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A Ropes & Gray (RopesTalk) podcast series, focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry.
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RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.
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Ropes & Gray attorneys provide timely analysis on legal developments, court decisions and changes in legislation and regulations.
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Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do. We focus on life science issues ...
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Welcome to Food Tech Talk: Supply Chain Insights From Farm to Fork, a bite-sized podcast discussing the latest trends and technology in the food and supplements industries, featuring conversations with regulatory experts, quality and safety champions, and thought leaders across the industry. Together, we are on a mission to change the food and dietary supplement industry for the better. In short snippets, guests will discuss a range of topics, from regulatory compliance to sustainable operat ...
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Welcome to The Sidley Podcast. Join us as we bring a unique perspective to complex issues at the intersection of law and business.
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With hemp being legalized only recently, legal and regulatory regimes concerning the crop and its products such as CBD are continually evolving. Jonathan Miller, who helped craft much of federal and state hemp laws in his role as General Counsel of the US Hemp Roundtable, hosts a biweekly podcast in which he engages in 15-20 minute discussions of cutting-edge legal issues facing the industry. Jonathan speaks on each program with subject matter experts from Frost Brown Todd’s nationally leadi ...
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FDA Watch is a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. The podcast focuses on four core areas: pharmaceuticals and biologics; medical devices and diagnostics; food and dietary supplements; and cosmetics and personal care products, as well as on the overall direction of FDA regulation. The podcast also will have bonus episodes to cover breaking news. Podcast gue ...
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Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.
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A Ropes & Gray (RopesTalk) podcast series focused on the world of unfair import investigations at the U.S. International Trade Commission (ITC).
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From the trusted team behind the Tuttle Twins books, join us as we tackle current events, hot topics, and fun ideas to help your family find clarity in a world full of confusion.
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FDA Imports
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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Co -hosted by Glenn Hunzinger, US Health Industries leader, and Jennifer Colapietro, Consulting Commercial Leader, the Next in Health podcast series offers insights on the most important issues facing pharma, medtech and healthcare. PwC business leaders discuss the latest trends and their impact on health industries, whether it’s policy, AI, innovation, care delivery, business model reinvention or bold moves for the future. If it’s happening in health industries, we’re talking about it.
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Anesthesiology News will be publishing a new season of our popular podcast series, “On the Case” and “Ask the Experts.” “On the Case” is a review series that features the authors of our popular case report series. We hear the behind-the-scenes story on the most unique clinical case studies published in the magazine directly from the professionals who managed them. The first episode of this new season features an interview with L. Jane Stewart, MD, JD, MPH, who co-wrote a case report about a ...
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The $1 Pound Show dives deep into the cannabis industry. We discuss and document the transition happening with marijuana. From the black market to grey market finally to a regulated market. California has recently legalized cannabis and is currently figuring out it's regulations. Guests include, cultivators, extractors, lawyers, doctors other business owners.
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I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues is a legal podcast hosted by Arnall Golden Gregory LLP. In this podcast series, different members of our Food & Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal matters.
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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to li ...
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16 Minutes on the News is a short news podcast where we cover the top headlines of the week, the a16z podcast way -- why are these topics in the news; what's real, what's hype from our vantage point; and what are our experts' quick takes on these trends? About the a16z Podcast: Discusses tech and culture trends, news, and the future -- especially as ‘software eats the world’. It features industry experts, business leaders, and other interesting thinkers and voices from around the world. This ...
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On the "Making it to Market" podcast, we discuss everything about brand inception and product/service creation through to commercialization. Industry experts and business owners are invited to share their insights and best practices related to business planning, legal and regulatory considerations, manufacturing, supply chain, marketing, merchandising, B2B buyer methodology and B2C consumer psychology.
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Trends in False Advertising and Related Competitor Disputes Involving FDA-Regulated Products
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On this special collaborative episode of Ropes & Gray's Non-binding Guidance and Talkin’ Trade podcast series, life sciences regulatory and compliance partner Josh Oyster is joined by intellectual property litigation partner Matt Rizzolo to discuss the complex world of false advertising and unfair competition disputes involving drugs, medical devic…
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Non-binding Guidance | Talkin' Trade: Trends in False Advertising and Related Competitor Disputes Involving FDA-Regulated Products
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On this special collaborative episode of Ropes & Gray's Non-binding Guidance and Talkin’ Trade podcast series, life sciences regulatory and compliance partner Josh Oyster is joined by intellectual property litigation partner Matt Rizzolo to discuss the complex world of false advertising and unfair competition disputes involving drugs, medical devic…
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589. Should The FDA Regulate What We Eat?
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What is the propert role the FDA should play in regulating what we consume? Rachel and Brittany discuss.
