Podcasts about cgmp

Why is it so important for both men and women to understand the physiology of sexual intimacy? In this eye-opening episode of The Hormone Genius Podcast, Jamie and Teresa are joined by Dr. Liz Jones, a leading pelvic floor physical therapist from Bismarck, ND, to unpack one of the most sacred, yet misunderstood, aspects of the human experience: sexual intimacy. Dr. Liz brings 20 years of expertise treating complex men's and women's pelvic health conditions at Jones Physical Therapy, the clinic she co-founded with her husband, Joe. Together they've helped countless patients find healing in areas often clouded by shame, fear, or misinformation. This episode dives into both female and male pelvic floor therapy, with a special emphasis on common but often overlooked concerns in men, including: Erectile dysfunction Varicoceles Internal and external hemorrhoids Chronic pelvic pain Pain or fear related to intimacy For many men, these conditions go unspoken and untreated, often leading to emotional and relational strain. Dr. Liz helps normalize these issues and provides practical, hope-filled insight into how pelvic floor therapy can restore function and confidence. She is one of the few physical therapists who treats internal hemorrhoids and has developed a reputation for tackling difficult cases with compassion and clinical excellence. Also covered in this episode: Why understanding the biological design of sexual intimacy can dismantle harmful myths How cultural portrayals of sex often create false expectations and deepen insecurities The spiritual battle around sexual intimacy—and why healing in this area is so deeply needed How understanding the sacredness of the body, especially the pelvic region, can transform your approach to love, marriage, and personal health Whether you're a man experiencing one of these pelvic health challenges, a woman longing for better understanding in your marriage, or someone seeking healing in this vulnerable area—this episode is for you. Dr. Liz Jones, a wife, mother of five, and fierce advocate for pelvic health, reminds us that intimacy is not just physical—it's spiritual, emotional, and deeply human. Find her at https://jonespt.com/ elizabeth@jonespt.com You'll walk away with: A better understanding of how the pelvic floor works—for both men and women Hope for healing, connection, and confidence Practical steps toward restoring intimacy and trust in your relationship Don't miss this powerful and necessary conversation. Listen, share, and help us spread truth and healing.

In this episode Dr. Shawn Tassone and Maddie discuss various topics related to women's health, including the impact of AI on medical practices, the debunking of health myths, the rise of health tech, and the importance of understanding study validity. They also touch on the ethics of health influencers and the credibility of health products in the market. Episode Highlights: Why AI is likely to replace certain medical specialties. Why misinformation in women's health is a significant concern. How health trends often lack scientific backing. Continuous glucose monitor trend How online claims about health products often outpace actual results. Why it's essential to critically evaluate health studies and their methodologies. Reasons consumers should be informed and skeptical of health claims. Why fear-based marketing is prevalent in health products. Not all health influencers are credible; many promote products for profit. Why if a health claim sounds too good to be true, it probably is. Episode Resources: Dr. Shawn Tassone's Practice | https://www.drshawntassone.com Dr. Shawn Tassone's Book | The Hormone Balance Bible Dr. Shawn Tassone's Integrative Hormonal Mapping System | Hormone Archetype Quiz Thank you to our sponsor, Purality Health! The question isn't which supplements to take—it's whether your body can absorb them. Most traditional supplements fall victim to stomach acid before delivering benefits. Purality Health's micelle liposomal technology creates a double-layer protective system that shields nutrients from stomach acid destruction while facilitating direct bloodstream absorption—making supplements up to 800% more effective. For perimenopausal and menopausal patients, I recommend their Vitamin D3 with K2 for bone density and mood regulation, and their exceptional magnesium formula for sleep and muscle tension. As a physician, I value their commitment to quality: cGMP-compliant facilities, purity testing, and organic, non-GMO ingredients without unnecessary fillers. Visit puralityhealth.com/drshawn and use code DRSHAWN for exclusive savings. Medical Disclaimer This podcast and website represent the opinions of Dr. Shawn Tassone and his guests. The content here should not be taken as medical advice and is for informational purposes only. Because each person is so unique, please consult your health care professional for any medical questions.    

Do you have heavy periods, feel bloated, have headaches, bad PMS, or struggle with infertility and/or fibroids? Have you ever considered that these symptoms—and many more—could be related to a hormone imbalance? Estrogen dominance is one of the most commonly misunderstood hormone issues. In this episode, we take a deep dive into what estrogen dominance actually means. We explore the critical role of your liver and gut in estrogen detoxification and how dysfunction in these systems can lead to symptoms like heavy periods, breast tenderness, anxiety, fatigue, and stubborn weight gain. You'll learn how your liver goes through a two-phase detox process to neutralize estrogen, and how the gut's microbiome—including the estrobolome—can either help or hinder that elimination process. We also unpack a lesser-known but powerful enzyme called beta-glucuronidase, which can cause estrogen that was supposed to be excreted to be reabsorbed back into the body—essentially recycling hormones and contributing to estrogen dominance. This often happens when gut health is compromised due to dysbiosis, constipation, or poor diet. Whether you're in your reproductive years, navigating perimenopause, this episode will help you better understand the physiology behind estrogen dominance and how to begin addressing it at the root. We Heart Nutrition offers high-quality supplements designed specifically for women's health. Here are three standout features: Bioavailable Ingredients: Their supplements use the most absorbable forms of each nutrient, ensuring your body gets what it needs. Third-Party Tested: All products are tested for purity and potency, manufactured in NSF & cGMP certified facilities. Purpose-Driven: 10% of every purchase supports pregnancy care centers, aligning with their pro-life mission. Visit weheartnutrition.com and use code GENIUS for 20% off your first order. Medical disclaimer: The information presented in The Hormone Genius Podcast is for informational purposes only and is not intended to be a substitute for actual medical or mental health advice from a doctor, psychologist, or any other medical or mental health professional.

In this episode, Dr. Shawn Tassone discusses the nomination of Casey Means as Surgeon General, exploring her background, credentials, and the implications of her appointment. He critiques the healthcare system, the role of functional medicine, and the influence of nutrition on health. Dr. Tassone emphasizes the importance of questioning the narratives presented by health influencers and the potential impact of the Surgeon General's role on public health policy. Episode Highlights The nomination of Casey Means Questions about her qualification Casey Means educational background Thoughts on her residency Why disillusionment in medicine is common, but quitting is controversial Why functional medicine practices are critiqued as potentially exploitative Reasons continuous glucose monitoring is viewed as a money-making scheme Evaluating Casey Means' statements which may lack evidence How the Surgeon General's role is often more symbolic than powerful Episode Resources: Dr. Shawn Tassone's Practice | https://www.drshawntassone.com Dr. Shawn Tassone's Book | The Hormone Balance Bible Dr. Shawn Tassone's Integrative Hormonal Mapping System | Hormone Archetype Quiz Thank you to our sponsor, Purality Health! The question isn't which supplements to take—it's whether your body can absorb them. Most traditional supplements fall victim to stomach acid before delivering benefits. Purality Health's micelle liposomal technology creates a double-layer protective system that shields nutrients from stomach acid destruction while facilitating direct bloodstream absorption—making supplements up to 800% more effective. For perimenopausal and menopausal patients, I recommend their Vitamin D3 with K2 for bone density and mood regulation, and their exceptional magnesium formula for sleep and muscle tension. As a physician, I value their commitment to quality: cGMP-compliant facilities, purity testing, and organic, non-GMO ingredients without unnecessary fillers. Visit puralityhealth.com/drshawn and use code DRSHAWN for exclusive savings. Thank you to our sponsor, Endurance Products Company! After over 25 years of practicing medicine, I'll be the first to tell you that not all supplements are created equal. But when I discovered Dihydroberberine SR, by Endurance Products Company, I was genuinely impressed.  It's highly bioavailable and outperforms standard berberine at significantly lower doses. You can explore their offerings at endur.com. Not only is the science solid, but I love that Endurance Products Company is a family-run American company that has cared about doing things right since 1978. I've started recommending Dihydroberberine to my patients who struggle with blood sugar management, and the results speak for themselves. So much so, that I personally take this supplement for helping to support healthy blood sugar levels, heart health, and tap into how my body uses fats for energy As a special offer for my audience, Endurance Products Company is providing a 10% discount on your order! Simply use the code DRT10 at checkout when you visit endur.com. Medical Disclaimer This podcast and website represent the opinions of Dr. Shawn Tassone and his guests. The content here should not be taken as medical advice and is for informational purposes only. Because each person is so unique, please consult your health care professional for any medical questions.  

