more. All of this goes into a technical file which is retained until required and can be updated when needed, also. For SMEs, following these GMPs would put you well above the average. 24:40 - Flexibility of GMPs for medical devices. The USFDA GMPs are purposefully flexible, as there will be a big difference in safety requirements and preventive thinking, for instance, between the production of a pacemaker and a head covering for hospital staff. 26:25 - Are such GMPs covered in ISO 13485 for medical devices? No, but a good auditor will consider them during the audit and ask questions about them. Also discussing how issues are minimized and tested for even after the product is on the market by reliability and quality engineers. 30:07 - What are food GMPs? No one standard, but a focus on hygiene is common. ISO 22001 food safety management system defines GMPs as 'prerequisites' as they are the basics that should be in place before foodstuffs are produced. They would include points like pest control, staff hygiene and controls on smoking, rubbish and waste disposal, correct water supply, and more which are specific to food production. Food GMPs often differ from one country to the next. 33:27 - GMPs' basis in common-sense. They are the basic things that no one can dispute need to happen. 34:15 - Wrapping up: How should buyers who want to implement GMPs get started? Think about your product categories. The approach will be different for general consumer goods in comparison to those that require advanced safety like food or pharmaceutical goods, for example.  List the basics that you need your manufacturers to do to a good standard. Will they be used in your ongoing re-auditing program for suppliers or with a management system audit? Consider your objectives and scope. If you're concerned mainly about how materials are handled and manufacturing is done, then implementing GMPs is appropriate, but if you need to go deeper into a supplier's capability then a quality system and/or social compliance audit may be relevant. Brainstorm and develop a checklist, organizing it by category. Audit based on the checklist and hone it over time. If you work over different product categories, the GMP checklist may need product-specific subsets added to it, too. Extra GMP information you may find helpful What Are Good Manufacturing Practices (GMPs)? Do Good Manufacturing Practices (GMP) Audits Drive Improvement? Understanding the Basics of Food GMP Food safety standards: ISO 22001, HACCP, GMP If you feel that you need help with auditing suppliers, Sofeast provides a full spectrum of factory audits for you across Asia. Get in touch with us Connect with us on LinkedIn Send us a tweet @sofeast Prefer Facebook? Check us out on FB Contact us via Sofeast's contact page Get even more great content or assistance with your own project Visit our website at Sofeast.com  Subscribe to our YouTube channel Subscribe to the podcast  There are more episodes to come, so remember to subscribe! You can do so in your favorite podcast apps here: Apple Podcasts Spotify Stitcher Google Podcasts TuneIn Deezer iHeartRADIO

The rulemaking process in cannabis with Liz Mason and Tiffany Coleman. Liz is the Director of Operations at Aurum Labs, one of the first fully certified cannabis testing labs in Colorado. Liz Mason and her husband, Luke, started Aurum Labs back in 2014, both of their backgrounds and degrees are in chemistry, biochemistry, and molecular biology. In her time at Aurum she has helped to grow the business substantially, expanding it into the nationwide hemp market and helping to increase the testing services offered by the lab. Liz Mason is the current Co-chair for the NCIA Hemp Committee and Founder of Aurum Services, the Hemp Division of Aurum Labs that caters testing services specifically to the hemp industry. Tiffany Coleman - Studied Chemistry at the University of Missouri Kansas City. Over 15 years with best practices in pharmaceuticals. Came to Cannabis to help keep patients and consumers safe by using those best practices and work towards standardized sampling and testing in the industry. Chair of the NCIA Scientific AC and founder of Cassin Consulting to help cannabis companies establish quality systems using Six Sigma and Good Manufacturing Practices. There’s a call to action for our listeners to get involved in the rulemaking process. Of course, NCIA files amicus briefs and submits comments to various government agencies as needed on the topic of cannabis and sometimes this gets really specific. Our guests explain more about what we’re doing in this case as well as break down the problem and the solution. We also talk about how they got into the cannabis business and why they think it was important to be a part of it.

The rulemaking process in cannabis with Liz Mason and Tiffany Coleman. Liz is the Director of Operations at Aurum Labs, one of the first fully certified cannabis testing labs in Colorado. Liz Mason and her husband, Luke, started Aurum Labs back in 2014, both of their backgrounds and degrees are in chemistry, biochemistry, and molecular biology. In her time at Aurum she has helped to grow the business substantially, expanding it into the nationwide hemp market and helping to increase the testing services offered by the lab. Liz Mason is the current Co-chair for the NCIA Hemp Committee and Founder of Aurum Services, the Hemp Division of Aurum Labs that caters testing services specifically to the hemp industry. Tiffany Coleman - Studied Chemistry at the University of Missouri Kansas City. Over 15 years with best practices in pharmaceuticals. Came to Cannabis to help keep patients and consumers safe by using those best practices and work towards standardized sampling and testing in the industry. Chair of the NCIA Scientific AC and founder of Cassin Consulting to help cannabis companies establish quality systems using Six Sigma and Good Manufacturing Practices. There’s a call to action for our listeners to get involved in the rulemaking process. Of course, NCIA files amicus briefs and submits comments to various government agencies as needed on the topic of cannabis and sometimes this gets really specific. Our guests explain more about what we’re doing in this case as well as break down the problem and the solution. We also talk about how they got into the cannabis business and why they think it was important to be a part of it.

