Recalls make the headlines. But the real cost of poor quality never makes the press release — it hides in rework, investigations, remediation, and the launches that never happen.• The costs nobody puts on the recall announcement• Rework, investigations, and remediation: the real math• How poor quality taxes every future product launch• Making the business case for quality investmentNew episodes every Monday and Wednesday — follow The GMP Insider so you never miss one.Connect with Tushar Arora on

In this classic episode of Weirdhouse Cinema, Rob and Joe discuss the 1988 horror comedy creature feature Killer Klowns From Outer Space, produced by the Chiodo brothers and starring Grant Cramer, Suzanne Snyder, John Allen Nelson and John Vernon. (originally published 10/3/2025)See omnystudio.com/listener for privacy information.

21 CFR Part 4 sets the CGMP requirements for combination products. If your product has a drug and a device in it, you're on the hook for both sets of regulations. In this video, I walk through Part 4 Subpart A section by section: the scope, the key definitions, which CGMPs apply, and the two ways to comply, including the streamlined approach under 4.4(b).Updated for February 2026, when the device side moved to the QMSR and ISO 13485, plus the new medical gas provisions.Working on your first

In this episode of The BioHub by Avetix, I’m joined by Eran Seger, CEO and Co-Founder of Protai.Eran shares his unique journey into biotech and the inspiration behind founding Protai, where the team is combining proteomics and AI to better understand disease biology and improve how new medicines are discovered.We discuss what makes Protai’s platform different, the realities of being a first-time founder and CEO, the challenge of bringing technology and biotech teams together, and where Eran believes

Trays are piling up. Staffing is stretched thin. Quality issues keep popping up. When everything feels urgent, how do you know what to tackle first? In this episode of "Lead with Confidence," Betty Casey from Surgical Solutions breaks down how data can help Sterile Processing leaders cut through the noise and make more confident, informed decisions. Whether it's tracking tray backlogs, improving scanning compliance, identifying workflow gaps, or getting your team invested in the numbers, Betty

Planetterrian Daily🌍 Planetterrian Daily - Science, Longevity & Health Discoveries A protein known as the glue holding cells together also helps epithelial cells swallow dead neighbors in zebrafish and mouse embryos. Top 15 Science & Health Discoveries ... Sources: sciencedaily.com · reddit.com · phys.org · smallcaps.com.au · directorstalkinterviews.com · dongascience.com AI Disclosure: This podcast is curated by Patrick but uses AI-generated voice synthesis for audio production. 🎬 Watch on

Dr. Beth Shapiro, PhD, is an evolutionary biologist and Chief Science Officer at Colossal Biosciences. Her work focuses on de-extinction and wildlife conservation efforts. We discuss genetic differences among humans, and how ancient DNA and modern embryology are being used to de-extinct and protect woolly mammoths, dodo birds, and dire wolves, as well as to help conserve endangered species. We also explore the ethical implications of de-extinction and how synthetic biology can help build a more bio

We’re easing you into Halloween season with an episode about bats. There’s a silent serial killer decimating little brown bats as they hibernate. White nose syndrome has driven populations across the U.S. to almost the brink of extinction over the last decade. But recently, conservation biologist Giorgia Auteri and her team noticed several genetic mutations in the survivors. These mutations could explain how natural selection has shifted the existing population – and inform conservation efforts in

AI Success Foundations for Pharma 4.0Artificial intelligence has the potential to transform pharmaceutical R&D, manufacturing, quality, clinical development, and the broader healthcare value chain. But successful AI adoption in pharma does not begin with sophisticated algorithms—it begins with strong foundations. In this episode of Center of Excellence - Pharma 4.0, we explore the AI Success Foundation Framework for Pharma 4.0 and examine what pharmaceutical organizations need to establish

Host Joe Patterson, MD chats with JOT paper author Arun Aneja, MD about the JOT published article: "High Rate of Missed Geriatric U-Type Sacral Fractures Despite Advanced Imaging: A Retrospective Case Series"  Click the link to see the publication.

Bienvenidos a IMPACTO,Elsa Morales Roth conversa con  Rosa Olascoaga-Vidal, jefa de gabinete del Distrito 9 de la Ciudad de San Diego, sobre cómo una joven de City Heights se convirtió en una voz clave de las políticas públicas locales. Rosa empezó a organizarse a los 12 años, después de que un auto atropellara a su hermano mientras patinaba, y logró que se construyera un parque de patinaje en su comunidad con el apoyo de la Tony Hawk Foundation y The California Endowment. Cuenta también cómo, tras

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Unsere Augen verändern sich mit dem Alter, doch vieles lässt sich durch Vorsorge und einen bewussten Umgang mit den eigenen Augen positiv beeinflussen. In dieser Folge des Hörgangs spricht Priv.-Doz. Dr. Domagoj Ivastinovic von der Universitäts-Augenklinik der Med Uni Graz darüber, welche Veränderungen normal sind, welche Augenerkrankungen im Alter besonders häufig auftreten und bei welchen Warnzeichen rasches Handeln gefragt ist. Außerdem erklärt er, was regelmäßige Kontrollen bringen und welche

In this episode, we sit down with Mark Olly: author, television presenter, archaeologist, musician, producer, artist, and public speaker. Known for his appearances on Ancient Aliens and his series Lost Treasures, Mark brings a real-life Indiana Jones spirit to exploring the past. His travels have taken him to some of the world’s most fascinating ancient sites—places that continue to inspire questions thousands of years later. From Egypt’s ancient landscapes to the mysteries of Chichén Itzá, M...

The Pharma Closeout's ASTRO 2026 Debrief covers the readouts from the American Society for Radiation Oncology meeting that matter for drug,diagnostic and payer strategy. Fourteen-year RTOG 0815 data re-open how much hormone therapy men need with prostate radiation, as Veracyte's Decipher andArtera compete to decide who can skip it. The NRG-GI003 plenary showed no survival improvement for protons over photons in liver cancer, Novocure's TRIDENT timing trial missed, and new data arrived on

There’s a lot of current hype around AI, it’s abilities but also the potential threat that it poses to humanity. The standard narrative sounds like a sci-fi movie, one of these systems is on the verge of waking up and taking over the whole world and has been for at least the last five years. In this episode we take a skeptical look at AI, the current state of the art, the history and development of these systems, examples of AI outside of LLMs. And take a close look at the argument that AI is about

今回は10月の「科学系ポッドキャストの日」参加回です！テーマは「におい」、ホストは「プラントライフ」さんです。アリ一匹の脳は、神経細胞わずか25万個ほど。人間の脳(約860億個)と比べると30万分の1程度のサイズしかありません。それなのにコロニー全体になると、まるで一つの知性を持った生き物のように、驚くほど高度な社会を作り上げてしまいます。 その秘密は、フェロモンという”化学の言語”にありました！道案内、非常警報、女王による生殖の統制、そして仲間と敵の識別まで、アリはすべてを匂いでやってのけています。さらに近年の研究では、匂いだけでなく、音や振動によるもう一つの言語も持っている可能性が報告されています！ 【今回のハイライト】 ・アリの脳は神経細胞25万個、それでも昆虫界トップクラス ・ハキリアリの菌類農業、ミツツボアリの”生きた貯蔵庫” ・アリ研究の巨人エドワード・O・ウィルソンとデュフォア腺の実験 ・道しるべフェロモン、警報フェロモン、女王フェロモンの働き ・体表の匂いによる仲間識別と、居候昆虫クロシジミの化学的ななりすまし ・岡山理科大学 ・

Episode SummaryA client sent Mikki a link to a very flash Withings bioelectrical impedance scale — NZ$819, marketed as 99% as accurate as a DEXA scan — and asked the obvious question: is it worth the money? In this solo episode Mikki goes and reads the validation document behind that claim, and finds the problem isn't really the scale at all. It's a statistical sleight of hand that turns up constantly in health tech marketing: reporting a correlation and calling it accuracy.Mikki explains

Bu bölümde, Japonya'nın İlaç ve Tıbbi Cihazlar Ajansı'nın (PMDA) 18 Eylül 2026'da Tıbbi Cihaz Olarak Yazılım (SaMD) için yayınladığı önemli güncellemeleri inceliyoruz. Revize edilen kılavuz, yeni seminer materyalleri ve güncellenen danışmanlık takviminin, Japonya pazarına girmeyi hedefleyen üreticiler için ne anlama geldiğini ayrıntılı olarak ele alıyoruz. Yapay zeka, siber güvenlik ve yaşam döngüsü yönetimi gibi kritik alanlardaki yeni beklentileri ve başarılı bir başvuru için atılması gereken

Den 18 september 2026 uppdaterade Japans PMDA sin vägledning för programvara som medicinteknisk produkt (SaMD). Detta avsnitt analyserar de viktigaste förändringarna i den reviderade guiden, vad det nya seminariematerialet avslöjar om PMDA:s förväntningar på ansökningar, och den strategiska inverkan av den uppdaterade konsultationstidsplanen för tillverkare som siktar på den japanska marknaden.Key Questions: - Vilka är de viktigaste ändringarna i PMDA:s reviderade vägledning för SaMD? - Hur