Today we're diving into how to source peptides safely.  We'll talk about why where you live matters, how to find a reputable provider, and the red flags to watch out for. So if you've been curious about peptides but unsure where to start, this podcast is for you.  Why Peptides? And Why You Need to Be Cautious So first, what are peptides? In short, they're short chains of amino acids—basically, the building blocks of proteins—that signal your body to perform specific actions. Some stimulate growth hormone, others help with weight loss, repair tissue, or improve cognition. Sounds amazing, right? And they can be. But, only when used safely and under the guidance of a qualified provider. Peptides aren't regulated the way pharmaceuticals are, so it's incredibly easy to run into unlicensed sources, impure peptides, or outright scams. Why Where You Live Matters Let's talk geography for a minute. Depending on where you live—whether that's in the U.S., Canada, Mexico, or Europe and other parts of the world—the legal status and availability of peptides vary widely. In the U.S., many peptides are still considered “research chemicals,” meaning they can be sold online but not legally for human use unless prescribed by a licensed provider working with a compounding pharmacy regulated by the FDA. In Canada, peptides are more restricted, and access may require going through clinical trials or specific wellness clinics. Interestingly, in parts of Europe, peptides like BPC-157 have been in clinical use since the 1990s, as it was originally developed and researched in Croatia. So what's the takeaway? The laws in your region affect what's legal, what's safe, and what kind of provider you should be working with. That's why it's important to find someone who not only understands peptide therapy but also works within your country's regulatory framework. How to Find a Reputable Peptide Therapy Provider So now you're wondering: Okay, then who DO I trust? Great question. Let's go over some things you should look for when wanting to start a particular peptide therapy. Credentials Your provider should be a licensed clinician—an MD, DO, PharmD, PA, or NP—with specific training in peptide therapy, functional, or regenerative medicine. Bonus points if they're certified by organizations like SSRP (Seeds Scientific Research & Performance), the A4M (American Academy of Anti-Aging Medicine), or IFM  (Institute for Functional Medicine). Provider Works with Licensed Compounding Pharmacies or Peptide Manufacturers Avoid providers who suggest buying your peptides online or mixing them at home. Thorough Evaluation Process Prior to Treatment The first and most critical step in a full medical workup is gathering a comprehensive medical history. This includes a detailed review of your personal health background—such as any chronic conditions, previous illnesses, surgeries, or hospitalizations—as well as your current medications and supplements. Your provider will also explore your family medical history to identify any contraindications to peptide therapy. Laboratory testing may be obtained if clinically indicated depending on the particular peptide therapy and based on your symptoms, medical history, and treatment goals. Another key component of a full medical workup is the functional assessment, which goes beyond lab numbers to evaluate how your body is actually performing day to day.  This includes an in-depth discussion of your sleep quality, energy levels, cognitive function, mood, libido, and overall sense of well-being. Your provider may also ask about your ability to recover from exercise, your stress resilience, and whether you're experiencing symptoms like brain fog, fatigue, or low motivation. For those seeking peptide therapy for performance or longevity, this assessment helps establish baseline functioning and goals, so treatment can be tailored not just to correct deficiencies, but to optimize quality of life and daily performance. Follow-up Care and Dosing Guidance Peptides aren't one-size-fits-all. You need personalized dosing, cycle recommendations, peptide stacking, and monitoring. If you're not getting that, you're not being cared for safely. Red Flags  “For research only” Let's get real and talk about some red flags you may come across when doing your research. The internet is full of what I like to call “peptide pirates.” These are websites that sell cheap peptides labeled “for research only.” They might even look legit, but here's the thing, there's no regulation, no guarantee of purity or potency, and no support during your peptide therapy journey. Low cost and hidden fees Keep in mind that peptides are often expensive due to several factors. They require complex, specialized manufacturing processes, which include synthesis and purification to ensure quality and purity. Additionally, high-quality peptides are typically produced in small batches by licensed compounding pharmacies or peptide manufacturers, which increases costs. The research and development and regulatory compliance required to ensure their safety and efficacy also contribute to the higher price point.  If the prices from online peptide providers/clinics seem unusually low or too good to be true, there's a high likelihood that the products are either compromised, unregulated, or not what they claim to be. And while we're on the topic of cost, I shouldn't forget to mention hidden fees. You know, the sneaky little charges that pop up after you've been lured in by the words “free consultation.” When you book that initial appointment thinking, “Okay, great. I'll get expert advice, ask a few questions, and figure out if peptide therapy is right for me.” But then what happens? What if you've got more questions after the appointment—maybe you're dealing with side effects, started a new medication and want to be sure there aren't any interactions, or your symptoms have shifted and you're thinking about adjusting your dosage. And just like that, your “free” consultation suddenly comes with a consult price tag. I've personally seen clinics charge $50 just to email a follow-up question or do a “dosage review”. And don't get me started on the “lab interpretation fees.” You either pay for your bloodwork or labs are included, but then they charge you again just to tell you what your results mean.  Cold-chain And lastly, let's not forget that peptides are delicate compounds that require specific storage conditions. Certain peptide providers may not store or ship peptides correctly, affecting their potency and stability. As a general rule, for long-term storage, peptides should be kept frozen in their lyophilized (powder) form to preserve stability. Once reconstituted, most peptides should be stored in the refrigerator and used within the recommended timeframe, typically 2–8 weeks depending on the peptide and diluents used. It's important to avoid repeatedly freezing and thawing, as this can degrade the peptide structure and reduce its effectiveness.  Recap Do your homework. Research providers in your area. Look for peptide clinics or functional or integrative clinics with peptide experience. Ask smart questions. Where do they source peptides? Are the peptides made in a cGMP, FDA-registered facility? What's their follow-up protocol? How do they store and ship their peptides? Trust your gut—and the science. If something feels off, it probably is. Safe peptide therapy is always grounded in evidence and ethical practice. Your health isn't something to gamble with. Peptides can be powerful tools—but only from a trusted source and with guidance. Thank you for listening to The Peptide Podcast. If you enjoyed the show and want to support what we do, head over to our Partners Page. You'll find some amazing brands we trust—and by checking them out, you're helping us keep the podcast going.  Have a happy, healthy week!

In this episode, Dr. Shawn Tassone discusses the complexities and controversies surrounding functional medicine and its distinction from integrative medicine. He critiques the rise of functional medicine practitioners, highlighting issues of credibility, ethical practices, and the commercialization of health services. Dr. Tassone emphasizes the importance of informed consumer choices in navigating the healthcare landscape, particularly in the context of hormone health and wellness. Episode Highlights: Why prevention should be emphasized as a key aspect of healthcare How functional medicine has become as corrupt as traditional medicine The truth about many self-proclaimed functional medicine practitioners who lack proper medical credentials How Integrative Medicine focuses on a team approach to patient care Functional medicine's origins are rooted in addressing chronic diseases Why the criticism of functional medicine includes its reliance on unnecessary testing Reasons consumers should be wary of health scams and marketing tactics How informed consumerism is crucial in the healthcare industry Episode Resources: Dr. Shawn Tassone's Practice | https://www.drshawntassone.com Dr. Shawn Tassone's Book | The Hormone Balance Bible Dr. Shawn Tassone's Integrative Hormonal Mapping System | Hormone Archetype Quiz Thank you to our sponsor, Purality Health! The question isn't which supplements to take—it's whether your body can absorb them. Most traditional supplements fall victim to stomach acid before delivering benefits. Purality Health's micelle liposomal technology creates a double-layer protective system that shields nutrients from stomach acid destruction while facilitating direct bloodstream absorption—making supplements up to 800% more effective. For perimenopausal and menopausal patients, I recommend their Vitamin D3 with K2 for bone density and mood regulation, and their exceptional magnesium formula for sleep and muscle tension. As a physician, I value their commitment to quality: cGMP-compliant facilities, purity testing, and organic, non-GMO ingredients without unnecessary fillers. Visit puralityhealth.com/drshawn and use code DRSHAWN for exclusive savings. Thank you to our sponsor, Endurance Products Company! After over 25 years of practicing medicine, I'll be the first to tell you that not all supplements are created equal. But when I discovered Dihydroberberine SR, by Endurance Products Company, I was genuinely impressed.  It's highly bioavailable and outperforms standard berberine at significantly lower doses. You can explore their offerings at endur.com. Not only is the science solid, but I love that Endurance Products Company is a family-run American company that has cared about doing things right since 1978. I've started recommending Dihydroberberine to my patients who struggle with blood sugar management, and the results speak for themselves. So much so, that I personally take this supplement for helping to support healthy blood sugar levels, heart health, and tap into how my body uses fats for energy As a special offer for my audience, Endurance Products Company is providing a 10% discount on your order! Simply use the code DRT10 at checkout when you visit endur.com. Medical Disclaimer This podcast and website represent the opinions of Dr. Shawn Tassone and his guests. The content here should not be taken as medical advice and is for informational purposes only. Because each person is so unique, please consult your health care professional for any medical questions.

In this episode of The Hormone Genius, we sit down with Haley Yeager to explore a topic every woman deserves to understand—how charting your cycle can be a life-changing tool for health, healing, and wholeness. Contrary to popular belief, menstrual cycle charting isn't just for family planning. It's one of the most powerful insights a woman can have into her overall health. A well-charted cycle acts like a monthly report card, revealing signs of hormonal imbalances, fertility struggles, or conditions like PCOS and endometriosis. It's not just about reproduction—it's about connection with your body. We also discuss the widespread use of hormonal birth control as a catch-all solution for reproductive concerns. While the pill may manage symptoms, it often masks the real issue, delaying diagnosis and treatment. True healing begins with understanding what's actually happening in the body—and that starts with cycle awareness. Haley shares her own powerful journey. At 16, she was prescribed the pill to manage irregular periods but quickly experienced intense side effects. Unsatisfied with masking symptoms, she turned to cycle charting and, through the help of a knowledgeable OBGYN, was diagnosed with PCOS. This shift allowed her to manage her health naturally—and ultimately led to the conception of her three beautiful children.

Chatterheads, for those who have been with us since the Sunday Shenanigan days, stuck around for last season's Midweek Meltdowns... Somehow, WE'VE BEEN RENEWED FOR SEASON 3 here at Tables, Ladders, and Chatter! Tonight we bring our best analysis of the weeks following Wrestlemania 41, discuss theories leading into Backlash... And Tommy Gunns gives his "State of Wrestling" address to continue his reign as TLC Predictions Champion!Thanks To Our Sponsors:Reaper Apparel Co⁠⁠⁠⁠⁠⁠ - Reaper is not only a brand, its a complete life adjustment. A commitment to live your most authentic way every single day! Use discount code: Zero815 for 10% off your order!⁠⁠⁠⁠⁠⁠Psycho Pharma⁠⁠⁠⁠⁠⁠ - Psycho Pharma is a fast-growing company that innovates aggressive formulas to be better than most of the run of the mill products many other brands produce. All Psycho Pharma products are produced in an FDA registered manufacturing facility that follows cGMP standards, with assays on each ingredient and COA's/batch records kept for every run. Use discount code: PONYBOY815 for 20% off your order!