Bob Gravani is Professor Emeritus of food science and Director Emeritus of the National Good Agricultural Practices Program at Cornell University. There's he's been actively engaged in extension and outreach, teaching, and research activities. His food safety career spans 40 years and includes work with all sectors of the food system. He has developed innovative programs for constituents in production agriculture, food processing, food retailing, and foodservice, as well as for regulatory agencies and consumers. Bob earned his bachelor's degree in food science from Rutgers University as well as his master's and Ph.D. degrees in food science from Cornell University. He is a Past President of the International Association for Food Protection (IAFP) and is an IAFP Fellow. In this episode of Food Safety Matters, we speak to Bob [16:30] about: His work with the New York State Department of Agriculture and Markets How research, science, and technology have changed the food safety arena How the idea of food safety has evolved over the years Challenges related to making sure people who work in the food industry understand the impact of their jobs Good Manufacturing Practices and how not following them can lead to food system failures The concept of being unconsciously competent The importance of new training techniques, adult education, and behavioral science Why food safety culture is such a poorly understood concept Programs implemented for food science majors​ News Mentioned in This Episode FDA Halts Production at Sprouts and Soy Processing Facility for Failing to Comply with Produce Safety Rule under FSMA  [4:14] Egg Product Inspection Regulations Get First Update in 50 Years | Final Rule Pre-publication [8:47]  FSIS to Host Virtual Public Meeting on the Future of Consumer Food Safety Education [11:46]    Food Safety Education Month Resources  ServSafe - FoodSafetyFocus.com  FoodSafety.gov  Clean, Separate, Cook, Chill  Food Safety Education Resources for Families  Ask USDA (formerly Ask Karen)  CDC Food Safety Education Month Resources Keep Up with Food Safety Magazine Follow Us on Twitter @FoodSafetyMag and on Facebook  Subscribe to our magazine and our biweekly eNewsletter We Want to Hear From You! Please share your comments, questions, and suggestions. Tell us about yourself—we'd love to hear about your food safety challenges and successes. We want to get to know you! Here are a few ways to be in touch with us. Email us at podcast@foodsafetymagazine.com Record a voice memo on your phone and email it to us at podcast@foodsafetymagazine.com

Good manufacturing practices , components of good manufacturing practices --- Send in a voice message: https://anchor.fm/psbtrainingacademy/message

interviewed head scientist at the kratom testing lab What Is Kratom Lab Testing? Like with all botanical products, it is possible to run Kratom through a series of lab tests at an accredited kratom testing laboratory to ensure that the powder is what the supplier says that it is. In the case of Kratom lab testing at, www.ucgardnercenter.com , the testing is usually done to ensure all of the following: • Identity, i.e. that the plant material is actually Kratom • No pathogens or other contaminants present • Sample does not contain high levels of heavy metals • Kratom isn’t mixed with an undisclosed substance • Amount of common alkaloids, mitragynine, and 7-hydroxymitragynine • Kratom Alkaloids are real   For most commercially available Kratom, the amount of mitragynine present is not typically more than 2%. There is usually even less 7-hydroxymitragynine in any botanical substance unless it has been processed further into a tincture or kratom extract. As far as pathogens, it is possible that Kratom that is not processed safely by the growers could contain the following: • Coliforms • Salmonella • Mold or yeast   Finally, the following heavy metals should be tested for in Kratom products: • Arsenic • Lead • Mercury • Cadmium • Nickel   When a Kratom vendor tests their supply in a independent lab, they are typically testing for pathogens, metals, and compound alkaloid content to ensure that their customers will only be sold high-quality Kratom that is not dangerous to use. Why Is Kratom Lab Testing Important? The biggest reason that Kratom lab testing is important is to ensure both the safety and the quality of the product that is being sold to Kratom consumers. Contaminated Kratom can cause illnesses such as a Staph or Salmonella infection, and both of these conditions can be dangerous if not treated properly. If a Kratom user gets sick from their Kratom, they might not even know that either of these infections is a risk to them! For that reason according to www.bio2008.org,  it’s very important that kratom vendors do their due diligence and have their supplies regularly tested for quality and safety purposes. Without kratom testing, they could be accidentally giving their customers an adulterated or contaminated product. Testing is always important when consumables are being sold, and that truth is no different when it comes to Kratom. Advocating For Safety Testing Another reason that it is very important to test Kratom for safety is to help dispel many of the misunderstandings and misconceptions about Bali Kratom consumption that are commonly spread. Kratom powder consumption, as reported at www.rosypress.com, is currently a grey zone in terms of its legality. While kratom has not been banned in most places, it is also not regulated in most places. Instead, Kratom powder waits somewhere in the middle. And all it takes is one bad batch of Borneo Kratom for it to be ruled illegal and dangerous. As a Kratom capsules vendor, it is part of our responsibility to the community to help prove that Kratom capsules can be safe when used and vetted properly. Like anything that you eat, it can be dangerous if the supplier was not honest about its source. For that reason, according to this article on www.as1effect.com,  it is incredibly important to test Kratom products. Having solid testing proof about the composition and safety of Kratom products posted at www.dynamicexperiencesgroup.com  – in the form of Certificates of Analysis from accredited labs – will help to advocate for its regulation as a safe and beneficial immune boosting supplement. Any vendor that sells a green malay kratom product without testing is putting both their customers and the entire Kratom community at risk due to bad products. How To Know If Lab Testing Was Done Now we’ve come to another difficult part of understanding what goes into lab testing Kratom: how do you know that the testing was completed? First, you’ll need to check the website of the vendor in question. Because there are not yet any widespread systems of proving whether a kratom vendor tests their product or not, you will need to a little bit of research on your own. Some kratom vendors have worked with the AKA – American Kratom Association – to show that they regularly test their product and have other Good Manufacturing Practices in place, and this may be noted on their website by a seal that they are GMP Qualified. If you do not see evidence of lab testing on a kratom company’s website or marketing materials, ask for Certificates of Analysis. Any reputable kratom vendor should be willing to provide you with this document that guarantees lab testing and quality assurance. Without the legitimate proof demonstrated by Certificates of Analysis, it will be up to you to do the investigative legwork and decide whether or not you believe kratom vendor claims that they tested a product.   This interview should help consumers find kratom that has been tested through an independent third-party audit, that we follow all of the standards listed on www.vacfacts.info/hollistic-doctors-killed.html , for both processing and manufacturing Kratom to ensure our customers’ safety. our final audit report which confirmed our status as GMP qualified here. We hope that today’s podcast episode has helped you to get a more complete understanding of what it is that we mean when we say that we are dedicated to lab testing our kratom products to ensure that you are getting the highest quality Kratom that we can possibly offer to you at this time.