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7 Must-Know Steps to transfer medical device ownership
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Transferring medical device ownership during a company sale requires careful planning to ensure compliance and operational continuity. The process begins with accurate documentation of 510(k) clearance and thorough due diligence to avoid regulatory delays. Next, companies must assess ongoing clinical trial responsibilities and contractual obligatio…
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Navigating the FDA disruption: 4 key actions for pharma
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Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, connects with Matt Rich, PwC’s Pharma and Life Sciences R&D Leader, to unpack the recent disruption at the FDA and what it means for the pharmaceutical and biotech sectors. They discuss how companies can stay agile in the face of regulatory uncertainty, avoid preventable delays, and take p…
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Strategic Shifts: Navigating China's Biotech Boom and Its Impact on US Pharma
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Tune in as Glenn Hunzinger, PwC’s Health Industries Leader and Roel van den Akker, PwC’s Pharma and Life Sciences Deals Leader discuss the rapid rise of China’s biotech industry and what it means for U.S. pharmaceutical companies. They discuss the evolving role of Chinese biotech in the global innovation landscape and share perspectives on how U.S.…
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At first glance, responding to site-level findings seems simple—but when Edye and Darshan dug into the details, it became clear that the lines of responsibility blur fast. Here's how each side sees it: Site Perspective: Sites know the boots-on-the-ground reality. When a finding is made—especially during an external inspection like the FDA—they’re o…
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189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?
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Ever wondered who’s really behind the regulations you follow in pharma and medical devices? In this episode of Let’s ComBinate, Subhi Saadeh breaks down the five categories of organizations that influence how we develop, test, and release products:Regulatory Authorities (like FDA, EMA, PMDA)Harmonization Bodies (like ICH, IMDRF, and PIC/S)Standards…
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Medical communications teams must exercise caution when using websites dedicated to medical affairs, as legal risks go beyond overt sales promotion. Drug and device manufacturers face compliance challenges, particularly when these platforms are accessed by broader audiences, including non-scientists. Key risks include: Off-Label Promotion: The Fact…
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Anthony Newby and Justice in Cannabis and Hemp
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Jonathan Miller interviews Anthony Newby, CEO of Cultivated CBD, about issues of justice and equality in the hemp and cannabis industries. If you have questions about the episode or ideas for Hemp related topics, email us at [email protected]. Hemp Industry questions covered in the episode: Why have the hemp and cannabis industries bee…
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Homing in on Food Supply, Tariffs & Infant Formula
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Shelly and Wayne chat with Martin Hahn, Global Regulatory Partner at Hogan Lovells, and Tony Pavel, Partner at Keller and Heckman. You’ll hear their thoughts on global food supply chain vulnerabilities and how FDA is monitoring them; how U.S. tariffs on imported food products influence the availability and safety oversight of essential goods like f…
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At the Save Our Sites (SOS) conference, many site owners expressed excitement over finally having a space to openly discuss real challenges—budgets, pricing, contracting, and the isolation of being a site owner. While the intent was mutual support, concerns quickly arose when some attendees began advocating for standardized pricing across sites (e.…
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The recent conviction of a Michigan pharmacist and his brother in a $15 million healthcare fraud scheme highlights the growing crackdown on pharmacy-related fraud. The scheme involved billing for medications that were never dispensed, targeting Medicare, Medicaid, and private insurance. This pattern of fraud is not new, as the Department of Justice…
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594. What Is The Difference Between The Rule of Law and The Rule of Men?
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Why we need rules and why the Constitution is important for the government to follow.
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If you want to be successful in your life, it's important to recognize the importance of ditching your ego.