Documentation Hierarchy and Best Practices in Quality Systems with Aaron SnyderIn this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in quality systems, which serves as the backbone of compliance. Key topics include the hierarchy of regulations, document management best practices, the intricacies of quality manuals, and the critical distinctions between SOPs and work instructions. Additionally, they explore the interconnectedness of document control and training, emphasizing the importance of defined roles and responsibilities within organizations. Listeners are provided with insights into establishing and maintaining effective documentation systems while ensuring adherence to regulatory requirements.00:00 Introduction and Guest Introduction00:37 The Importance of Documentation in Quality Systems01:30 Hierarchy and Structure of Documentation02:44 Standard Operating Procedures (SOPs) vs. Work Instructions11:22 Document Control and Change Management15:52 Roles and Responsibilities in Quality Systems18:20 RACI Matrix and Its Importance20:47 Common Issues in Documentation and Training25:25 Conclusion and Where to Find More InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Chatterheads, It's that time of the year once again and we've come full circle... The Big 4 Predictions has been a wild ride and Tommy Gunns still holds the title... But will he remain the champion after this weekend's Wrestlemania 41 in Las Vegas, Nevada... Only time will tell and may Lady Luck be on his side!⁠⁠⁠Reaper Apparel Co⁠⁠⁠⁠⁠ - Reaper is not only a brand, its a complete life adjustment. A commitment to live your most authentic way every single day! Use discount code: Zero815 for 10% off your order!⁠⁠⁠⁠⁠Psycho Pharma⁠⁠⁠⁠⁠ - Psycho Pharma is a fast-growing company that innovates aggressive formulas to be better than most of the run of the mill products many other brands produce. All Psycho Pharma products are produced in an FDA registered manufacturing facility that follows cGMP standards, with assays on each ingredient and COA's/batch records kept for every run. Use discount code: PONYBOY815 for 20% off your order!

What a chaotic week it's, been Chatterheads... And to bring it all into perspective with their own cynical twists are your three faithful hosts, Tommy Gunns, Ponyboy, and Zero! Let's not waste anymore time, it's time for MIDWEEK MELTDOWN!⁠⁠⁠Reaper Apparel Co⁠⁠⁠⁠ - Reaper is not only a brand, its a complete life adjustment. A commitment to live your most authentic way every single day! Use discount code: Zero815 for 10% off your order!⁠⁠⁠⁠Psycho Pharma⁠⁠⁠⁠ - Psycho Pharma is a fast-growing company that innovates aggressive formulas to be better than most of the run of the mill products many other brands produce. All Psycho Pharma products are produced in an FDA registered manufacturing facility that follows cGMP standards, with assays on each ingredient and COA's/batch records kept for every run. Use discount code: PONYBOY815 for 20% off your order!

Chatterheads, Tommy Gunns has taken the night off to spend time with his family, on that note.... Looks like you're stuck with the brothers; Ponyboy and Zero for this next installment of Midweek Meltdown as we enter the final weeks before Wrestlemania 41!⁠⁠⁠Reaper Apparel Co⁠⁠⁠⁠ - Reaper is not only a brand, its a complete life adjustment. A commitment to live your most authentic way every single day! Use discount code: Zero815 for 10% off your order!⁠⁠⁠⁠Psycho Pharma⁠⁠⁠⁠ - Psycho Pharma is a fast-growing company that innovates aggressive formulas to be better than most of the run of the mill products many other brands produce. All Psycho Pharma products are produced in an FDA registered manufacturing facility that follows cGMP standards, with assays on each ingredient and COA's/batch records kept for every run. Use discount code: PONYBOY815 for 20% off your order!

In this latest episode of Proven Health Alternatives, I sit down with Dr. Eric Viegas, a Medical Product Manager, to break down the booming supplement industry and its crucial role in modern health. We discuss why supplements are essential for many people today—helping to fill critical nutrient gaps in our diets. But with that rise in demand comes a major challenge: quality control. Dr. Viegas sheds light on the risks of low-quality supplements, from inconsistent potency to contamination, and shares key strategies for ensuring product credibility—like looking for third-party testing and CGMP certifications. Whether you're a practitioner or a health-conscious consumer, this episode will help you navigate the supplement market with confidence and make informed choices for better health. Key Takeaways: Supplement Quality Indicators: Learn how third-party CGMP certification and brand credibility play critical roles in ensuring safe and effective dietary supplements. Understanding Fillers and Forms: Dr. Viegas explains the importance of bioavailability in nutrient absorption, specifically how certain forms like chelated minerals are superior. Top Supplement Choices: The discussion includes various popular supplements like magnesium, omega-3s, and probiotics, and offers insights into their best applications and benefits. Role of Practitioners: Emphasizing the need for practitioner guidance in supplement selection, the episode discusses how healthcare professionals can integrate quality assessments into patient education. The Danger of Misinformation: Tips on discerning credible supplement information from prevalent misinformation on social media platforms are provided, helping consumers make informed decisions. More About Dr. Eric Viegas: Dr. Eric Viegas is a licensed naturopathic doctor in Ontario, Canada. He is currently serving as the Medical Product Manager and Medical Advisor at Fullscript, where he focuses on whole person care, supplement quality, and practitioner education. With extensive experience in the supplement industry, Dr. Viegas works closely with practitioners to ensure they have access to high-quality, research-backed supplements for their patients. He is passionate about educating both healthcare providers and patients on the importance of proper supplementation and how to navigate the ever-expanding supplement market with confidence.

Officially coming to you live during the official midweek... IT'S MIDWEEK MELTDOWN WITH YOUR WONDERFUL HOSTS TOMMY GUNNS, PONYBOY, and ZERO!!!⁠⁠⁠Reaper Apparel Co⁠⁠⁠ - Reaper is not only a brand, its a complete life adjustment. A commitment to live your most authentic way every single day! Use discount code: Zero815 for 10% off your order!⁠⁠⁠Psycho Pharma⁠⁠⁠ - Psycho Pharma is a fast-growing company that innovates aggressive formulas to be better than most of the run of the mill products many other brands produce. All Psycho Pharma products are produced in an FDA registered manufacturing facility that follows cGMP standards, with assays on each ingredient and COA's/batch records kept for every run. Use discount code: PONYBOY815 for 20% off your order!

I am back!!!!!! And not only am I back BUT this is a VERY SPECIAL release because it is my 50TH episode and it is super appropriate that as I approach my 1 year Anniversary of owning Evergreen Nutrition in Eugene, OR that this episode is shared!   On this episode of Totally Exposed I got to sit down with Allie Hobson from Core Formulas 1/2 of the fabulous duo to the company!  Allie is a FTNP, RWP and she and Emily Morrow saw a huge need for supplements that get back to the basics and foundations.  There is a lot of nasty ingredients used as fillers in supplements and Core Formulas believes in giving the consumer full transparency and clarity on what are Foundational supports.  They are an American made company with no chemical fillers, no artificial anything, tested for purity and CGMP compliant. This episode is for the listener who wants to learn more about what to look for in a supplement and what to stay away from!  So pull up a chair, a cozy blanket and get ready to find all the golden nuggets throughout our talk! 

YAWN!!! Boy it's been a relaxing few weeks away from Midweek Meltdown, and we hope you've all missed us live we've missed you... However, let's not waste any time as we get right back where we left off... Well sorta! ANYWAY, here comes Zero, Ponyboy, and Tommy Gunns... Did ya see what I did there with the title by the way? HA HA HA!... "I'm so lonely..." - Conquest from "Invincible"⁠⁠Reaper Apparel Co⁠⁠ - Reaper is not only a brand, its a complete life adjustment. A commitment to live your most authentic way every single day! Use discount code: Zero815 for 10% off your order!⁠⁠Psycho Pharma⁠⁠ - Psycho Pharma is a fast-growing company that innovates aggressive formulas to be better than most of the run of the mill products many other brands produce. All Psycho Pharma products are produced in an FDA registered manufacturing facility that follows cGMP standards, with assays on each ingredient and COA's/batch records kept for every run. Use discount code: PONYBOY815 for 20% off your order!

Introduction: Guests: Dennis Katz (President) & Michael Macione (VP of Sales & Marketing), founders of Doctor Inspired Formulations Recorded at: ILADS Conference, the largest Lyme disease conference in the world Focus: Providing high-quality, standardized supplements for the Lyme disease community Key Points: Background and Inspiration for Doctor-Inspired Formulations Founded in response to physicians' frustrations over inconsistent supplement quality Initially launched with Mimosa pudica and liposomal artemisinin to ensure proper dosing and purity Challenges in Sourcing and Standardizing Supplements Difficulty in obtaining high-quality, contaminant-free raw materials Rigorous quality control, including certificates of analysis for every batch Expanding Product Line to Meet Lyme Community Needs Grew from 2 to 8 products based on feedback from Lyme-literate doctors and patients Offerings include liposomal curcumin, oregano oil, artemisinin, and Mimosa pudica Enhancing Bioavailability and Reducing Inflammation Use of enteric coating, micronization, and carrier oils to maximize absorption Formulations designed to reduce common side effects Key Products and Their Uses Cinnamon-Clove-Oregano Formula: Supports biofilm disruption and Lyme persisters, included in Dr. Horowitz's protocol Whisbax Topical Spray/Cream: Designed for skin issues like actinomyces and post-tick bite support Commitment to Quality and Customer Service Manufactured in the U.S. in cGMP-certified facilities with stringent testing protocols Small company with a direct line of communication between founders and customers Conclusion: Doctor Inspired Formulations is dedicated to providing standardized, pharmaceutical-grade supplements for the Lyme community Founders emphasize the importance of transparency, quality, and patient-centered innovation Resources & Links:

Dr. Stephanie's Natural Supplements for Health & Wellness - formulated by Dr. Stephanie Redmond, PharmD, CDCES, BC-ADM. The products are crafted to simplify your wellness journey with all-in-one formulas that save you time & money – providing options for weight support, general health, and motherhood. Available for purchase at Amazon, Walmart, CVS, Walgreens, Kroger, and more.  Dr. Stephanie's Natural Supplements for Health & Wellness - formulated by Dr. Stephanie Redmond, PharmD, CDCES, BC-ADM. The products are crafted to simplify your wellness journey with all-in-one formulas that save you time & money – providing options for weight support, general health, and motherhood. Available for purchase at Amazon, Walmart, CVS, Walgreens, Kroger, and more.  https://byebyeweekend.com Key Information: Your Health, Simplified: Taking control of your health with natural solutions shouldn't be overwhelming. Dr. Stephanie's products are crafted to simplify your wellness journey with all-in-one formulas that save you time and money. We've done the research and combined the right ingredients in clinically effective doses to address your specific health needs. Clinically-Backed Doses: Our mission is to create supplements that prioritize efficacy over marketing gimmicks and proprietary doses. Every ingredient and dosage in Dr. Stephanie's products is supported by clinical studies, ensuring that each formula contains enough of the right ingredients to truly make a difference. Clean & High-Quality Ingredients: Your safety is our top priority. Dr. Stephanie's supplements are made in the USA in a cGMP facility and undergo third-party testing to guarantee accuracy, safety, and purity. We source only the highest-quality ingredients, so you can trust what's in every bottle. Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action). They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems. The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries.00:00 Introduction and Guest Introduction00:33 Understanding CAPA in Pharma and MedTech01:08 Regulatory Differences and Their Implications03:12 Event Handling and Investigation Processes08:13 CAPA System Effectiveness13:57 Quality System Approaches in Pharma and MedTech26:22 Root Cause Analysis and Continuous Improvement30:43 Conclusion and Contact InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Chatterheads, we are back for another episode of Midweek Meltdown... What can we say? It's Wrestlemania season, but before we get there we have one stop going through Toronto... The Elimination Chamber is less than two week away and what can we say? It's loaded!A special thank you to our sponsors:⁠Reaper Apparel Co⁠ - Reaper is not only a brand, its a complete life adjustment. A commitment to live your most authentic way every single day! Use discount code: Zero815 for 10% off your order!⁠Psycho Pharma⁠ - Psycho Pharma is a fast-growing company that innovates aggressive formulas to be better than most of the run of the mill products many other brands produce. All Psycho Pharma products are produced in an FDA registered manufacturing facility that follows cGMP standards, with assays on each ingredient and COA's/batch records kept for every run. Use discount code: PONYBOY815 for 20% off your order!

In this episode of the Life Science Success Podcast, my guest is Forrest Brown, President of Germfree, a pioneering company in mobile laboratory and biocontainment solutions. With a Summa Cum Laude degree in Biomedical Engineering and an impressive career transforming CGMP facilities, Forrest brings a wealth of strategic leadership and technical expertise to our conversation today. 00:00 Introduction to Life Science Success Podcast 00:42 Sponsor Message: Bio on the Bayou 2025 02:16 Guest Introduction: Forrest Brown of Germfree 02:51 Forrest Brown's Career Journey 06:19 Germfree's Global Reach and Client Engagement 11:01 Challenges and Innovations in Pharmaceutical Solutions 20:48 Leadership and Industry Insights 35:30 Concluding Thoughts and Farewell

Chatterheads, let's cut to the chase... The Royal Rumble has come and gone and while there were some surprise returns... It seemed to be lacking... What do your TLC Boys have to say about it? Tune in and find out NOW on MIDWEEK MELTDOWN! A special thank you to our sponsors: ⁠Reaper Apparel Co⁠ - Reaper is not only a brand, its a complete life adjustment. A commitment to live your most authentic way every single day! Use discount code: Zero815 for 10% off your order! ⁠Psycho Pharma⁠ - Psycho Pharma is a fast-growing company that innovates aggressive formulas to be better than most of the run of the mill products many other brands produce. All Psycho Pharma products are produced in an FDA registered manufacturing facility that follows cGMP standards, with assays on each ingredient and COA's/batch records kept for every run. Use discount code: PONYBOY815 for 20% off your order!

Rounding out the year Chatterheads we have hit the Royal Rumble Prediction SHOW!!! Tonight is a special episode as we give our thoughts and insight as well as lay it all on the line to make our predictions heading into Wrestlemania Season... The Road begins this Saturday!!! A special thank you to our sponsors: ⁠Reaper Apparel Co⁠ - Reaper is not only a brand, its a complete life adjustment. A commitment to live your most authentic way every single day! Use discount code: Zero815 for 10% off your order!⁠ Psycho Pharma⁠ - Psycho Pharma is a fast-growing company that innovates aggressive formulas to be better than most of the run of the mill products many other brands produce. All Psycho Pharma products are produced in an FDA registered manufacturing facility that follows cGMP standards, with assays on each ingredient and COA's/batch records kept for every run. Use discount code: PONYBOY815 for 20% off your order!

Chatterheads, welcome back to Midweek Meltdown with your hosts, Tommy Gunns, Ponyboy, and returning from recovery and vacation, Zero!!! Tonight the stakes are high... as we are just one week out from our Royal Rumble Predictions showcase! A special thank you to our sponsors: Reaper Apparel Co - Reaper is not only a brand, its a complete life adjustment. A commitment to live your most authentic way every single day! Use discount code: Zero815 for 10% off your order! Psycho Pharma - Psycho Pharma is a fast-growing company that innovates aggressive formulas to be better than most of the run of the mill products many other brands produce. All Psycho Pharma products are produced in an FDA registered manufacturing facility that follows cGMP standards, with assays on each ingredient and COA's/batch records kept for every run. Use discount code: PONYBOY815 for 20% off your order!

In this episode of the RWS Clinician's Corner, Margaret Floyd Barry meets with one of the world's top supplement formulators, Shawn Wells. Not only does Shawn give us the inside scoop on some really powerful new supplement ingredients and formulations, but he delves into the complex process of creating supplements, improving their bioavailability, and the science behind new, innovative ingredients on the market. We also explore the exciting world of exercise mimetics and their potential health benefits, especially for those unable to train due to severe health conditions. Plus, you'll hear about the exciting new ingredient, paraxanthine, and how it might soon revolutionize the market.  We discuss:   The supplement formulation process, with an emphasis on quality control and compliance How Shawn thinks about developing novel ingredients  Dihydroberine, L-ergothioneine & Spermidine: what they do and why they're important NAD and aging Benefits of Paraxanthine and Dileucine  Using Creatine for health (not just building muscle) - one of Shawn's top recommendations Blood sugar management with ​​Dihydroberine (vs. Metformin) Supplement integrity: key things to watch out for when researching a new product or line The Clinician's Corner is brought to you by Restorative Wellness Solutions.  Follow us: https://www.instagram.com/restorativewellnesssolutions/ Timestamps:  00:00 Mother sold Shackley vitamins; early supplement industry. 06:21 Vitamin C research explores higher doses, benefits. 15:57 Paraxanthine benefits without caffeine's side effects. 20:23 Attention to detail signifies brand quality control. 27:31 Supplements: Can't claim cures, only support wellness. 29:04 High-earning products must be tailored to individuals. 35:04 Restorative Wellness Solutions: Transformative health practitioner training. 43:44 Mitochondrial health is crucial for combating aging. 48:07 NAD declines with age; polyphenols inhibit breakdown. 51:39 No caffeine side effects; boosts nitric oxide, dopamine. 59:44 Optimize leucine spikes for protein synthesis effectiveness. 01:01:53 Mitochondria abundance supports high energy cells. 01:06:51 Join, follow, share, suggest topics, change health. Speaker bio:  Shawn Wells MPH, LDN, RD, CISSN, FISSN is the world's leading nutritional biochemist and expert on health optimization. He has formulated over 700 supplements, food, beverages, and cosmeceuticals and patented 20 novel ingredients including Teacrine, Dynamine and Dihydroberberine and is now known as the “ingredientologist” - the scientist of ingredients.  Formerly a Chief Clinical Dietitian with over a decade of clinical experience, he has counseled thousands of people on innovative health solutions such as keto, paleo, fasting, and supplements. He has also personally overcome various health issues including Epstein-Barr Virus, Chronic Fatigue Syndrome, Fibromyalgia, depression, insomnia, obesity, and a pituitary tumor. As a world-renowned thought-leader on mitochondrial health, he has been paid to speak on five different continents. His insights have been prominently featured in documentaries and podcasts like Ben Greenfield and regularly on morning television. His expertise can help any health-conscious individual to better manage stress and experience greater resilience and more energy through utilizing his practical research-backed solutions. His book, The Energy Formula, has been recognized by both USA Today and Forbes as well as an Amazon best-seller in multiple categories.   Connect with Shawn Wells: Website: https://shawnwells.com/ Instagram: https://www.instagram.com/shawnwells/   And find his book, The Energy Formula, here. Keywords:  supplement formulation, Shawn Wells, dihydroberine, paraxanthine, bioavailability, pharmacokinetics, cognitive function, physiological benefits, metformin alternatives, CGMP certification, exercise mimetics, L-valine, Albeba, insulin sensitivity, mitochondrial health, longevity vitamins, L-ergothioneine, spermidine, anti-aging supplements, NAD levels, NMN vs NR, apigenin, fisetin, autoimmune diseases, gluten sensitivities, paresthesis, caffeine metabolites, dileucine, continuous glucose monitor, acetyl-L-carnitine, creatine Disclaimer: The views expressed in the RWS Clinician's Corner series are those of the individual speakers and interviewees, and do not necessarily reflect the views of Restorative Wellness Solutions, LLC. Restorative Wellness Solutions, LLC does not specifically endorse or approve of any of the information or opinions expressed in the RWS Clinician's Corner series. The information and opinions expressed in the RWS Clinician's Corner series are for educational purposes only and should not be construed as medical advice. If you have any medical concerns, please consult with a qualified healthcare professional. Restorative Wellness Solutions, LLC is not liable for any damages or injuries that may result from the use of the information or opinions expressed in the RWS Clinician's Corner series. By viewing or listening to this information, you agree to hold Restorative Wellness Solutions, LLC harmless from any and all claims, demands, and causes of action arising out of or in connection with your participation. Thank you for your understanding.  

Host Emily Walsh Martin, PhD, is joined by Chris Choi, PhD, Roswell Park Comprehensive Cancer Center's Senior Vice President of Industry Partnerships and Technical Director of the center's new Good Manufacturing Practice (cGMP) Facility. Dr. Choi is also an associate professor of oncology. This wide-ranging conversation covers cell therapy development and manufacturing and how the growing Roswell Park Center is aiming to support sponsors in the CAR T and cell therapy space. Emily and Chris also discuss their experiences on cross-functional teams and how a program's research, manufacturing, and clinical elements must be knit together for success. Music by: https://www.steven-obrien.net/--------------------------Bright New Morning - Steven O'Brien (Used for free under a Creative Commons Attribution 4.0 License: https://creativecommons.org/licenses/by/4.0/)Show your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.