Dr. David Galvez is a Chief Scientific Officer and strategic leader focused on bringing high standards of Quality and Compliance, Good Manufacturing Practices and Specialized Services to the Canadian Cannabis and Hemp industries. Dr. Galvez completed his doctorate in Plant Physiology at the University of Alberta, Canada, and served as formulator and Director of Research and Development of botanical products. He is also the Chief Scientific Officer of LotusTopia, a California-based canine wellness company focused on bringing the benefits of cannabinoids to dogs and their humans.  Dr. David Galvez, Chief Scientific Officer and strategic planner in the Canadian Cannabis and Hemp industries to discuss what is happening North of the border and what are the things American hemp growers can learn from the mistakes and successes of our neighbors. Let’s discuss why he thinks vertical integration is a sure path for disaster, the emergence of specialized, niche services and products and why 2020 will be all about staying close to your core competencies.   

Many consumers quickly glance at the label on a dietary supplement, blindly purchase it, and never question where it was made or if what’s listed on the label is actually in the bottle. But what if you don’t even know what you’re buying? Has the product been tested to meet label claims, where is it manufactured, and how pure really is it? Regardless of the myths that surround the supplement industry of ‘not being regulated by the FDA’, this news story will change your mind. Because this one involves a serious indictment after plenty of warning letters, strikes, and failed audits. FDA indicts major contract manufacturer in ABH Pharma After years of playing “whack-a-mole” by sending warning letters to small brands, the FDA — and now the Department of Justice — have gone after the root of the supplement industry's biggest problem: underhanded contract manufacturers. These are the companies that are actually bottling the products, and we have long stated that they are a better “pinch point” for strict enforcement of current Good Manufacturing Practices. On January 17th, 2020, a major contract supplement manufacturer under the names of ABH Pharma, ABH Nature’s Products, and Stocknutra.com published a press release on BusinessWire issuing a nationwide recall on all lots of dietary supplements manufactured and sold between January 2013 – November 2019, after an indictment was posted in New York on December 26, 2019. Major offenses over several years The DOJ indictment, which names Mohammed Jahirul Islam (“Islam”) as the owner of the three companies, alleges that their facilities distributed adulterated and misbranded dietary supplements and unapproved and misbranded drugs. They signed a consent decree forcing Islam to destroy all dietary supplements (and drugs) in their possession within 15 days, which has now also been posted on the FDA's website. The DOJ indictment report stated that ABH failed 6 FDA audits over the years, had warning letters dating back to 2012, and neglected to conduct at least one appropriate test for ingredient identity. The indictment itself (which is linked at the bottom of the DOJ's report web page) includes new infractions from a November 2018 inspection. Such infractions include some egregious drug claims made on products they manufactured, such as “Whey protein in the form of protein powder can help in reducing the symptoms associated with anxiety and depression”. In addition, ABH Nature's products had a voluntary recall in June 2017 and January 2018 due to possible salmonella contamination. “As demonstrated by the consent decree, this Office and the FDA will work tirelessly to protect consumers who take dietary supplements, ensuring that manufacturers comply with good manufacturing practices and do not distribute unapproved and misbranded drugs in violation of the Food, Drug, and Cosmetic Act.” — Richard P. Donoghue, U.S. Attorney for the Eastern District of New York A long time coming The indictment lists several inspections at the Defendants' Edgewood, NY facility, including inspections that occurred in or about July 2012, May 2013, August 2013, November 2016, and February 2018, on top of the most recent November 2018 inspection. The FDA's warning letter from 2012 lists seven major cGMP (Current Good Manufacturing Practice) violations, such as adulteration, mislabeling, misbranding, failure to verify finished supplements, failure t... Read more on the PricePlow Blog

Everyone who sells or makes a supplement or food, or an ingredient, is subject to FDA requirements. By now, most folks in the FDA-regulated world know the minimum level of cGMPs (current Good Manufacturing Practices). It includes things like raw material testing, specifications, batch records and finished product testing.But how do you know when your manufacturer has gone from meeting the minimum basic GMPs to the next level—what we can call Excellent Manufacturing Practices, or EMPs? 

If your house is on fire, is it worth it to worry, about the fire-resistance rating of your living room sofa set? It might be, depending on which room the fire is burning and whether your escape route runs past the living room couch. This type of calculation now besets both the U.S. and Canadian vaping industries. In this episode of RegWatch hear how an alliance of vaping associations from north and south of the border are working to establish a unified set of standards for Good Manufacturing Practices, ready-made, for the U.S. Food and Drug Administration and Health Canada to embrace. Could manufacturing standards that are fit for purpose, help douse the cross-border fire which currently engulfs vaping? Find out! Only on RegWatch, by RegulatorWatch.com. Produced by: Brent Stafford Released: August 17, 2019

Welcome to The Chronically Human Podcast Ep. 36 Our guest today is Dr. Peter Grinspoon. He is a primary care doctor in Boston, teaches at Harvard Medical School, is the author of “Free Refills”, a book detailing his addiction and recovery with pain pills, and he is an advocate for legalizing and utilizing Cannabis as Medicine. (At the 38 minute mark we had an issue with the audio. There is an echo or reverb when Dr. Grinspoon speaks. I apologize for this. We’ve left that portion of the conversation in because it's full of great information even though the audio isn't perfect) We have a great discussion about his unique perspective on the perceived opioid crisis, his take on how the government’s response to reducing opioid overdose deaths has negatively impacted people in chronic pain, and his work advocating for the use of Medical Cannabis. He explains why the current "Reefer Madness" proponents are wrong and exposes who the institutional forces are that are working to keep Cannabis illegal. We also talk about his father Dr. Lester Grinspoon and his pionnering work advocating for Cannabis and psychedelics. https://www.petergrinspoon.com Dr. Peter Grinspoon's Book "Free Refills" https://www.amazon.com/Free-Refills-Doctor-Confronts-Addiction-ebook/dp/B00Z7J7BEM You can find Peter's artciles on The Opioid Crisis, Medical Cannabis and Health and Wellness at the Harvard Medical School's Blog https://www.health.harvard.edu/blog/author/pgrinspoon Follow Peter on Twitter: @Peter_Grinspoon Peter is an active member of "Doctors For Cannabis Regulation" which is an organziation of Doctors who are working to legalize Cannabis and educate other healthcare professionals about using Cannabis as medicine. https://dfcr.org I exercise my health freedom by consuming Kratom. I’ve been in chronic pain for over 30 years and I now use Kratom and CBD oil to help improve my pain and allow me to live a fuller more productive life. The only brand of Kratom I trust is Urban Ice Organics. They test their Kratom, they utilize Good Manufacturing Practices, they stand behind their product, they are active in keeping Kratom legal and they fund vital Kratom research. https://naturalorganix.com Use the promo code “ChronicallyHuman20” at checkout to get 20 percent off your next order. If you'd like to hear more about my experience with Kratom email me brad@chronicallyhuman.co Please consider supporting the show by subscribing and sharing this episode with friends and family. I apologize for the quality of the audio in the last 20 minutes. The Skype connection went in and out and we weren’t aware of the reverb/echo issue until we re-listened to the conversation. I wasn’t able to fix it. I decided to leave it in even with the audio issue because Peter provided a lot of great information. I understand audio quality is important and we strive to do our best to present useful information in the best possible way. Check out our Youtube Channel where you can see the video version of the podcast.&nbs

