show episodes
 
Artwork

1
RCA Radio

Regulatory Compliance Associates

Unsubscribe
Unsubscribe
Havi
 
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.
  continue reading
 
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 ...
  continue reading
 
Artwork

1
Hemp Legally Speaking

Jonathan Miller - National Leading Hemp Attorney & Advocate

Unsubscribe
Unsubscribe
Havi
 
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 ...
  continue reading
 
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 ...
  continue reading
 
RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing. RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ t ...
  continue reading
 
This Food Industry focused podcast brings together Xtalks editorial staff to share insights into the latest B2B industry news. Xtalks connects professionals in the life science, medical device, and food industries with useful content like webinars, job opening, articles and virtual meetings.
  continue reading
 
Artwork

1
$1 Pound Show

CannabisPermits.com

Unsubscribe
Unsubscribe
Havi
 
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.
  continue reading
 
Our goal in this podcast is to support natural product brands, dietary supplement companies, functional food and beverage companies, and nutraceutical industry professionals by offering interviews with top industry experts. These interviews will contain best practices, trends, recent news, and other insights as they relate to business ops, supply chain, quality, science and regulatory, manufacturing, marketing, strategy, branding and more.
  continue reading
 
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 ...
  continue reading
 
Loading …
show series
 
In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pertinent to combination products. Sue comprehensively outlines the regulatory frameworks governing each process—ICH Q10 for drug transfer and ISO 13485 for device design transfer. The episode discusses…
  continue reading
 
In this episode of Food Tech Talk, Lydia Adams speaks with Eric Moore about the evolution of digital food safety management systems. Eric shares his unexpected journey into food safety, beginning in the early 2000s when he transitioned from hospitality management to becoming a designated food safety professional at the Pennsylvania Convention Cente…
  continue reading
 
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧗‍♀️ Our newest 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview is an especially fun one! From National Geographic subscriptions to successfull…
  continue reading
 
Jonathan Miller interviews Aaron Nosbisch, the CEO of Brez, about the exciting new category of hemp beverages, the challenges and the opportunities. If you have questions about the episode or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.com. Hemp Industry questions covered in the episode: What are the factors behind the rec…
  continue reading
 
In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems. Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions…
  continue reading
 
In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t provide much information. So, let’s review that together. Who is Adam Isaacs Rar? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsm…
  continue reading
 
In this episode of RCA Radio, host Brandon Miller is joined by Nelson Labs Director of E&L Raymond Colton as well as board certified toxicologist Dr. Sarah Campbell also from Nelson Labs to discuss the recent draft FDA GUIDANCE DOCUMENT: Chemical Analysis for Biocompatibility Assessment of Medical Devices. Listen in as we cover why this guidance wh…
  continue reading
 
In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion, they highlight the independence of quality units to prevent conflicts of interest, drawing parallels with finance and HR functions. The…
  continue reading
 
On this episode of Ropes & Gray’s podcast series, Non-binding Guidance, life sciences regulatory and compliance partner Greg Levine and counsel Beth Weinman are joined by appellate and Supreme Court practice head Doug Hallward-Driemeier to explore the Supreme Court's recent landmark decision in Loper Bright, which ended the long-standing practice o…
  continue reading
 
*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.* In the final installment of this three…
  continue reading
 
This presentation and panel was recorded 4 October 2024. We encourage you to download the slides presented during this session by ⁠⁠⁠⁠⁠⁠⁠completing the form on this page⁠⁠⁠⁠⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in a…
  continue reading
 
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation. Simon breaks down NEST's critical role in catalyzing the use of RWE to stre…
  continue reading
 
in this episode, Georg Digel will help use solve 3 major problems with our CAPAs. He will tell you what these problems within your Quality Management System are and propose some solution. We will also talk about the education of the team. Who is Georg Digel? I’ve reviewed too many Medical Device CAPAs over the last 10 years. I think I’ve seen almos…
  continue reading
 
In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achieved. The episode highlights the importance of consistency in podcast production, inspired by Robert Greene's 'Mastery,' and outlines plans for the show's future evolution.00:00 Welcome and Podcast Jo…
  continue reading
 
Join Lydia Adams as she speaks with Chris Latta, Director of Business Development at Kwik Lok, about the evolving landscape of food traceability and transparency. With over 15 years of experience in global sales, marketing, sustainability, and industrial design, Chris brings a unique perspective to the conversation. Chris discusses Kwik Lok's 70-ye…
  continue reading
 
*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.* In part two of a three-part series, Jais…
  continue reading
 
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. ⭐ After highlighting many members of our Jordi Labs, an RQM+ Company team in the past two months, we're returning to RA/QA thi…
  continue reading
 
Jonathan Miller interviews Boone Cutler, the chairman of Spartan Sword, a veterans’ advocacy organization, about continuing battles our nation’s veterans face in ensuring access to hemp and CBD products for health and wellness purposes. If you have questions about the episode or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.…
  continue reading
 
*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.* In part one of a three part series, Jaisha…
  continue reading
 
In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices. The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these …
  continue reading
 
Medboard: https://www.medboard.com/ EUROPE TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf MDCG…
  continue reading
 
In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development. Chuck highlights how poor design inputs can slow down product development and lead to issues in market compliance. He stresses the importance of spendin…
  continue reading
 
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 Our run of 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interviews with our Jordi Labs, an RQM+ Company team members continues with Christine Santag…
  continue reading
 
In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings. They explore how home use devices, su…
  continue reading
 
In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this. Who is Lucas Pianegonda? Lucas Pianegonda is an expert for medical grade plastics, material testing and materi…
  continue reading
 
*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.* 🚨 Watch our newest video to learn best pract…
  continue reading
 
On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman, highlights the differences in regulatory oversight and risk management between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the chall…
  continue reading
 
Join Lydia Adams on Food Tech Talk as she interviews Steven Foster, a seasoned expert in food safety and quality assurance with over 30 years of experience in the food industry. Currently serving as the VP of Food Safety and Quality at Wholesale Produce Supply, Steven shares his journey and the defining moments that shaped his approach to food safe…
  continue reading
 
*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.* In our latest clinical trials video, Manager o…
  continue reading
 
This presentation and panel was recorded 12 September 2024. We encourage you to download the slides presented during this session by ⁠⁠⁠⁠⁠⁠completing the form on this page⁠⁠⁠⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in …
  continue reading
 
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality …
  continue reading
 
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues as Christine Santagate, RAC chats with Dr. Anthony Grice, a leading chem…
  continue reading
 
On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie…
  continue reading
 
In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US. Who is Claire Dyson? Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery …
  continue reading
 
In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development. Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuri…
  continue reading
 
The landscape of publicly traded food companies is constantly evolving, with consumer preferences, technological advancement and global challenges all playing a role in shaping the industry. In 2024, these factors have culminated in a diverse and competitive market where the largest publicly traded food companies dominate. In this episode of the Xt…
  continue reading
 
On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma en…
  continue reading
 
In this episode of Food Tech Talk, Lydia Adams sits down with Dr. Stephen Sims, a distinguished food safety and quality assurance expert. With a background in chemistry and extensive experience in the food industry, Dr. Sims offers unique insights into the world of food safety auditing and quality management. Dr. Sims takes us through his journey f…
  continue reading
 
In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right. Who is Cesare Magri? Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diag…
  continue reading
 
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues this week, as Christine Santagate, RAC is joined by Lab Coordinator Crai…
  continue reading
 
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 Our 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 interview series continues this week, as Christine Santagate, RAC is joined by Chemist II Michael M…
  continue reading
 
In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development. They discuss how DOE can be used to better understand systems, reduce risk, and solve complex problems, especially in R&D and manufacturing processes. Perry shares insights from h…
  continue reading
 
On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system…
  continue reading
 
Loading …

Gyors referencia kézikönyv