Send us a textYo, yo, yo, yo...how are all you Vipers doin? Mr and Mrs Weedman are getting normal with a sesh of Sub Zero from their friends @MidwestTerps.  They share their latest adventures from the Chicagoland cannabis scene and then get right into delivering some big cannabis articles, reports, political news, and stories from all around this big beautiful world.  Mr Weedman shares a study from the National Cancer Institute where researchers tracked cannabis use data from cancer and pain therapy patients, another report talking about the potential for cannabis use to build confidence, and a story on the need for policy change to support out-of-pocket costs for medical cannabis patients.  Mrs. Weedman shares a perspective on cannabis use during pregnancy, the unknown risks of using cannabis while taking Ozempic, and an in-depth report on the benefits of cGMP compliance being initiated in cannabis production facilities prior to being required, and much more. Thanks for listening and as always, hit us up!TWITTER: @weedman420podIG: @weedman420chronicles2.0YouTube: Weedman420 ChroniclesEMAIL:  weedman420chronicles@gmail.comSHOP: www.eightdecades.comIG: @eightdecadesEMAIL: eightdecadesinfo@gmail.com#ImHigh #Cannabis #StomptheStigma #HomeGrow #FreethePlant #Stoners #Burners #rosin #liverosin #Potheads #Vipers #CannabisEducation #CannabisResearch #Weed #Marijuana #LegalizeIt #CannabisNews #CBD #Terpenes  #Podcast #CannabisPodcast #eightdecades #LPP #Lifestyle #HealthyLifestyle #NaturalMedicine #PlantMedicine #News #Research #MedicalMarijuana #Infused #420 #Education #Health #Wellness #WorldNews #Gardening #budtender #kief #hemp #dabs #hash #joints #edibles #gummies #tincture #vapes #esters #pauliesayssmokesmartArticle Links:* https://www.marijuanamoment.net/federal-agency-examines-core-questions-about-medical-marijuana-for-cancer-including-as-an-opioid-alternative-to-treat-pain/* https://www.mercurynews.com/2024/09/25/can-marijuana-help-you-build-confidence/* https://thefreshtoast.com/culture/can-you-consume-marijuana-on-ozempic/* https://www.marijuanamoment.net/most-pain-patients-and-doctors-support-legalizing-medical-marijuana-and-having-insurance-companies-cover-the-cost-ama-study-shows/* https://www.cannabissciencetech.com/view/how-regulation-and-quality-assurance-can-ease-fears-about-cannabis-legalization-ahead-of-a-critical-electionCOPYRIGHT 2021 WeedMan420Chronicles©

Part 4 of 4. My guest for this week's episode is Derek Hennecke, a veteran biotech entrepreneur and board member with over 30 years of experience in the CDMO industry, whose mission is to support the biotech revolution and create value for patients, customers, and investors. In addition to his Board work, Derek previously held leadership positions at DSM and was the Founder and CEO of Xcelience, a Florida-based CDMO specializing in preformulation, micronization, analytical services, formulation development, cGMP manufacturing, and more. Derek eventually sold Xcelience to Capsugel (now Lonza) in 2016. His extensive pharma and cell therapy expertise makes for an insightful conversation that founders can learn from.

Part 3 of 4. My guest for this week's episode is Derek Hennecke, a veteran biotech entrepreneur and board member with over 30 years of experience in the CDMO industry, whose mission is to support the biotech revolution and create value for patients, customers, and investors. In addition to his Board work, Derek previously held leadership positions at DSM and was the Founder and CEO of Xcelience, which he eventually sold to Capsugel Lonza in 2016. Xcelience was a Florida-based CDMO specializing in preformulation, micronization, analytical services, formulation development, cGMP manufacturing, and more. His extensive pharma and cell therapy expertise makes for an insightful conversation that founders can learn from.

While some of us knew a good bit about mRNA prior to 2020, we all got a crash course on mRNA technology and its prophylactic and therapeutic potential as a result of the COVID pandemic and subsequent SARS CoV-2 vaccine development. In fact, most of us have now received at least one mRNA vaccine at this point. Our guest for this episode, Dr. Christian Cobaugh, Co-founder and CEO of Vernal Biosciences, was a passionate believer in mRNA medicines well before the pandemic. Join us to hear his story and his passion for this technology. He walks us through the molecular methods by which high-purity mRNAs are now made and purified, as well as going into the lipid nanoparticle technology by which they're commonly delivered. As a contract development and manufacturing provider, we get to learn about the state of the market and what clients of their care about today. As a seasoned expert in this space, Christian talks about the future potential of mRNA technology for applications such as personalized cancer vaccines. If you enjoy hearing smart people talk about interesting topics with a passion, you won't want to miss this episode! Subscribe to get future episodes as they drop and if you like what you're hearing we hope you'll share a review or recommend the series to a colleague.  Download Transcripts: Speaking of Mol Bio Podcast | Thermo Fisher Scientific - US Visit the Invitrogen School of Molecular Biology to access helpful molecular biology resources and educational content, and please share this resource with anyone you know working in molecular biology.

Part 2 of 4. My guest for this week's episode is Derek Hennecke, a veteran biotech entrepreneur and board member with over 30 years of experience in the CDMO industry, whose mission is to support the biotech revolution and create value for patients, customers, and investors. In addition to his Board work, Derek previously held leadership positions at DSM and was the Founder and CEO of Xcelience, which he eventually sold to Capsugel Lonza in 2016. Xcelience was a Florida-based CDMO that specialized in preformulation, micronization, analytical services, formulation development, cGMP manufacturing, and more. His extensive expertise in pharma and cell therapy makes for an insightful conversation that founders can learn from.

Part 1 of 4. My guest for this week's episode is Derek Hennecke, a veteran biotech entrepreneur and board member with over 30 years of experience in the CDMO industry, whose mission is to support the biotech revolution and create value for patients, customers, and investors. In addition to his Board work, Derek previously held leadership positions at DSM and was the Founder and CEO of Xcelience, which he eventually sold to Capsugel Lonza in 2016. Xcelience was a Florida-based CDMO that specialized in preformulation, micronization, analytical services, formulation development, cGMP manufacturing, and more. His extensive expertise in pharma and cell therapy makes for an insightful conversation that founders can learn from.

In this episode of our “Automation Chat” podcast from The Journal From Rockwell Automation and Our PartnerNetwork magazine, Executive Editor Theresa Houck chats with Ashley David, Product Marketing Manager for Level and Pressure Equipment at Endress+Hauser USA. They discuss: What exactly “smart instrumentation” is in process automation. Where the industry is headed with smart instrumentation and why. Why diagnostics, verification and monitoring functions are vital. How data collected from smart devices is used to improve productivity, cut maintenance costs, reduce paperwork, comply with legal requirements, help ensure safety and more. Smart instrumentation's role in optimizing calibration and cGMP compliance in the life sciences industry. What to know if you're not sure smart devices in process instrumentation are right for you. And as always, get your family-friendly, silly Joke of the Day. Resources from this episode: Learn about Heartbeat Technology on Proline Promag electromagnetic flowmeters from Endress+Hauser. Learn about benefits of Heartbeat Technology in smart instrumentation. Case Study: New Belgium Brewing refines calibration process. Endress+Hauser website. Subscribe to The Journal's 4 print magazines (Feb., May, July and Oct.) by e-mailing Anna Hicks at ahicks@endeavorbusinessmedia.com. Subscribe to our 4 digital magazines at http://rok.auto/thejournal-subscribe.   You can also watch their discussion on YouTube at https://youtu.be/3TlUFOKrkJ4. Automation Chat is brought to you by The Journal From Rockwell Automation and Our PartnerNetwork magazine. Find us on LinkedIn. Find us on Facebook. Find us on X (Twitter). Please subscribe to “Automation Chat" and give us a 5-star rating and a review. ** Named “Best Podcast” 3 Consecutive Years! 2022-2024 Apex Award of Publication Excellence.

From simple biomarker tests to cutting-edge precision medicine, the diagnostics industry is navigating a complex landscape of regulatory changes and technological advancements. In this episode, Andrew L'Huillier, a leader in the diagnostics industry and Director of Regulatory Affairs Liaison - Diagnostics at Merck, discusses his work on FlowScript and other groundbreaking diagnostic products. Learn about the challenges and opportunities in regulatory compliance, drug discovery, and the implementation of cGMP guidelines. Tune in and discover how precision medicine is revolutionizing healthcare and improving patient care! Resources: Connect with and follow Andrew L'Huillier on LinkedIn. Follow Merck on LinkedIn. Explore the Merck Website! Subscribe to the CDER, CBER, and CDRH newsletters! Discover AgencyIQ and 360Dx!

In this episode of The Top Line, sponsored by the Parenteral Drug Association (PDA), we explore the upcoming PDA/FDA Joint Regulatory Conference, happening September 9-11 in Washington, D.C. Our guest, Janeen Skutnik-Wilkinson, Director of Global Quality Regulatory Surveillance and External Engagement for Moderna and Co-Chair of the 33rd annual event, shares why this conference is the essential annual CGMP event to attend. Janeen notes the direct access to federal regulators and the unique insights from FDA colleagues as standout features. The FDA co-sponsored conference is known for fostering collaboration among scientific minds to create practical solutions and best practices, with this year's focus on improving quality culture, shifting to proactive approaches, and evolving quality maturity. Key sessions will cover de-risking quality control environments by utilizing case studies on OOS and OOT results, and enhancing lab systems with QRM. The conference's focus on Current Good Manufacturing Practices (CGMP) makes it a must attend for quality assurance and operations professionals. Additionally, discussions will delve into the role of AI in manufacturing and data integrity. For a comprehensive look at this year's PDA/FDA Joint Regulatory Conference, listen to the full episode and register at pda.org/PDAFDA2024.See omnystudio.com/listener for privacy information.