Carmen Alexe CHPodcast Ep 33 “How to find Freedom in an unfree world” Thanks for joining us today. My name is Brad Miller and this is the Chronically Human Podcast where we have conversations aimed at creating a better world with more individual freedom and less unnecessary suffering. Our guest today is Carmen Alexe - we talk about her courageous escape from Romania during the Cold War, what it was like to live in Communist State, and her take on the rise of socialism in America and why she thinks that’s an extremely bad idea. She has a great website called SolitaryGal.com where she explains how you too can find more freedom in an increasingly unfree world. http://solitarygal.com/index.html I exercise my health freedom by taking Kratom. I’ve been in chronic pain for over thirty years and I wanted to find an alternative to the traditional pain management system. For me Kratom works. The only Kratom I trust comes form Urban Ice Organics - you can find it here at https://naturalorganix.com They test have all their products third party tested, they are a pioneer with using Good Manufacturing Practices and are committed to keeping Kratom legal for us all. If you’d like to learn more about Urban Ice Organics you can watch Kelly Dunn on The Chronically Human Podcast Ep. 25 on Youtube, iTunes, and Spotify. https://www.youtube.com/watch?v=AOn-rJeqq0I Please support the show by subscribing to our Youtube channel, on iTunes, Spotify and Stitcher. Also leave a five star review if you enjoy our content. We will be doing an Urban Ice Organics giveaway in May. We’ll announce details soon on our Instagram page @chronicallyhumanpodcast and on our Youtube page. I really enjoyed my conversation who is optimistic, full of life and about finding positive solutions that individuals can implement to find more freedom in an increasingly unfree world. Carmen’s great blog post about socialism, censorship and propaganda. http://solitarygal.com/libertarian-thoughts/the-road-to-socialism-requires-censorship-and-propaganda What Americans don’t understand about Freedom https://fee.org/articles/i-grew-up-in-a-communist-system-here-s-what-americans-don-t-understand-about-freedom/

The Future Element for the Current Good Manufacturing Practices to Prevent Forms 483 by Edgar Fernandez

Kelly Dunn is the owner of Urban Ice Organics. It’s the fastest growing Kratom company in the country and for good reason. They lab test all of their products and they adhere to Good Manufacturing Practices. Urban Ice Organics is the only brand that I trust. https://naturalorganix.com We talk about the science and safety of Kratom, the current state of the Kratom industry and the personal reasons why he produced the documentary “A Leaf Of Faith”. Kelly discusses why he uses Kratom, the growing number of people who are using it to improve their health and wellbeing and why its important to keep Kratom legal. Kelly is doing a lot to keep Kratom legal and to find out the truth about it. He supports the Scientific Research on Kratom by the University of Florida and he’s working on a sequel to “A Leaf of Faith". I firmly believe that the documentary "A Leaf Of Faith" played a huge role in helping to keep Kratom Legal. You can check out A Leaf of Faith on Netflix, you can purchase a DVD of the documentary or watch it on iTunes. https://itunes.apple.com/us/movie/a-leaf-of-faith/id1367790093 You can follow them on Twitter @UI_Organics @Leaf_Of_Faith On Instagram @ui_organics On Facebook https://www.facebook.com/UIOrganics/ During our conversation we also spoke about the work that The American Kratom Association is doing to keep Kratom Legal. Their site is a great way to learn more about Kratom. If you already use Kratom and it helps you please considering supportering their work. https://www.americankratom.org I found Urban Ice Organics after more than a year of research on Kratom. I made my final decision to try their brand after watching Chris Bell, the Director of “A Leaf of Faith” discuss and share Kratom with Joe Rogan, on his podcast back in 2016 and I’m glad I did. It’s had a very positive effect on my life. Neither of us are doctors and our conversation shouldn’t be construed as medical advice. Personally, I use Urban Ice Organics Kratom everyday to help manage my chronic pain. If you choose to take Kratom I recommend buying Urban Ice Organics. You can find their Kratom in capsule or loose powder form at https://naturalorganix.com Use the promo code: ChronicallyHuman20 to get 20% off your next order. Let us know what your thoughts about Kratom. You can leave guest suggestions, questions or comments about the podcast here: brad@chronicallyhuman.co We are always happy to connect with Free People of Goodwill. Thanks for Listening. Please support the show by subscribing, sharing and leaving a five star reviews. Brad Miller The Chronically Human Podcast

In Talking Precision Medicine podcast we sit down with experts on the application of AI and big data analytics in the drug discovery space. Our guests are innovators, business decision makers and thought leaders at the intersection of data and therapeutics. We discuss the promise, practice, challenges, and myths of AI in precision medicine. This show is brought to you by Genialis, and Rafael, our CEO, is your host. Genialis is focused on data integration and predictive modeling of disease biology… to help accelerate the discovery and de-risk the development of novel therapeutics. Today we speak with Patrick Hanley. Patrick works at the Children’s National Hospital in Washington DC, where he serves as the director of Good Manufacturing Practices for Immunotherapy. He is also a co-founder and vice president at Mana Therapeutics — a cell therapy company harnessing our immune cells to combat cancer. He is an expert in designing and manufacturing cell therapies... and was once a fierce competitor on the Houston indoor soccer circuit. We talk about the leaps and bounds of progress in cell therapy, and the challenges—including discovery, manufacturing, and distribution—that lay ahead.