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Culture & Compliance Chronicles: Emotionally Charged Leadership with Dina Denham Smith
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On this episode of Culture & Compliance Chronicles, Amanda Raad and Nitish Upadhyaya from Ropes & Gray’s Insights Lab, and Richard Bistrong of Front-Line Anti-Bribery, are joined by Dina Denham Smith, an accomplished leader, executive coach, and author, to discuss her new book, Emotionally Charged: How to Lead in the New World of Work. Dina shares …
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188 – Certified Quality Auditor(CQA) and Audits in the Future
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In this episode of Let’s Combinate, Subhi Saadeh—an ISO 13485 certified lead auditor, CQA, and CQE—dives into the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his journey to becoming a Certified Quality Auditor and asks a timely question: in the age of AI, will audits—and auditors—still matter? Subhi…
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503 Compounding: Challenges, Compliance & the Road Ahead
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In this episode of RCA Radio, host Brandon Miller is joined by RCA experts Anita Michael and Arie Anahory for a deep dive into the evolving world of compounding pharmacies. Together, they explore the critical role compounders play in personalized medicine, their differences from traditional pharmaceutical manufacturers, and the increasing regulator…
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Pharma is finally catching up to the on-demand world—offering direct-to-patient (DTP) services that promise convenience, faster delivery, and a more personalized experience. Major players like Pfizer, Lilly, and Novo Nordisk are leading the way, cutting out intermediaries like pharmacists, PBMs, and even traditional physicians. But convenience come…
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How to Build an Unshakable Food Safety Culture Without Perfect Systems with Dom Mitial
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In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams sits down with Dom Mitial, VP of Food Safety, Quality, and Regulatory at Goldbergs Group, to discuss how to build a strong food safety culture while driving business growth. Dom shares practical strategies for fostering cross-functional collaboration, gaini…
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Today, we're diving into a hot topic in clinical trials: should you use AI to negotiate your next clinical trial agreement? Darshan is joined by Elizabeth from the University of Cincinnati and Istvan Fekete from Huron Consulting, who share their experiences and thoughts on using AI for contract and budget negotiations. They discuss the potential an…
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In this discussion, Edye Edens and Darshan Kulkarni tackle one of the most common questions in clinical research: How many SOPs should a site have? While many assume a fixed number like 12, the reality is more nuanced. From a site perspective, having extensive SOPs can feel overwhelming, but they are essential for compliance and audits. SOPs are th…
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1
Trends in False Advertising and Related Competitor Disputes Involving FDA-Regulated Products
17:55
17:55
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17:55
On this special collaborative episode of Ropes & Gray's Non-binding Guidance and Talkin’ Trade podcast series, life sciences regulatory and compliance partner Josh Oyster is joined by intellectual property litigation partner Matt Rizzolo to discuss the complex world of false advertising and unfair competition disputes involving drugs, medical devic…
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592. What happens when a business goes bankrupt?
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Should failing businesses be bailed out? Here's why not. A lemonade stand story.
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A Murdered CEO, Anesthesia Reimbursement (Almost) Restricted and Ubiquitous Corporate ‘Greedflation’: Signs of the Times?
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A healthcare company executive is shot in the back, murdered in cold blood; an angry populace chafes at the rising costs of health insurance and denials in coverage; and a privately held insurance company schemes to fatten its bottom line by restricting reimbursement for anesthesia services. In the parlance of that god-awful, hackneyed expression, …
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Should justice be the same for everyone? Or is should it be applied differently to different people?
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R&G Tech Studio: AI Innovation vs. Safety—Insights on a New Executive Order
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On this episode of the R&G Tech Studio podcast, Ropes & Gray partners and co-leaders of the firm’s AI initiative, Megan Baca and Ed McNicholas, delve into the key implications of President Trump’s new AI Executive Order 14179, contrasting it with the previous Biden administration's approach to AI regulation. They explore the nuances of AI innovatio…
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In a recent interview between Nirpal Virdee and Darshan Kulkarni, they discussed the ongoing shifts in the pharmaceutical industry, particularly the rise of Direct-to-Patient (DTP) models. The conversation explored how these changes are driven by the pressure to reduce drug and device costs, especially in light of new tariffs that could further esc…
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187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)
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What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products? In this episode of Let’s Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical devi…
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Hackers Are Stealing Your Personal Health Data
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Health records are one of the top targets for hackers. These records contain a wealth of personal information like Social Security numbers, insurance details, and medical history, making them a gold mine for cybercriminals. Hackers use this data to steal identities, open credit cards, and even file fake tax returns. The scariest part? They can crea…
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Brandon Pollock and the Transition from Marijuana to Hemp
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Jonathan Miller interviews Brandon Pollock, CEO of Theory Wellness, about how more marijuana companies are getting into the business of hemp. If you have questions about the episode or ideas for Hemp related topics, email us at [email protected]. Hemp Industry questions covered in the episode: How are marijuana companies navigating the…
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590. Why Should Health Care Be More Like Restaurants?
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Choice and competition makes every product better. Healthcare is no different. But with the structure of the medical industry today, our choices are increasingly made for us and we're left with what government has approved and what insurance will cover. Are we getting healthier this way?