In this week's episode Karen is joined by Jaclyn Bellomo, a cosmetic industry professional with over a decade of experience in regulatory compliance. In the USA, up until now, the FDA has managed and maintained all fragrance industry regulations. However, the biggest overhaul in these regulations is about to occur with the introduction of  MOCRA. But these new regulations don't just impact companies selling from the USA, but also companies selling into the USA. So, what is MOCRA, why is it being implemented and what does it mean to you? Find out on this week's show KEY TAKEAWAYS An overhaul like this does not happen without a great need for it. Jaclyn breaks down where the gaps are in the current FDA regulations and how MOCRA will fill these in.  One of the major changes that will come with MOCRA is how the ‘responsible person' protocol works. Jaclyn explains the new system and how it will apply to companies based both in and out of the US. Jaclyn addresses the most significant changes to the new MOCRA system, adverse events. With examples, she breaks down what adverse events are and how these changes will affect you.  Safety substantiation is another aspect that will be given a complete overall with MOCRA, Jaclyn provides an in-depth overview of what the new system will look like. BEST MOMENTS  “It's always a good idea to get feedback from your customers, but even more so now as you can use this feedback for evidence.” “If you don't comply with MOCRA, there are real world consequences.” “If you have a small artisan brand, working from home, one of the new requirements is that you have a learning period.”   EPISODE LINKS www.registrarcorp.com  KarenGilbert15 – code for your listeners to use to get 15% off our services Jaclyns E-mail  VALUABLE RESOURCES Getting Started Guide Artisan Perfumery Mastermind   ABOUT THE GUEST Jaclyn Bellomo is a cosmetic industry professional with over a decade of experience in technical formulation, regulatory compliance, product development, and brand management. Jaclyn has spent the majority of her career in the private sector working with multinational brands, specializing in formulations for the beauty and personal care industry from concept to counter. Jaclyn is active on several committees across the industry that focus on education and compliance to ensure there is continued support for the cosmetic  industry.  In addition, Jaclyn works closely with our Cosmetri Product Manager and cGMP software to help streamline R&D processes, update compliance, and support customers in improving their current working operations. ABOUT THE HOST Fragrance expert, author, teacher and speaker; Karen Gilbert runs courses in the UK and online which demystify the secretive world of perfumery in a fun and interactive way.  Karen has inspired thousands of students to explore their olfactory sense and create their own personalised fragrances. With extensive product development experience in both the commercial perfumery and the organic skincare industry, Karen is able to offer a unique insight into creating natural and mixed media fragrances for fine fragrance, room scents and skincare/bodycare products using commercial perfumery techniques. Karen is also a certified meditation teacher and has a passion for helping people to create daily rituals that integrate scent with other modalities to shift state and increase your sense of wellbeing. CONTACT DETAILS Website Instagram Facebook YouTube Email

Guang Qu, Co-Founder of NGGT Corporation is focused on developing gene therapy products using dual functional vector strategies. Guang highlights the importance of distinguishing between recessive and dominant mutations in rare diseases and explains how their approach differs from other gene therapy approaches. The two leading indications caused by a gene mutation that NGGT is working on are Bietti's Crystalline Dystrophy (BCD), a rare ocular disease, and phenylketonuria (PKU), a metabolic disease.   Guang explains, "For our strategies and our product development strategies, I think we are leveraging our experience in the gene therapy field. Later, I will talk more about myself, Dr. Lixin Jiang, and our team. The other thing we are leveraging is our fully integrated team in gene therapy product development, which involves R&D, research and development, CGMP manufacturers, from tox development and clinical regulatory functions and the medical teams. So with all of the teams we built up in the last couple of years, we're in very good positions in developing our gene therapy products." "So, of the two currently leading indications, one is involved in ocular disease, what we call the BCD, Bietti's Crystalline Dystrophy. This disease is caused by a gene mutation. The gene mutation causes lipid metabolic problems. The particular gene is called the CYP4V2 gene. The mutation directly leads to the lipid metabolic process being interrupted. Therefore, lipids are precipitated in the different ocular cells, such as the cornea and the retina. That's most of the disease cell layers affected."  #AAV #GeneEditing #GeneTherapy #PKU #BCD Listen to the podcast here

Guang Qu, Co-Founder of NGGT Corporation is focused on developing gene therapy products using dual functional vector strategies. Guang highlights the importance of distinguishing between recessive and dominant mutations in rare diseases and explains how their approach differs from other gene therapy approaches. The two leading indications caused by a gene mutation that NGGT is working on are Bietti's Crystalline Dystrophy (BCD), a rare ocular disease, and phenylketonuria (PKU), a metabolic disease.   Guang explains, "For our strategies and our product development strategies, I think we are leveraging our experience in the gene therapy field. Later, I will talk more about myself, Dr. Lixin Jiang, and our team. The other thing we are leveraging is our fully integrated team in gene therapy product development, which involves R&D, research and development, CGMP manufacturers, from tox development and clinical regulatory functions and the medical teams. So with all of the teams we built up in the last couple of years, we're in very good positions in developing our gene therapy products." "So, of the two currently leading indications, one is involved in ocular disease, what we call the BCD, Bietti's Crystalline Dystrophy. This disease is caused by a gene mutation. The gene mutation causes lipid metabolic problems. The particular gene is called the CYP4V2 gene. The mutation directly leads to the lipid metabolic process being interrupted. Therefore, lipids are precipitated in the different ocular cells, such as the cornea and the retina. That's most of the disease cell layers affected."  #AAV #GeneEditing #GeneTherapy #PKU #BCD Download the transcript here

In today's episode, our guest is Vivek Gera, the CEO of Leucine and a seasoned process engineer. Vivek has a wealth of experience leveraging cutting-edge technologies to enhance compliance and operational efficiency within pharmaceutical manufacturing. Throughout this episode, we will delve into the transformative impact of AI on manufacturing, QA, and QC processes, shedding light on how these advancements are revolutionizing productivity and adherence to CGMP guidelines.

This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠reach out to RQM+⁠ if you need support with clinical trials. ❓ What are the CGMP principles and traceability requirements for

"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.

Understanding how to level up in your career can be confusing. Especially when there are so many certifications within the event industry to choose from. This episode will unpack some of the main robust event planning certifications out there to help you make the best choice for your career path.After listening to this episode, you'll be able to understand which direction you want to go in getting certified, or perhaps realize that you are good right where you are. Whatever the case, let's make your decision process easier. Links and ResourcesCMP Study Group - Planners on PurposeCertified Meeting Professional (CMP)Certified Government Meeting Professional (CGMP)Certified Special Events Professional (CSEP)Certified in Exhibition Management (CEM)Certified Destination Management Executive (CDME)Certified Professional in Catering and Events (CPCE)Certification in Meetings Management (CMM)Certified Association Executive (CAE)Thank you so much and stay on purpose!Support the Show.

The FDA Group's Nick Capman sits down with Adam Foresman, Head of Quality & Regulatory Affairs at VideaHealth, to explore the intersection of AI, machine learning, and diagnostics within the FDA's regulatory environment. Adam brings over 15 years of experience in medical device design, quality management systems, and regulatory affairs, with a recent focus on AI in the dental diagnostic market. Discussion points include: The Regulatory Landscape for AI in Dental Diagnostics: Adam shares his insights on how AI and ML are becoming integral in dental diagnostics, aiding in identifying previously missed detections, enhancing patient education, and streamlining administrative tasks. He highlights that early adopters in healthcare and dental organizations are reporting significant benefits from AI, encouraging broader adoption. FDA Clearance for Pediatric AI Applications: Adam sheds light on VideaHealth's recent 510(k) clearance for a dental AI application for pediatric patients. he offers pointers for successful software as a medical device (SaMD) submissions, emphasizing the importance of Q-submissions, thorough software documentation, and specific considerations for pediatric applications. Predetermined Change Control Plans (PCCPs): Adam explains the concept of PCCPs, allowing manufacturers to include future design changes in pre-market submissions, potentially avoiding re-submissions. While he sees broader applications outside of AI, he notes the challenges AI manufacturers face in predicting future design changes accurately. Comparative Regulatory Approaches — US vs. EU: Adam compares regulatory frameworks between the US and the EU, noting that while both aim to ensure clinical benefits outweigh risks, their methodologies differ. He praises the EU's focus on post-market surveillance and risk management processes, suggesting the FDA could benefit from similar approaches. AI Transparency and Bias Considerations: With growing concerns about AI transparency and bias, Adman discusses the FDA's recent emphasis on these issues. He advocates for clear communication of AI test results by subgroups and suggests that the FDA might develop more detailed transparency guidelines in the future. Role of Regulatory Affairs Professionals: Adam encourages regulatory professionals to promote AI understandability and transparency within design teams, ensuring that patient and clinician perspectives are considered in AI development. Future Trends and Recommendations: Adam predicts an increase in AI submissions that bundle multiple models, urging adherence to FDA guidelines for such complex submissions. He also emphasizes the importance of engaging with regulatory bodies early in the design process and maintaining robust QMS processes. Adam Foresman is the Head of Quality & Regulatory Affairs at VideaHealth. with over 15 years of experience in the medical device industry, Adam excels in product quality, quality systems, and regulatory compliance. His expertise encompasses design controls, statistical analysis, internal and external auditing, CAPA management, product performance, metrology program management, cGMP practices, and ISO 13485 & 21 CFR 820 quality management activities. At VideaHealth, Adam has co-developed and executed business strategies, globalization, and the clinical roadmap. He leads efforts in product quality, quality systems, pre-market approvals, and regulatory compliance for cutting-edge artificial intelligence and machine learning diagnostics. Adam is also a champion of cybersecurity and HIPAA activities, ensuring robust protection and privacy for sensitive health data.

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

On this episode I was joined by Aaron Snyder, VP of Quality Assurance at Allotex. Aaron discusses: 00:58 Exploring the Impact of QMSR on Medical Device Companies 02:19 UDI Regulations 05:18 Understanding the FDA's Approach to QMSR and Compliance 18:02 The FDA's Inspection Techniques and the Future of QMSR 31:55 Where to Find Aaron and Closing Thoughts Aaron Snyder is a quality management systems expert and is the VP of QA at Allotex. Prior to joining Allotex, Aaron served in roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. He has worked with a wide range of pharmaceuticals, medical devices and combination products. Aaron is a member of the AAMI Faculty and teaches several courses focused on various QMS topics. Aaron is also and avid content creator and dissects, presents and teaches on QMS and cGMP's topics on his YouTube channel: Quality Systems Explained.