Patricia Atherton, Lead Auditor for Intertek's Business Assurance group, is our guest in this week's episode. Patricia discusses her experience in the food industry and the Good Manufacturing Practices that must be followed in the ever-changing, ever-high risk industry of food manufacturing. View for the FSSC 22000 Webinar at this link:Click Here

Michael Cramer is currently the senior director of food safety and quality assurance with Ajinomoto Windsor, Inc. The company was formed through various acquisitions (Multifoods, Specialty Brands, and Windsor Foods) and ultimately the purchase of Windsor Foods by Ajinomoto. He will celebrate his 25th year with the company in October 2018. Mike is an SQF practitioner, ASQ-certified quality auditor, and a preventive controls-qualified individual. CRC Press published Mike's book “Food Plant Sanitation: Design, Maintenance and Good Manufacturing Practices” (2nd Edition, 2013). Mike is a graduate of West Chester University in West Chester, PA where he earned a B.Sc. Health Science in 1977. He spent 16 years working with Swift & Company (Armour, Swift – Eckrich, ConAgra) in poultry operations, processed meats and poultry, and corporate food safety and quality assurance. Finally, Mike has been an esteemed member of Food Safety Magazine's Editorial Advisory Board since 2001.   In this episode of Food Safety Matters, we speak to Mike Cramer about: Why Listeria continues to be a challenge in food plants Qualities that a food facility—and its staff—should have in order to tackle Listeria and environmental monitoring issues The financial burden of setting up an environmental monitoring program, and why it's necessary Implementing a program that is designed to look for Listeria spp., not just Listeria monocytogenes What happens when regulatory inspectors come in to conduct swabbing The pros and cons of testing in an in-house lab vs. a third-party lab Testing methodologies: cultural method, polymerase chain reaction, VIDAS, lateral flow devices, etc. What should happen when positive test results are confirmed The Ishikawa process and how it relates to getting to the root cause of environmental problems The importance of having a cross-functional team in place to attack Listeria harborage from all angles and departments Implementing chemical and mechanical actions to rid a plant of biofilm How the dirtiest areas of a food facility don't automatically equal Listeria contamination Sanitary design and hygienic design Quat, peroxyacetic acid, chlorine dioxide, silver dihydrous chloride, and other options for sanitizing Taking advantage of industry conferences, events, and new technologies to hone in on what a particular food business needs to know to improve food safety operations Related Content and Resources: BOOK: Food Plant Sanitation: Design, Maintenance, and Good Manufacturing Practices, 2nd Edition  2014 Sanitary Equipment Design Taskforce (checklist and glossary)  Risks of Oligodynamic Silver Use in Food Preservation and Processing Operations (June/July 2017) Mike Cramer's Articles Published in Food Safety Magazine: Environmental Listeria Monitoring: Seek and Destroy Pathogens (December 2017/January 2018) Allergen Management: A Personal and Professional Perspective (August/September 2016) A Look at GMPs: How FSMA Will Change Expectations (February/March 2016) Supplier Certification: A Matter of Risk Assessment and Resources (October/November 2015) Upgrade Sanitation Plan to Work Out Bugs (April/May 2014) For more articles from Mike Cramer, access our compiled search FoodSafetyMagazine.com Bob Ferguson's Food Safety Insights Articles: The Uphill Path to FSMA Compliance (October/November 2018) Lessons Learned: Careers in Food Safety (August/September 2018) Listeria: An Important Focus of Environmental Monitoring (June/July 2018) Sanitation Verification for Allergen Control (April/May 2018) Testing and Sanitation for Allergen Control (February/March 2018)  Outsourcing: Pathogen Testing under the Microscope (December 2017/January 2018) The New Face of Sanitation Programs: New Rules, New Challenges (October/November 2017) A Closer Look at Environmental Monitoring in the Processing Plant (August/September 2017) What Industry and FDA Are Thinking About FSMA Implementation (June/July 2017) The Drivers of Differences in Food Safety Testing Practices (April/May 2017) A Look at the Microbiology Testing Market (February/March 2017) News Mentioned in This Episode: Ostroff Retiring from FDA; Walmart's Yiannas Moving to Agency  Plant at Center of Largest Ever Salmonella Ground Beef Recall Accused of "Inhumane" Animal Treatment in USDA FSIS Records (Notice of Intended Enforcement, Notice of Deferral)  Nearly 7 Million Pounds of Raw Ground Beef Recalled After Salmonella Outbreak Presenting Sponsor: Eurofins Training Courses: Register and browse online for a training course near you Webinar: Is Your EMP Program Hitting the Mark? Watch our recorded webinar White Paper: Download Eurofins' Environmental Monitoring Guide Keep Up with Food Safety Magazine Follow Us on Twitter @FoodSafetyMag, and on Facebook  Subscribe to our magazine, and our bi-weekly eNewsletter We Want to Hear From You! Please share your comments, questions, and suggestions. Tell us about yourself—we'd love to hear about your food safety challenges and successes. We want to get to you know you! Here are a few ways to be in touch with us. Email us at podcast@foodsafetymagazine.com Record a voice memo on your phone and email it to us at podcast@foodsafetymagazine.com Leave us a voicemail at 747.231.6730  