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How a “Medical Education” Program Became a $202M Fraud
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We unpack the $202 million storm surrounding Gilead’s so-called “educational” speaker programs — and why it should make every medical affairs, legal, marketing, and compliance professional sit up straight. Here’s what happened: The DOJ alleged that Gilead turned 17,000 speaker programs into a covert marketing machine to boost HIV drug prescriptions…
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Webinar Recap: What Sponsors Must Know About Fraud
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After our first-ever deep dive webinar on ‘Protecting Sponsors, Fraud & Compliance in Research,’ Darshan Kulkarni, Edye Edens, and Nirpal Virdee sat down to reflect on what turned out to be a high-impact and incredibly timely conversation. Nirpal (the newest face on the team, leading business development) shared how exciting it was to finally launc…
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AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development
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In this second part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Howard Sklamberg, Partner at Arnold & Porter; Eva Temkin, Partner at Arnold & Porter; and Marko Topalovic, Chief AI Officer at Clario, which recently acquired ArtiQ, where he was Founder and CEO. Together, they discuss how AI can accelerat…
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Multidimensional Data Reversion: Harnessing Analytics and Visualization
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On this second episode of Ropes & Gray’s Insights Lab’s four-part Multidimensional Data Reversion podcast series, Shannon Capone Kirk, managing principal and global head of Ropes & Gray’s advanced e-discovery and AI strategy group, is joined by David Yanofsky, director of data insights, analytics and visualization at the R&G Insights Lab. Together,…
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186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech
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In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career professionals. The tips include: publishing early to build visibility, understanding how industry regu…
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R&G Tech Studio: Navigating AI Literacy—Understanding the EU AI Act
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On this episode of the R&G Tech Studio podcast, Rohan Massey, a leader of Ropes & Gray’s data, privacy and cybersecurity practice, is joined by data, privacy and cybersecurity counsel Edward Machin to discuss the AI literacy measures of the EU AI Act and how companies can meet its requirements to ensure their teams are adequately AI literate. The c…
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AI voice tech might be the next big privacy risk for pharma marketers, and lawsuits are already in motion. In this episode of Darshan Talks, we dive into the legal challenges surrounding AI-powered voice tools in healthcare marketing, especially under California’s strict privacy laws. A federal court ruling in Ambrose v. Google suggests that record…
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Tariffs Expected to Worsen Shortages, Increase Drug Prices and Hurt Healthcare
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From never-ending staffing shortages to a myriad of financial challenges from the COVID-19 pandemic, the past several years have been exceptionally difficult on the United States' healthcare system. Although many institutions have weathered the storm, some have resorted to private equity, some are on life support and others have closed their doors.…
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The AI Revolution in Food Safety: Why 2025 Will Change Everything | Steve Warwick
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In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams interviews Steve Warwick, Head of Technical at Bulk, discussing the evolution of food safety practices, allergen management, and the impact of e-commerce on quality control in the food industry. The conversation covers the importance of building robust HACC…
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Pharmaceutical Imports, Commerce & CBP Tariffs & that dreaded number: “232”
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Episode Summary: In this episode, Benjamin L. England discusses recent developments in pharmaceutical imports, commerce, and CBP tariffs, particularly focusing on Section 232 investigations and reciprocal tariffs. The conversation covers the Department of Commerce's role in regulating international trade and its recent investigation into pharmaceut…
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Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Pierre Stanislawski, our IDMP expert, and Josh Keliher, who’s leading the charge on AI at Ennov. Together, we dive into two major questions: what does AI really mean for regulatory a…
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Shelly and Wayne chat with Dr. Daniel Schultz, Principal of Medical Devices and Combination Products at Eliquent, and Jonathan Kahan, a Global Regulatory Partner at Hogan Lovells. You’ll hear their thoughts on the effect of CDRH staff reductions on medical device reviews and market authorizations; the outlook for device regulation in the next few y…
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Webinar Update: Fraud Prevention Strategies Every Sponsor Needs
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Event details- https://www.linkedin.com/events/protectingsponsors-fraudandcomp7318667647213002752/comments/ Registration Link- https://us02web.zoom.us/meeting/register/KhsVL6C6Tg6KKNDRHYTEKA In this kickoff conversation, Darshan Kulkarni and Edye Edens introduce a candid new series exploring how legal and compliance professionals approach clinical …
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588. Why do ethics matter in a free society?
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For optimal self-governance, people need to govern themselves. That is why culture and morality matter. If you can't keep yourself from hurting others and taking their stuff, the government has to step in. For limited government, culture matters.
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Are Your Promotional Claims Putting Your Company at Risk?
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Guardant Health’s recent $292 million victory against Natera in a false advertising lawsuit sets a critical precedent for the biotech industry, highlighting the severe consequences of misleading claims. This case is a wake-up call for drug and device companies navigating complex FDA and FTC regulations. False advertising not only misleads stakehold…
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Navigating Healthcare’s Next Chapter Under the Trump Administration
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Disclaimer: This episode was recorded on April 11th, 2025, and reflects the information available at the time of recording. As we know, America is in motion here, and so subsequent updates may not be reflected in this discussion as things continue to evolve and change. Tune in as PwC specialists from across the health industry share their insights …
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185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder
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In 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 regula…
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Getting Your Head Around the UK’s New (and Globally Relevant) “Failure to Prevent Fraud” Offence
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On this Ropes & Gray podcast, join Amanda Raad, co-head of the firm’s global anti-corruption and international risk and crisis management & investigations practices, Nitish Upadhyaya, director of behavioral insights at the R&G Insights Lab, and Sarah Lambert-Porter, a senior attorney in the litigation & enforcement practice, as they explore the sig…
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