The Gainful Employment rules that were released in October of 2023 will likely impact clock-hour programs in states with minimum clock-hour requirements for licensure or certification, including massage therapy. Les Sweeney, president and CEO of ABMP is joined by Lance Hostetter, Director of Government Relations, to explain the 100% rule, the flaws within the rule itself, and potential advocacy steps schools may wish to pursue. They also speak briefly about the Interstate Massage Compact and how it improves portability and the profession as a whole. Lance Hostetter is the ABMP director of government relations. To contact our ABMP government relations team, email gr@abmp.com Read Lance's recent article in Massage & Bodywork magazine, Why Quality Education Matters, in the March/April addition here   Resources:   https://www.abmp.com/updates/legislative-updates/massage-school-programs-risk-across-country   https://www.abmp.com/updates/legislative-updates/interstate-massage-compact-improves-portability-and-profession     Host:   Les Sweeney is the President and CEO of ABMP. For questions about this episode reach out by emailing expectmore@abmp.com     Sponsors:   Anatomy Trains: www.anatomytrains.com    MYCO CLINIC: www.myco-clinic.com   Elements Massage: www.elementsmassage.com/abmp   Anatomy Trains is a global leader in online anatomy education and also provides in-classroom certification programs for structural integration in the US, Canada, Australia, Europe, Japan, and China, as well as fresh-tissue cadaver dissection labs and weekend courses. The work of Anatomy Trains originated with founder Tom Myers, who mapped the human body into 13 myofascial meridians in his original book, currently in its fourth edition and translated into 12 languages. The principles of Anatomy Trains are used by osteopaths, physical therapists, bodyworkers, massage therapists, personal trainers, yoga, Pilates, Gyrotonics, and other body-minded manual therapists and movement professionals. Anatomy Trains inspires these practitioners to work with holistic anatomy in treating system-wide patterns to provide improved client outcomes in terms of structure and function.                      Website: anatomytrains.com                        Email: info@anatomytrains.com             Facebook: facebook.com/AnatomyTrains                       Instagram: www.instagram.com/anatomytrainsofficial   YouTube: https://www.youtube.com/channel/UC2g6TOEFrX4b-CigknssKHA     Founded by a massage therapist for massage therapists, the Elements Massage brand is a network of independently-owned and operated studios dedicated to changing lives--including yours!  The Elements Massage brand believes massage therapists deserve a supportive team, business and marketing resources, and the chance to learn as much as they want, so many Elements Massage studios offer and reimburse continuing education on an ongoing basis. It's no surprise Elements Massage therapist and client satisfaction leads the industry. That's because from day one, the brand has kept an unmatched commitment to deliver the best therapeutic massage experiences possible for both clients and massage therapists. Elements Massage studios expects the best. So should you. If this sounds like a fit, reach out. Studios are  hiring!    Website: https://elementsmassage.com/ABMP Facebook: https://www.facebook.com/elementsmassage Instagram: https://www.instagram.com/elementsmassage Youtube: https://www.youtube.com/channel/UCXLHkAYMgmA6_MJ8DSEZm-A   Disclaimer: Each Elements Massage® studio is independently owned and operated. Franchise owners (or their designated hiring managers) are solely responsible for all employment and personnel decisions and matters regarding their independently owned and operated studios, including hiring, direction, training, supervision, discipline, discharge, compensation (e.g., wage practices and tax withholding and reporting requirements), and termination of employment. Elements Therapeutic Massage, LLC (ETM) is not involved in, and is not responsible for, employment and personnel matters and decisions made by any franchise owner. All individuals hired by franchise owners' studios are their employees, not those of ETM. Benefits vary by independently owned and operated Elements Massage® studios. Elements Massage® and Elements Massage + design are registered trademarks owned by ETM.   MYCO CLINIC stands at the forefront of natural pain relief and quality patient care.  Backed by 20 years of research and experience developing naturally derived topical products MYCO CLINIC was developed specifically for healthcare professionals and is available in moderate, extra strength and maximum strength formulas in a variety of sizes for in-clinic and home care solutions.   Product benefits include a smooth glide, no greasy residue, no medicinal smell and enhanced natural performance. All ingredients are clean, vegetarian or vegan-friendly, naturally sourced and/or USDA organic extracts. MYCO CLINIC products are manufactured in an FDA registered and cGMP audited facility to ensure the highest quality standards.   Try it today- get your free 10-pack sample of MYCO CLINIC ointment by visiting myco-clinic.com/get-free-samples/   

A young client is comatose after a series of ischemic strokes. They have frequent painful episodes of paroxysmal sympathetic hyperactivity, during which their muscles become spastic and their heart rate and blood pressure rise. Their palliative care team wonders if massage therapy might help the contractures of their limbs, and the massage therapist is willing to try . . . but the results are unexpected.   Resources:   Neurostorming: Causes, Signs, Risks, and Treatment (2022) NewGait. Available at: https://thenewgait.com/blog/neurostorming/ (Accessed: 16 February 2024).   Paroxysmal sympathetic hyperactivity - UpToDate (no date). Available at: https://www.uptodate.com/contents/paroxysmal-sympathetic-hyperactivity (Accessed: 14 February 2024).   Zheng, R.-Z. et al. (2020) ‘Identification and Management of Paroxysmal Sympathetic Hyperactivity After Traumatic Brain Injury', Frontiers in Neurology, 11, p. 81. Available at: https://doi.org/10.3389/fneur.2020.00081.   Verma, R., Giri, P. and Rizvi, I. (2015) ‘Paroxysmal sympathetic hyperactivity in neurological critical care', Indian Journal of Critical Care Medicine : Peer-reviewed, Official Publication of Indian Society of Critical Care Medicine, 19(1), pp. 34–37. Available at: https://doi.org/10.4103/0972-5229.148638.   Xu, S., Zhang, Q. and Li, C. (2023) ‘Paroxysmal Sympathetic Hyperactivity After Acquired Brain Injury: An Integrative Review of Diagnostic and Management Challenges', Neurology and Therapy, 13(1), pp. 11–20. Available at: https://doi.org/10.1007/s40120-023-00561-x.   Host Bio:                    Ruth Werner is a former massage therapist, a writer, and an NCBTMB-approved continuing education provider. She wrote A Massage Therapist's Guide to Pathology, now in its seventh edition, which is used in massage schools worldwide. Werner is also a long-time Massage & Bodywork columnist, most notably of the Pathology Perspectives column. Werner is also ABMP's partner on Pocket Pathology, a web-based app and quick reference program that puts key information for nearly 200 common pathologies at your fingertips. Werner's books are available at www.booksofdiscovery.com. And more information about her is available at www.ruthwerner.com.      Sponsors:     Books of Discovery: www.booksofdiscovery.com   Anatomy Trains: www.anatomytrains.com Elements Massage: www.elementsmassage.com/abmp MYCO CLINIC: www.myco-clinic.com   Anatomy Trains is a global leader in online anatomy education and also provides in-classroom certification programs for structural integration in the US, Canada, Australia, Europe, Japan, and China, as well as fresh-tissue cadaver dissection labs and weekend courses. The work of Anatomy Trains originated with founder Tom Myers, who mapped the human body into 13 myofascial meridians in his original book, currently in its fourth edition and translated into 12 languages. The principles of Anatomy Trains are used by osteopaths, physical therapists, bodyworkers, massage therapists, personal trainers, yoga, Pilates, Gyrotonics, and other body-minded manual therapists and movement professionals. Anatomy Trains inspires these practitioners to work with holistic anatomy in treating system-wide patterns to provide improved client outcomes in terms of structure and function.                      Website: anatomytrains.com                        Email: info@anatomytrains.com             Facebook: facebook.com/AnatomyTrains                       Instagram: www.instagram.com/anatomytrainsofficial   YouTube: https://www.youtube.com/channel/UC2g6TOEFrX4b-CigknssKHA       Founded by a massage therapist for massage therapists, the Elements Massage brand is a network of independently-owned and operated studios dedicated to changing lives--including yours!  The Elements Massage brand believes massage therapists deserve a supportive team, business and marketing resources, and the chance to learn as much as they want, so many Elements Massage studios offer and reimburse continuing education on an ongoing basis. It's no surprise Elements Massage therapist and client satisfaction leads the industry. That's because from day one, the brand has kept an unmatched commitment to deliver the best therapeutic massage experiences possible for both clients and massage therapists. Elements Massage studios expects the best. So should you. If this sounds like a fit, reach out. Studios are  hiring!    Website: https://elementsmassage.com/ABMP Facebook: https://www.facebook.com/elementsmassage Instagram: https://www.instagram.com/elementsmassage Youtube: https://www.youtube.com/channel/UCXLHkAYMgmA6_MJ8DSEZm-A   Disclaimer: Each Elements Massage® studio is independently owned and operated. Franchise owners (or their designated hiring managers) are solely responsible for all employment and personnel decisions and matters regarding their independently owned and operated studios, including hiring, direction, training, supervision, discipline, discharge, compensation (e.g., wage practices and tax withholding and reporting requirements), and termination of employment. Elements Therapeutic Massage, LLC (ETM) is not involved in, and is not responsible for, employment and personnel matters and decisions made by any franchise owner. All individuals hired by franchise owners' studios are their employees, not those of ETM. Benefits vary by independently owned and operated Elements Massage® studios. Elements Massage® and Elements Massage + design are registered trademarks owned by ETM.   MYCO CLINIC stands at the forefront of natural pain relief and quality patient care.  Backed by 20 years of research and experience developing naturally derived topical products MYCO CLINIC was developed specifically for healthcare professionals and is available in moderate, extra strength and maximum strength formulas in a variety of sizes for in-clinic and home care solutions.   Product benefits include a smooth glide, no greasy residue, no medicinal smell and enhanced natural performance. All ingredients are clean, vegetarian or vegan-friendly, naturally sourced and/or USDA organic extracts. MYCO CLINIC products are manufactured in an FDA registered and cGMP audited facility to ensure the highest quality standards.   Try it today- get your free 10-pack sample of MYCO CLINIC ointment by visiting myco-clinic.com/get-free-samples/ 