Today we are joined by Dr. Loren Bertocci, a biochemist and one of the foremost experts in mitochondrial research as well as the Director of Science at Pangea Biomedical, a company he founded to make high quality supplements for the Masters athlete. He holds an AB in Human Biology from Stanford, a PhD in Physiology from Washington State, and a post-doctoral fellowship in Advanced Radiological Physics from University of Texas Southwestern Medical Center. His special area of expertise is the biochemistry of skeletal muscle and exercise, where he conducts research to identify and characterize atomic-level triggers for mitochondrial biogenesis.   Dr. Bertocci is also an accomplished weightlifter, having won a Bronze Medal in Olympic Weightlifting at the 2015 Pan Am Masters Championships and currently training to compete at the World Weightlifting Championships in the 65+ category. He also has an athletic background in swimming, water polo, triathlon and track.   Proper training, nutrition, and recovery are the cornerstones of progress, but supplements can help optimize your gains, especially if you are an athlete. The Masters population has special supplemental needs, as various metabolic and muscle building processes begin to slow with age. Dr. Bertocci helps us understand the essential supplements for the "athlete of aging."   Here is some additional information about the supplements mentioned in the show by Dr. Bertocci:   Tell us about your company. I started and own Pangea Biomedical. Its purpose is to produce dietary supplements with a product line targeted at active adults aged 40+. We currently have one product called Origins. Its primary characteristics and features include: Some limited anti-inflammatory effects; Some limited effect at attenuating post-exercise muscle damage; Stimulation of the growth of new mitochondria. Most people notice this as a “gee, doing x for this long a duration is easier than it used to be” kind of effect; Generalized anti-aging; Its effects are noticed proportional to two things; (1) the age of the person taking it and (2) the training intensity of the person taking it.   We have two other complimentary products ready to release once we get Origins up to enough profitability to be able to launch these next two products.   Do you recommend masters supplement with vitamins? Minerals? Things to look for, stay away from.   I am a strong supporter of dietary supplements for masters-aged athletes. There are three major reasons for this: Market pressures on modern agriculture have resulted in crops with lower levels of minerals, complex oils, and proteins than in ages past. Thus, regardless of how good your diet might be, it is increasingly difficult to have all you need in your diet; With aging comes an unavoidable reduction in daily metabolic output. In order to eat enough even very good foods to satisfy your real mineral/oil/protein needs, your caloric input would be so large that you would likely gain weight; Also with aging comes some decreasing capacity to absorb some of the complex molecules you do actually ingest.   The vitamins and minerals that, for most masters-aged athletes, might be most in need of supplementation are: Vitamin C (ascorbate) because of its role in the ascorbate-glutathione oxidation- reduction cycle; Selenium (the mineral in the center of glutathione); Calcium and phosphorus (bone minerals); Zinc (an important metal ion in the middle of some important metabolic enzymes); Vitamin D (for anyone who lives a largely indoor lifestyle).   My current dietary regime is representative of what I would recommend for any active masters athlete: An “age-specific” multi-vitamin (I happen to take Centrum Silver); Origins with a dose of 4 capsules 2x daily; An additional 2,000U of vitamin D if you are not normally exposed to a lot of sunlight.   Other: There is an enormous amount of data supporting the use of creatine as a supplement. I personally do not take it because I think my daily protein consumption is sufficiently high that I already consume plenty of its amino-acid precursors. I mention this not only to support it as possibly useful but also to warn against contamination by β-quanadino- propionic acid (aka β-GPA). This molecule is a competitive inhibitor of creatine kinase, the very enzyme required to convert phosphocreatine to free creatine and in the process make ATP. It is not at all uncommon to find β–GPA in the creatine you can purchase.     What supplements do you recommend based on good science? Obviously creatine – this is addressed above. Beyond that, the following molecules are supported by the largest number of publications in top-level journals (in no particular order): Resveratrol – this is the closest thing to a magic molecule there is. Its value was originally elucidated as a result of the famous French Wine Paradox study. Its health benefits are numerous; Quercetin – this is almost as effective as resveratrol; Pyrroloquinoline quinone (aka PQQ); Pterostilbene – a naturally occurring derivative of resveratrol with similarly broad beneficial effects; Ubiquinol – essential but for a somewhat more specific audience – those of us who take statins for hypercholesterolemia; Acetyl-L-carnitine;   Others that might be useful: BCAAs – leucine is required for activated mTOR gene to begin transcription, so an adequate amount of leucine in the diet will allow for the strength training adaptation to proceed maximally. All three of them can lead to the production of succinyl-CoA to anaplerose the citric acid cycle. This will have the effect of allowing acute responses to endurance-type exercise to (also) proceed maximally; HMB – this is a product of leucine catabolism and has been implicated in several pathways related to muscle protein synthesis. However, insofar as it is a product of leucine catabolism, it is not clear to me that it has any additional value if you already have enough leucine; A combination of curcumin and black pepper extract – there is a lot of (at least) decent evidence that this combination is an effective anti-inflammatory agent.   What do think about protein intake and the older athlete? I would say this is a minimum. I consume at least 2g protein per day per lb body weight. Aside from the negatives resulting from possible protein-related fat load, there is no real reason to limit this. If you consume more than you need, you merely deaminate the amino acids and use the carbon skeleton (directly) as a CHO or indirectly to store the C-C bonds as fat.   Should Masters stay away from many supplements? Unfounded claims etc. wasted money and junk?   Generally speaking, there is not much benefit to consuming anything other than what we have addressed already. For the most part, all you do with most supplements is functionally make expensive urine.   Aside from the waste of making expensive urine, there are several factors to consider as you stroll down the aisles at your neighborhood (or online) supplement store:   In most cases, there is no guarantee that the ingredients on the label actually provide nutritional value. In most cases, the people making these kinds of ingredient decisions are not sufficiently knowledgeable about the underlying science for their ingredient decisions to be trusted. The only way to avoid this problem is to assess the qualifications of the scientist(s) making the ingredient decisions. For most non- scientists, this is difficult if not impossible; There is no guarantee that what is on the label is actually in the container. Currently, in the USA, nutritional supplements are not subject any regulatory oversight; Similarly, and for the same reason(s), even if what is on the label is actually in the container, there is no guarantee that there are no possibly harmful and/or illegal contaminants; The only way to avoid the latter two problems is to only consume products with some sort of external certifications. The three most common certification processes are: USP – a pharmaceutical product produced by a company the follows the “U.S. Pharmacopoeia” standards set up by the FDA. Mostly, this is designed to ensure efficacy in comparison to existing and similar drugs. It does not apply to nutritional supplements. This is the kind of certification common to things like prescription drugs; GMP – a product produced by a company that follows the “Good Manufacturing Practices” set up by the FDA. Mostly, this is designed to make sure that the end product is not contaminated. This is the kind of certification common to things like multi-vitamins; BSCG – a product produced by a company that subjects its products to testing by the Banned Substance Control Group. A BSCG certification means the product has exactly what is on the label (or if proprietary, what it is supposed to have), does NOT have what is NOT on the label, and (perhaps most importantly) contains nothing that would trigger a positive USADA test. It is this certification that should be considered to be the “gold standard” for any nutritional supplement you consume. Unfortunately, the vast majority of nutritional supplements are not BSCG certified.   How can people get in contact with you? Email: labertocci@pangeamasters.coM Via our Pangea web site: https://www.pangeabiomedical.com/ > Visit our Pangea FB page: https://www.facebook.com/pangeabiomedical/

Suchil and Sam Coffman discuss a couple of concepts around FDA GMP regulations as well as the Apothecarist course at Herbal Medics University (aka The Human Path).  This episode is brought to you by Herbal Medics University.  Herbal Medics University is a branch of The Human Path.  The Human Path is a survival school that is focused around the survival of our human species.  Their classes are sustainability and earth-centric, yet also very practical and realistic.  They are structured similar to a university, in that they have core paths as well as electives (aka “peripheral classes”).  All of their courses are focused on self-sustainability, and the subjects that fit into that focus span a very wide range as well as amazing depth in each subject. You can visit them at HerbalMedics.University Thanks for listening! 

Michael Cramer is currently the senior director of food safety and quality assurance with Ajinomoto Windsor, Inc. The company was formed through various acquisitions (Multifoods, Specialty Brands, and Windsor Foods) and ultimately the purchase of Windsor Foods by Ajinomoto. He will celebrate his 25th year with the company in October 2018. Mike is an SQF practitioner, ASQ-certified quality auditor, and a preventive controls-qualified individual. CRC Press published Mike's book “Food Plant Sanitation: Design, Maintenance and Good Manufacturing Practices” (2nd Edition, 2013). Mike is a graduate of West Chester University in West Chester, PA where he earned a B.Sc. Health Science in 1977. He spent 16 years working with Swift & Company (Armour, Swift – Eckrich, ConAgra) in poultry operations, processed meats and poultry, and corporate food safety and quality assurance. Finally, Mike has been an esteemed member of Food Safety Magazine's Editorial Advisory Board since 2001. In this episode of Food Safety Matters, we speak to Mike about: The characteristics of an effective sanitation program Balancing cost-savings while implementing an effective sanitation program The importance of the sanitation team within a food facility His experience with testing for allergen cross-contamination from the lunch room to the plant floor Plans for the third edition of his popular sanitation book What he thinks is the biggest sanitation challenge in food plants today The real reason for allergen-related food recalls The success of his "Seek and Destroy" and "Monthly Facility Assessment" programs What happens at Ajinomoto Windsor when a positive Listeria monocytogenes sample is detected The seven steps of sanitation explained in detail The role of sanitors, including what they should and shouldn't do as part of their daily jobs The complexities of seemingly simple tasks in sanitation, such as vacuuming and floor sweeping His tips for equipment cleaning, including his preferences when it comes to pressure washing and water temperature  His thoughts on all-encompassing equipment checks vs. random spot checks The benefits of collecting microbiological swabs BEFORE applying sanitizer Standard tools that all sanitors need and use How to communicate with your chemical supplier to get the tools and resources you need for an effective sanitation program The use of UV light in sanitation Advice for anyone looking for new technology to improve food plant sanitation What can happen when sanitation is not approached correctly Related Content and Resources: BOOK: Food Plant Sanitation: Design, Maintenance, and Good Manufacturing Practices, 2nd Edition http://amzn.to/2FyaKzf Mike Cramer's Articles Published in Food Safety Magazine: Environmental Listeria Monitoring: Seek and Destroy Pathogens (December 2017/January 2018) http://bit.ly/2BkZyHc Allergen Management: A Personal and Professional Perspective (August/September 2016) http://bit.ly/AllergenMgmt A Look at GMPs: How FSMA Will Change Expectations (February/March 2016) http://ow.ly/Ye2od Supplier Certification: A Matter of Risk Assessment and Resources (October/November 2015) http://ow.ly/TIUsX Upgrade Sanitation Plan to Work Out Bugs (April/May 2014) http://bit.ly/1OdwCx7 For more articles from Mike Cramer? Access our compiled search FoodSafetyMagazine.com https://www.foodsafetymagazine.com/?Keywords=cramer&display=search&newSearch=true&noCache=1 News Mentioned in This Episode: New Pesticide Testing Data Touts U.S. Food Supply as "One of the Safest in the World" http://bit.ly/2F3OHQH  FDA Testing Fresh Herbs, Avocados for Foodborne Pathogens  http://bit.ly/2GMTNB8 Ready-to-Eat Processed Meat: Source of South Africa's Deadly Listeria Outbreak http://bit.ly/2H5gdOf Presenting Sponsor Hydrite Chemical http://bit.ly/Hydrite Download this sanitation case study from Hydrite  Case Study: Improving Environmental Sanitation Results at a Pet Food Manufacturer  http://bit.ly/HydriteCaseStudy Share Your Feedback with Us Please feel free to share any questions, comments or even a suggestion on someone we should interview, let us know! There are two ways for podcast listeners to interact with us. Leave us a voicemail at 747-231-7630. Be sure to leave your contact information so we can get back in touch with you! Email us at podcast@foodsafetymagazine.com. 

The Rose Sheet’s editorial team discusses key news and developments over the past month, including cosmetics industry stakeholders’ efforts to tack cosmetics reform provisions onto pending US user-fee reauthorization legislation, continued tension in the EU regarding animal-testing policy under the Cosmetics Regulation and REACH, and dietary supplement firms’ ongoing struggle to comply with Good Manufacturing Practices requirements to FDA’s satisfaction.

What do the Red Hot Chili Peppers, Kanye West, Johnny Cash, The Black Crowes, Slayer, Jay Z, James Blake, Dixie Chicks, Tom Petty and the Heartbreakers, Black Sabbath, Slipknot, Metallica, AC/DC, Aerosmith, Weezer, Linkin Park, The Cult, Neil Diamond, The Avett Brothers, Adele, Mick Jagger, System of a Down, Rage Against the Machine, Audioslave, Sheryl Crow, ZZ Top, Lady Gaga, Shakira, Ed Sheeran, Damien Rice, Eminem, and just about every other world-famous band or musician you've ever heard of have in common? They were all produced by today's podcast guest: Rick Rubin, the American record producer and former co-president of Columbia Records.  In 2007, MTV called Rick "the most important producer of the last 20 years", and the same year he appeared on Time's 100 Most Influential People in the World list. Rapper Dr. Dre has stated that Rubin is, "hands down, the dopest producer ever that anyone would ever want to be, ever." But Rick has a personal passion outside of music that many people don't know about... ...health, nutrition, fitness and biohacking. And in this episode, in which Rick and I sit on his back porch, watching a relaxing sunset after a hard morning of Laird Hamilton's pool workout, we have an intense discussion about veganism vs. Paleo, Rick's weight loss journey, and much more. During our discussion, you'll discover: -The little-known Ayurvedic pulse taking technique Rick used to find out he need to "drink more bone broth"...[16:10] - Why Rick thinks an ice bath is very much like eating meat...[26:25] -How Rick lost 131 pounds by eating animal protein...[29:45] -Why Rick took an entire week to eat one steak...[28:56] -What legendary Ironman coach and physician Dr. Phil Maffetone told Rick to do for diet and exercise, and how Rick modified it...[37:35 & 41:05] -What a typical day is like for Rick...[54:25] -How Rick uses "transcendental meditation", and his insight into neurofeedback for the brain...[57:20] -Rick's unique dietary and supplementation routine he uses each day...[60:35] -The one herb Rick uses each day to decrease hunger and sugar cravings...[68:00] -Rick's standing workstation setup...[68:55] -Why Rick uses a projector instead of a television or computer to watch movies at night...[73:45 ] -The audio track that Rick falls asleep to each night...[76:30] -What is it that drives Rick to live the life he lives...[79:30] -And much more! Resources from this episode:  - - -Don Wildman's "" article from Esquire magazine -Phil Maffetone's "" - - -The full recipe for Rick's Stim-Stem Shake Espresso        Ice to desired texture - -The herb Rick uses to -The Rick uses under his standing workstation - - -The powder that Ben uses -Below is the Natural Calm Magnesium reply that Ben mentioned regarding heavy metals: In regards to the Arsenic levels that Labdoor has decided to use, it is from a proposed limit over 10 years that was NEVER approved or accepted. The current established level for Arsenic is 10mcg/day. Why Labdoor decided to use a never approved or accepted proposal in unclear. In regards to the Natural Calm supplement, here is Natural Vitality's official statement on it: "The simple truth is that Natural Calm both meets its potency label claim and is well within the No Significant Risk Levels for arsenic and in fact is less than 10 percent of California’s Prop 65 stringent safe threshold levels. This has been consistently scientifically validated by third party test results from top American testing labs as part of standard Good Manufacturing Practices. While testing results commissioned by Labdoor, when correctly interpreted, align perfectly with our results, their report contains a number of distortions which provide both a highly inaccurate picture and a disservice to consumers. We believe Labdoor is attempting to use our well-deserved, award-winning reputation to inflate their importance. Apparently their business model involves casting themselves as a “trusted source” by creating sensationalized stories to drive traffic to their website with the objective of creating profit from advertising sales and, interestingly, sales of supplements. Factual Flaws Labdoor’s Natural Calm test size was over two and a half times our recommended serving size but they did not factor that into their analysis. When correctly interpreted our results read: Magnesium was 346 mg, about a 1% variance from our label claim of 350 mg. Arsenic was .7992 of a microgram. Less than 8% of the California Prop 65 No Significant Risk safe threshold. Labdoor was approached regarding their misinterpretation of the results and asked to retract their press release, send out a corrected press release and update their website. However, Labdoor refused to admit wrong doing of any kind and continues to assert the virtue of their inaccurate position. At this point, both through the correct interpretation of the assay provided to us from Labdoor and our retest of the lot in question, Natural Calm has been clearly shown to be accurate both in terms of label claim and in following California’s Prop 65. The laboratory used by both Labdoor and Natural Vitality was the highly regarded Covance laboratories. Covance’s interpretation of test results (both Labdoors and ours) validates our position in terms of label claim and purity. Additional information is available at Natural Vitality customer service if desired (info@naturalvitality.com). Having cleared the record with scientific facts, we now consider this matter closed." I would be happy to provide you with the Certificate of Analysis that we had performed on an actual servings size instead of the 10.66g that Labdoor used, which is 2.5x our suggested serving size. -The you can use before bed at night for minerals  -The at DharmaSeed.com -  -  -  -The Ben recommends for muscle gain  -The Ben recommends for muscle gain -The  Ben recommends for muscle gain Do you have questions, comments or feedback for Rick or me? Leave your thoughts at  and one of us will reply!

Quality Management Systems in cannabis with Andrew Samann, Founder and CEO of Orion GMP Solutions. Orion is a pharmaceutical process engineering firm focusing on the implementation and auditing of internationally harmonized Good Manufacturing Practices and Quality Management Systems in the pharmaceutical, dietary supplement, cosmetic, and cannabis industries. Andrew serves on the Executive Committee of the ASTM International D37 Cannabis Standards Committee, where he is the chairman of the Quality Management Systems Committee.