What if self-care isn't about caring for the self but more about caring ABOUT the self? This is the self-care episode. In this episode, Allison defines the anatomy of care and what it means for you, your practice, and your clients. Host:                   Contact Allison Denney: rebelmt@abmp.com             Allison's website: www.rebelmassage.com                      Allison Denney is a certified massage therapist and certified YouTuber. You can find her massage tutorials at YouTube.com/RebelMassage. She is also passionate about creating products that are kind, simple, and productive for therapists to use in their practices. Her products, along with access to her blog and CE opportunities, can be found at rebelmassage.com.               This podcast sponsored by:     Rebel Massage Therapist: http://www.rebelmassage.com   Anatomy Trains: www.anatomytrains.com   Elements Massage: www.elementsmassage.com/abmp   MYCO CLINIC: www.myco-clinic.com     Rebel Massage Therapist: My name is Allison. And I am not your typical massage therapist. After 20 years of experience and thousands of clients, I have learned that massage therapy is SO MUCH more than a relaxing experience at a spa. I see soft tissue as more than merely a physical element but a deeply complex, neurologically driven part of who you are. I use this knowledge to work WITH you—not ON you—to create change that works. This is the basis of my approach. As a massage therapist, I have worked in almost every capacity, including massage clinics, physical therapy clinics, chiropractor offices, spas, private practice, and teaching. I have learned incredible techniques and strategies from each of my experiences. In my 20 years as a massage therapist, I have never stopped growing. I currently have a private practice based out of Long Beach, California, where I also teach continuing education classes and occasionally work on my kids. If they're good. website: www.rebelmassage.com FB: facebook.com/RebelMassage IG: instagram.com/rebelmassagetherapist YouTube: youtube.com/c/RebelMassage email: rebelmassagetherapist@gmail.com   Anatomy Trains is a global leader in online anatomy education and also provides in-classroom certification programs for structural integration in the US, Canada, Australia, Europe, Japan, and China, as well as fresh-tissue cadaver dissection labs and weekend courses. The work of Anatomy Trains originated with founder Tom Myers, who mapped the human body into 13 myofascial meridians in his original book, currently in its fourth edition and translated into 12 languages. The principles of Anatomy Trains are used by osteopaths, physical therapists, bodyworkers, massage therapists, personal trainers, yoga, Pilates, Gyrotonics, and other body-minded manual therapists and movement professionals. Anatomy Trains inspires these practitioners to work with holistic anatomy in treating system-wide patterns to provide improved client outcomes in terms of structure and function.                      Website: anatomytrains.com                        Email: info@anatomytrains.com             Facebook: facebook.com/AnatomyTrains                       Instagram: www.instagram.com/anatomytrainsofficial   YouTube: https://www.youtube.com/channel/UC2g6TOEFrX4b-CigknssKHA     Founded by a massage therapist for massage therapists, the Elements Massage brand is a network of independently-owned and operated studios dedicated to changing lives--including yours!  The Elements Massage brand believes massage therapists deserve a supportive team, business and marketing resources, and the chance to learn as much as they want, so many Elements Massage studios offer and reimburse continuing education on an ongoing basis. It's no surprise Elements Massage therapist and client satisfaction leads the industry. That's because from day one, the brand has kept an unmatched commitment to deliver the best therapeutic massage experiences possible for both clients and massage therapists. Elements Massage studios expects the best. So should you. If this sounds like a fit, reach out. Studios are  hiring!    Website: https://elementsmassage.com/ABMP Facebook: https://www.facebook.com/elementsmassage Instagram: https://www.instagram.com/elementsmassage Youtube: https://www.youtube.com/channel/UCXLHkAYMgmA6_MJ8DSEZm-A   Disclaimer: Each Elements Massage® studio is independently owned and operated. Franchise owners (or their designated hiring managers) are solely responsible for all employment and personnel decisions and matters regarding their independently owned and operated studios, including hiring, direction, training, supervision, discipline, discharge, compensation (e.g., wage practices and tax withholding and reporting requirements), and termination of employment. Elements Therapeutic Massage, LLC (ETM) is not involved in, and is not responsible for, employment and personnel matters and decisions made by any franchise owner. All individuals hired by franchise owners' studios are their employees, not those of ETM. Benefits vary by independently owned and operated Elements Massage® studios. Elements Massage® and Elements Massage + design are registered trademarks owned by ETM.   MYCO CLINIC stands at the forefront of natural pain relief and quality patient care.  Backed by 20 years of research and experience developing naturally derived topical products MYCO CLINIC was developed specifically for healthcare professionals and is available in moderate, extra strength and maximum strength formulas in a variety of sizes for in-clinic and home care solutions.   Product benefits include a smooth glide, no greasy residue, no medicinal smell and enhanced natural performance. All ingredients are clean, vegetarian or vegan-friendly, naturally sourced and/or USDA organic extracts. MYCO CLINIC products are manufactured in an FDA registered and cGMP audited facility to ensure the highest quality standards.   Try it today- get your free 10-pack sample of MYCO CLINIC ointment by visiting myco-clinic.com/get-free-samples/   

For most of us, seeing anatomy is the first step to understanding it. And anatomy understanding is an essential element of being a bodyworker. In this first episode of the three-part series “Your Practice in 3D,” we discuss the challenges of seeing the body in three dimensions and why so many massage therapists are heading to the dissection lab to study. Resources: Show Highlights: www.abmp.com/anatomy NYT Articles: https://www.nytimes.com/2023/12/13/well/move/cadaver-workshops-yoga-massage-therapy.html https://www.nytimes.com/2024/01/03/insider/from-the-pilates-studio-to-a-cadaver-dissection-lab.html​​ website: www.anatomyscapes.com FB: facebook.com/AnatomySCAPES IG: instagram.com/anatomyscapes YouTube: youtube.com/@anatomyscapes email: info@anatomyscapes.com   Hosts:   AnatomySCAPES Co-Directors, Rachelle Clauson and Nicole Trombley, are NCBTMB-approved continuing education providers and teach anatomy explorations for hands-on professionals online and in person. They co-author the Anatomy for Touch column in Massage & Bodywork magazine and enjoy helping therapists better understand how anatomy relates to what they are feeling through their sense of touch. Nicole Trombley: As a massage educator, Nicole draws on her passion for human biology to help therapists better understand the tissues under their hands. She owns and operates Equilibrio Massage in San Diego, CA, where she has specialized in massage for pregnancy and postpartum for the past 20 years. Rachelle Clauson: Rachelle loves teaching therapists about the structural organization and beauty of the human fascial system. She served as the Director of Creative and Administrative Affairs for the Fascial Net Plastination Project, and owns Flourish Bodywork, her private practice where she has offered hands-on bodywork in San Diego, CA, for the past 21 years.   Sponsors:   Elements Massage: www.elementsmassage.com/abmp   MYCO CLINIC: www.myco-clinic.com   Founded by a massage therapist for massage therapists, the Elements Massage brand is a network of independently-owned and operated studios dedicated to changing lives--including yours!  The Elements Massage brand believes massage therapists deserve a supportive team, business and marketing resources, and the chance to learn as much as they want, so many Elements Massage studios offer and reimburse continuing education on an ongoing basis. It's no surprise Elements Massage therapist and client satisfaction leads the industry. That's because from day one, the brand has kept an unmatched commitment to deliver the best therapeutic massage experiences possible for both clients and massage therapists. Elements Massage studios expects the best. So should you. If this sounds like a fit, reach out. Studios are  hiring!    Website: https://elementsmassage.com/ABMP Facebook: https://www.facebook.com/elementsmassage Instagram: https://www.instagram.com/elementsmassage Youtube: https://www.youtube.com/channel/UCXLHkAYMgmA6_MJ8DSEZm-A   Disclaimer: Each Elements Massage® studio is independently owned and operated. Franchise owners (or their designated hiring managers) are solely responsible for all employment and personnel decisions and matters regarding their independently owned and operated studios, including hiring, direction, training, supervision, discipline, discharge, compensation (e.g., wage practices and tax withholding and reporting requirements), and termination of employment. Elements Therapeutic Massage, LLC (ETM) is not involved in, and is not responsible for, employment and personnel matters and decisions made by any franchise owner. All individuals hired by franchise owners' studios are their employees, not those of ETM. Benefits vary by independently owned and operated Elements Massage® studios. Elements Massage® and Elements Massage + design are registered trademarks owned by ETM.     MYCO CLINIC stands at the forefront of natural pain relief and quality patient care.  Backed by 20 years of research and experience developing naturally derived topical products MYCO CLINIC was developed specifically for healthcare professionals and is available in moderate, extra strength and maximum strength formulas in a variety of sizes for in-clinic and home care solutions.   Product benefits include a smooth glide, no greasy residue, no medicinal smell and enhanced natural performance. All ingredients are clean, vegetarian or vegan-friendly, naturally sourced and/or USDA organic extracts. MYCO CLINIC products are manufactured in an FDA registered and cGMP audited facility to ensure the highest quality standards.   Try it today- get your free 10-pack sample of MYCO CLINIC ointment by visiting myco-clinic.com/get-free-samples/ 

Regulatory affairs teams have an outsized impact on business revenue, bringing new products to market quickly, managing registrations and licenses to keep products on the market, and staying updated on changing standards and regulations that might impact market clearance. Yet most regulatory affairs teams are treated primarily as operational cost-centers, resulting in poor productivity measurement, unclear objectives, and limited investments in people and technology.       During this podcast episode, we'll discuss why medtech companies should invest in their regulatory teams  Who is James Gianoutsos?  James Gianoutsos is the Founder & CEO of Rimsys Regulatory Management Software, a cloud-based solution to digitize, automate, and create regulatory order for MedTech companies. James is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. His professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. James also has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, MDR, MDSAP, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link James Gianoutsos LinkedIn:  https://www.linkedin.com/in/jwgianoutsos/  Rimsys website: https://www.rimsys.io/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice