Podcasts about Quality assurance

In this engaging conversation, Heath Shearon and Alex Rodov explore the vibrant culture of Toronto, the evolution of technology and quality assurance, and the critical role of testing in the insurance industry. Alex shares his journey from humble beginnings to becoming a leader in the tech space, emphasizing the importance of methodology and the pressures faced in quality assurance. They discuss the challenges of trusting technology, the significance of consumer education, and the future of QA technology, including Alex's new book on testing.TakeawaysGrowing up in Toronto inspired Alex's passion for technology.Quality assurance has evolved significantly over the years.Pressure in QA is a constant, especially in critical industries.Methodology is essential for effective software testing.Consumer education is vital for understanding technology's reliability.The insurance industry heavily relies on quality assurance processes.Alex's book aims to educate consumers about testing.Investing in QA technology is crucial for future advancements.Chapters00:00 Exploring Toronto: A Cultural Hub06:03 The Evolution of Quality Assurance in Tech13:48 The Importance of Methodology in QA22:02 The Role of QA in the Insurance Industry30:12 Investing in the Future of QA TechnologySponsors:Smart Choice- the fastest growing agency network hands down Canopy Connect- your 1 click solution for all things dec pages, intake platforms etc MAV- the AI-powered insurance expert that engages unlimited leads with text messaging 

On this episode, host Katy Starr chats with Greg Hammond, Standlee's Director of Operations, to learn more about what it takes to turn premium western hay into the consistent, high-quality forage your animals depend on, including:What the Standlee Performance System is and how it drives efficiency and qualityTechnology and checks that protect product consistency and safetyWhat horse and livestock owners should know about how their hay products are made, from the field to the shelfGreg also talks about the strong sense of purpose his team feels, knowing their attention to detail and commitment to quality directly support the health of horses and livestock across the country.

Welcome to RIMScast. Your host is Justin Smulison, Business Content Manager at RIMS, the Risk and Insurance Management Society.   In this episode, Justin interviews Julia Anna Potts, President and CEO of the Meat Institute, about her career, background, lifelong interest in agriculture and food, and how she joined the Meat Institute following a career in environmental law. The discussion covers the role of the Meat Institute in the food supply chain and how it serves member companies and the food industry in general, through its food safety best practices and a free online course, "The Foundations of Listeria Control." Julia reveals the Protein PACT initiative and explains how food safety relates to risk management with their shared values. She tells how meat processors are good community members. Listen for advice on the culture of safety and how it starts at the very top of the organization.   Key Takeaways: [:01] About RIMS and RIMScast. [:17] About this episode of RIMScast. We will be joined by Julia Anna Potts, the CEO of the Meat Institute. We'll discuss food safety and education, and risk frameworks that the Institute uses to ensure that our food and supply chains are clean. But first… [:47] The next RIMS-CRMP-FED Exam Prep with AFERM will be held on December 3rd and 4th. The next RIMS-CRMP Exam Prep with PARIMA will be held on December 4th and 5th. These are virtual courses. [1:03] Links to these courses can be found through the Certifications page of RIMS.org and through this episode's show notes. [1:11] RIMS Virtual Workshops! On November 19th and 20th, Ken Baker will lead the two-day course, "Applying and Integrating ERM." [1:24] "Managing Data for ERM" will be led again by Pat Saporito. That session will start on December 11th. Registration closes on December 10th. RIMS members always enjoy deep discounts on the virtual workshops. [1:40] The full schedule of virtual workshops can be found on the RIMS.org/education and RIMS.org/education/online-learning pages. A link is also in this episode's notes. [1:52] This episode is released on November 18th, 2025, Day Two of the RIMS ERM Conference in Seattle, Washington. We've covered a lot of ERM ground in the last few episodes. For more ERM, click the link to the RIMS ERM Special Edition of Risk Management magazine in the notes. [2:18] RIMScast ERM coverage is linked as well. Enhance your ERM knowledge with RIMS! [2:24] On with the show! Our guest is Julie Anna Potts. She is the President and CEO of the Meat Institute. She leads the Institute in implementing programs and activities for the association. [2:38] She is an agricultural veteran, previously serving the American Farm Bureau Federation as its Executive Vice President. [2:47] With Thanksgiving coming up next week in the U.S., I thought this would be a great time on RIMScast to talk about food safety, food production, and what another not-for-profit is doing to ensure the safety of our products and the speed and efficiency of our supply chain. [3:07] We're going to have a lot of fun and talk turkey, so let's get to it! [3:12] Interview! Julie Anna Potts, welcome to RIMScast! [3:27] Julie Anna Potts and RIMS CEO, Gary LaBranche, are both part of the Committee of 100 with the U.S. Chamber of Commerce in Washington, D.C. They get together with other association heads across industries. Julie Anna says it is very valuable. [3:44] Julie Anna and Gary were talking in the summer about food safety and about what the Meat Institute does, and Gary invited her to be on RIMScast. [3:57] Justin notes that it is the week before Thanksgiving in the U.S. Juliana says they are doing so much in Washington now, and food safety is always top-of-mind around the holidays. There are lots of turkeys and turkey products being sold in the United States. [4:45] Julie Anna says turkey is cultural for Thanksgiving, and poultry, and how you cook it and handle it in the kitchen is incredibly important for food safety. [5:01] Justin asks, Is fish meat? Julianna says fish is protein, but we don't classify it as meat or poultry. Justin wants to keep the argument going with his family at Thanksgiving. [5:31] Julie Anna says they have lots of arguments around the Meat Institute, like whether ketchup belongs on hot dogs. Julie Anna says the answer to that is no. [5:41] Julie Anna has been at the Meat Institute for a little over seven years. She came in as President and CEO. She has been in Washington for most of her career, since undergrad. She graduated from law school in D.C. and worked at a firm. [5:59] Julie Anna has been in agriculture, representing farmers for years. She went to the Senate as Chief Counsel of the Senate Agriculture Committee. She has been at the Meat Institute for the last seven years. [6:19] Food and agriculture have been central to Julie Anna's career and also to her family life. Her husband grew up on a farm. Julie Anna is two generations off the farm. [6:32] They love to cook, dine out, and eat with their children; all the things you do around the holidays, and gather around the Thanksgiving table. They have passed to one of their three children their love of food traditions. She's their little foodie. [6:52] Julie Anna has a career and a personal life that is centered around food. [7:11] The Meat Institute members are the companies that slaughter animals and do further processing of meat. They are in the supply chain between livestock producers and retail and food service customers. [7:35] To be a general member of the Meat Institute, you have to have a Grant of Inspection from the Food Safety Inspection Service of the USDA. The Federal Grant of Inspection is a requirement to be able to operate and to sell into the market. [7:56] When we look at the capacity we have at the USDA, in the last several months, we're not seeing a decline in capacity, but more emphasis on our Food Safety Inspection Service. [8:18] Through DOGE, voluntary retirements, through additional resources coming in with the One Big Beautiful Bill, and through recruiting, the Meat Institute is seeing its member companies have staffing, even through this government shutdown. They're considered essential, as always.  [8:54] The Meat Institute was established in 1906 for the purpose of addressing food safety and industry issues. Those are Jobs One, Two, and Three, every day. The Meat Institute has all kinds of education it offers to its members. [9:15] The members of the Meat Institute have strong food safety programs. They have HASSA Plans and third-party audits. The Meat Institute helps any member company of any size, from 25 employees to global companies, with education on, for example, Listeria training.   [9:53] The Meat Institute has just launched an online platform that has had great uptake. If you have associates in your business who have never had food safety training, for all levels of folks, there is online, free, and freely available training on how to deal with Listeria. [10:19] All the Meat Institute member companies have significant Food Safety staffing and Food Safety Quality Assurance Programs. Julie Anna praises the people throughout the industry who work in Food Safety for their companies. It's a life-or-death matter. [10:45] Food Safety staff are always seeking to become better, so the Meat Institute has a Food Safety Conference and Advanced Listeria Training (an in-person module). They interface with the regulators, who are partners with the Meat Institute in this.  [11:14] The Meat Institute is always striving for better Best Management Practices across everyone's programs, which are never just the minimum. A philosophy of doing just what is compliant does not get you into the best space. [11:36] The Meat Institute is here to encourage Best in Class, always. Food Safety is non-competitive in the Meat Institute. Everyone across the different-sized companies, from 25 employees to 100,000, can feel comfortable sharing what's working for them. [12:06] That is important when it comes to conferences and other things they do. Let's be candid with each other, because nobody can get better if you're not. [12:17] The Meat Institute has seen cultural issues where CEOs don't think about Food Safety and Quality Assurance because they have great people taking care of it. That's true a lot of the time, until it isn't. [12:42] The tone that needs to be set at the very top of the organization is that this is hugely important for risk management. Hugely important for your brand and your ability to operate. [12:56] The Meat Institute board asked, if we are pushing culture down through the organization, what kinds of questions do I need to ask, not just my Food Safety Team, but everyone, and demonstrating my knowledge, understanding, and commitment to governance of this big risk? [13:31] The Meat Institute created a template of a set of questionnaires for executives. It is a C-Suite document and documentation. [13:47] It's a voluntary questionnaire for a CEO, regardless of company size, indicating that you understand how important this is in ensuring that everything that you push down through your organization, culturally, is focused on Food Safety. [14:05] The link to the Listeria Safety Platform is in this episode's show notes. [14:11] Justin says the structure of the Meat Institute is very similar to the structure of RIMS, with open communications and knowledge-sharing, or else the industry does not grow or improve. [14:27] Justin says it sounds like the industry executives are stepping up their game amid the tumult coming out of Washington. Julie Anna agrees. [14:47] Julie Anna says the Meat Institute has been driving that progress. It is incredibly important. Julie Anna thinks that in a lot of industries, there is a pull and tug between the companies and regulators. [15:07] In the case of meat and poultry inspection and what the Meat Institute does with FSIS, it is a collaboration. The inspectors verify for consumers what the companies are doing to keep food safe. [15:28] It is up to the company to decide how it is going to do this effectively and successfully and get better at it. [15:41] Numerous third parties do audits and help customers across the supply chain, but the responsibility rests with the companies. [15:59] The Meat Institute staff has highly technical people who come out of academia, out of the plant, having done FSQA, Legal, and safety regulations. There are folks who have been in inspection in the government at FSIS. [16:29] The Meat Institute has several staff whose job it is to stay on top of the latest improvements and ensure that everybody knows what those are, and in dialogue with our FSIS inspection leadership here in Washington, D.C. [16:46] The Meat Institute looks to FSIS to make sure that consumer confidence is there. It does nothing for our industry if consumers think that FSIS isn't being an effective regulator. [17:11] The Meat Institute companies have to be the ones that do more than the bare minimum to ensure they're doing the best they can. The Meat Institute's philosophy is always to push further and further. [17:25] There is an expense associated with that. The Meat Institute does its best to help manage that risk for its companies by giving them everything they need to be the best that they can be. [17:40] The Meat Institute has 36 employees. They are very transparent in the Food Safety world. They want non-members to take advantage of all their resources in Food Safety. A lot of the things they offer on education and regulations can be accessed without being a member. [18:14] The Meat Institute has recently joined an alliance to stop food-borne illness and is looking to get more engaged in that organization. That's across several segments, not just meat and poultry. [18:35] The Meat Institute has committed and re-committed over the years to the efforts it makes with its companies. The Meat Institute looks for its companies to be leaders in the Food Safety space. [18:53] Quick Break! The RIMS CRO Certificate Program in Advanced Enterprise Risk Management is our live virtual program led by the famous James Lam. Great news! A third cohort has been announced, from January through March 2026! [19:14] Registration closes January 5th. Enroll now. A link is in this episode's show notes. [19:22] Save the dates March 18th and 19th, 2026, for The RIMS Legislative Summit, which will be held in Washington, D.C. [19:31] Join us in Washington, D.C., for two days of Congressional Meetings, networking, and advocating on behalf of the risk management community. Visit RIMS.org/Advocacy for more information and updates and to register. [19:45] We've got more plugs later. Let's return to our interview with Meat Institute CEO Julie Anna Potts! [19:56] Julie Anna says a lot of our companies are also regulated by the FDA because they do further processing. For example, pizzas with pepperoni, or any number of mixed products that have both FDA and USDA regulatory personnel on site. [20:20] FSIS is, by far, more present and more in tune with what member companies are doing than the inspectors at the FDA. [20:30] Justin asks if restaurants can be members of the Meat Institute. There is a segment of membership called Allied Members, which includes restaurants and grocery stores. If they are not processors, but they are procuring meat and poultry for sale, they are in the meat industry. [21:09] The Meat Institute has had a great deal of interaction on many issues with its retail and food service customers. [21:25] Shortly after she joined the Meat Institute, Julie Anna was handed a mandate from the board to be proactive and lean in on the things consumers are interested in with an initiative to continue to maintain or rebuild trust. [21:48] These are things like food safety, animal welfare, environmental impact, and worker safety. They call this initiative Protein PACT (People, Animals, and the Climate of Tomorrow). Food Safety is front and center in Protein PACT. [22:13] The Meat Institute has a way of focusing its efforts through this lens of improvement in five areas that work together to reassure consumers. When they know that you're working on all these issues and trying to improve, it increases trust in all the above issues. [22:54] Retail and Food Service customers in the industry want to know more and more. They want to know upstream, what are you doing to get better? [23:05] They want to know how they can take the data that you are collecting anonymously and in the aggregate to communicate at the point-of-sale area to ensure that their customers, collectively, are getting what they need? [23:23] Julie Anna saw this recently at H-E-B, a popular grocer in Texas. Julie Anna walked through one of their huge, beautiful, newly renovated stores. The engagement the ultimate customer has is in the store, asking questions of the butcher. [24:07] It's wonderful to be able to say, If you have food safety concerns, we have a relationship that we can give you the knowledge you need to answer those concerns, and it's coming very consistently across the industry. [24:40] Justin asks, When the Meat Institute members lean in, are they leaning in at 85% or 93%? You'll only get ground beef jokes here, on RIMScast! Julie Anna says, it's all good. Justin says those kinds of jokes are called The Manager's Special. [25:17] One Final Break! RISKWORLD 2026 will be held from May 3rd through the 6th in Philadelphia, Pennsylvania. RISKWORLD attracts more than 10,000 risk professionals from across the globe. Guess what! Booth sales are open now! [25:37] This is the chance to showcase your solutions, meet decision-makers face-to-face, and expand your global network. Connect, Cultivate, and Collaborate with us at the largest risk management event of the year. The link to booth sales is in this episode's show notes. [25:53] Let's Return to the Conclusion of My Interview with Meat Institute CEO Julie Anna Potts! [26:16] Julie Anna was an environmental lawyer in private practice. Her work involved the Clean Water Act, the Clean Air Act, the National Environmental Policy Act, and Superfund. One of her clients was the American Farm Bureau Federation (AFBF). [26:42] When Julie Anna left the firm, she moved in as General Counsel to the AFBF, the largest general farm organization in the U.S. Besides environmental law, she worked there in lots of other types of law as General Counsel. [27:06] At the Meat Institute, Julie Anna collaborates with the AFBF. The ag sector in Washington, D.C., is very collaborative. The Meat Institute works closely with the National Cattlemen's Beef Association, the National Pork Producers Council, and the commodity groups. [27:35] Everybody is connected. If you are working on an animal issue, you're going into crop groups and animal health companies. The Meat Institute works with everyone. Their philosophy is, We all get better when we share knowledge. [28:03] That's the basis of the conversation Julie Anna and Gary LaBranche had in the summer about this podcast. The Meat Institute has resources it would love to share on the risk management of food safety issues. [28:20] The Meat Institute also knows consultants and other help outside of the meat industry that they can point people to, as needed. The Meat Institute would love to be a resource to the listeners of RIMScast. You can check out the contact information in the show notes. [29:02] Julie Anna is familiar with risk professionals. She serves on the board of Nationwide Insurance. Nationwide Agribusiness has Food Safety expertise. When Julie Anna practiced law, she worked with clients on helping them manage risk and assess potential outcomes. [30:09] Julie Anna says risk management is one of her favorite topics. How do you plan to recover from a flood after a hurricane? How do you plan for farm animal disease? There are now three animal disease outbreaks that are constantly on their minds at the Meat Institute. [30:31] The Meat Institute helps run tabletop exercises with its companies, sometimes involving government officials, as well. It's New World Screwworm to the South. It's High Path Avian Influenza, which has crossed over from poultry to dairy and beef cattle.  [30:48] Julie Anna continues, We have African Swine Fever, which has not gotten to the United States, thank goodness! All of these require a certain level of preparedness. So we work on it as a policy matter, but we also need to operationalize what happens when this happens. [31:16] The pandemic is a good recent example of what happens when things fall apart. Member companies have a very limited ability to hold live animals if they're not going to slaughter. They don't have anywhere to go. [31:44] The pandemic was an example of what happens when something reduces capacity and the animals start backing up. It's incredibly important that things work. The pandemic was unimaginable to a lot of people. It tested our risk management models. [32:10] Once we were there, dealing with it, we had incredible adaptability to the circumstances we were facing. That only happens if you face certain problems every day to keep that plant running. For member companies, if the plants don't run, the animals don't have a place to go. [32:37] Farmers get a lower price for their animals, consumers have the perception that there's not going to be enough food, and there's a run on the grocery stores. During the pandemic, it righted itself really quickly, once we got some PPE, etc. in place, and some guidance. [32:59] The member companies relied heavily on the CDC to tell them how to get people in so the plants could run. It was difficult for everyone. Julie Anna thinks that we learned a lot from that experience on how to help your company troubleshoot in the moment to keep going. [33:37] Julie Anna addresses how PFAS issues are being handled. It's an EPA issue and a state's issue for regulations on packaging and recycling. The state issues are predominant. Environmental issues are being addressed at the state level. We could end with 50 regimes. [35:04] That's where there's more risk for the Meat Institute and its members, especially companies that sell nationwide. There is very little state regulatory work that the Meat Institute does directly. [35:26] The Meat Institute is examining how to utilize other resources to figure out, with a small staff, how to monitor and stay ahead of these things for our members. That's very much on their minds. The EPA's work has been swinging back and forth between administrations. [36:02] It's hard to convince a business of a good recommendation if the rules are going to change with the next administration. It's a problem of where to invest in things like measuring emissions and what to do to satisfy customers when the rhetoric changes dramatically. [37:04] Justin says we've had a different administration every four years for the last 16 years. He says if he were a business owner, he would do everything he could to make sure the water coming in and going out is clean to avoid verdicts. Nuclear verdicts are through the roof. [37:27] Julie Anna speaks of social inflation by juries wishing to send a message to big corporate entities. She says member companies are dealing with these issues all the time. What's the right amount of rulemaking for effluent limitation guidelines? [38:20] The Meat Institute had opposed what the Biden administration had proposed, given that the number of companies it estimated would not be able to stay in business was close to 80. The Trump administration has backed off and is leaving in place what was there before. [38:52] That's all part of the Federal policy debate in D.C. It does not diminish the commitment its members have to be good community members. They work in their communities. Julie Anna was just down in East Tennessee at a wonderful family company, Swaggerty Sausage. [39:16] They do water treatment. They are beloved in the community because of how they take care of people. They bring in pigs from North Carolina and turn them into sausage. Julie Anna met the fifth generation. He is eight months old. [39:40] Julie Anna had a great visit with people, understanding how their commitment to the environment and animal welfare, and the things they can show their community members that they are doing, works for them. Julie Anna saw how the sausage is made, Justin adds. [40:28] Justin says, You've been such a delight to speak with, and we've learned so much. Is this the busiest time of year for your members, with Thanksgiving coming up, the religious holidays coming up, and then New Year's? Are they keeping Safety at the top of their risk radar now? [40:59] Julie Anna says Our members, and we, keep Safety at the top of the risk radar every single day. It does not get harder during high-volume days. [41:15] There's a spike around Memorial Day, Fourth of July, and Labor Day. There's a lot more turkey happening around Thanksgiving and possibly Christmas, but certainly, hot dogs, hamburgers, sausages, brisket, and all kinds of things. It's cyclical. [41:49] Julie Anna wishes Justin could come into a plant with her, walk through, and see the number of times there are interventions for food safety. X-rays for foreign material. Sprays for certain types of pathogens, and the ways in which the hide is treated. [42:14] It is such a huge part, and they are so proud of what they do. They are happy to show anybody how we continue to hold that up as the most important thing. Worker Safety is also hugely important. We're talking about our humans and what we do to protect them. [42:42] Safety is really important, and it does not receive any less attention at busy times. [42:50] Justin says that's a great sentiment to close on. It has been such a delight to speak with you, and I'm so glad we had the chance to do this. It's going to be especially impactful now, just ahead of Thanksgiving and the religious holidays, and the New Year. [43:16] Special thanks to Julie Anna Potts of the Meat Institute for joining us here on RIMScast just ahead of Thanksgiving 2025. Links to the Meat Institute resources are in this episode's show notes, as is RIMS coverage of Food Safety and related topics. [43:34] Plug Time! You can sponsor a RIMScast episode for this, our weekly show, or a dedicated episode. Links to sponsored episodes are in the show notes. [44:02] RIMScast has a global audience of risk and insurance professionals, legal professionals, students, business leaders, C-Suite executives, and more. Let's collaborate and help you reach them! Contact pd@rims.org for more information. [44:20] Become a RIMS member and get access to the tools, thought leadership, and network you need to succeed. Visit RIMS.org/membership or email membershipdept@RIMS.org for more information. [44:38] Risk Knowledge is the RIMS searchable content library that provides relevant information for today's risk professionals. Materials include RIMS executive reports, survey findings, contributed articles, industry research, benchmarking data, and more. [44:54] For the best reporting on the profession of risk management, read Risk Management Magazine at RMMagazine.com. It is written and published by the best minds in risk management. [45:09] Justin Smulison is the Business Content Manager at RIMS. Please remember to subscribe to RIMScast on your favorite podcasting app. You can email us at Content@RIMS.org. [45:21] Practice good risk management, stay safe, and thank you again for your continuous support!   Links: RIMS-CRO Certificate Program In Advanced Enterprise Risk Management | Jan‒March 2026 Cohort | Led by James Lam RISK PAC | RIMS Advocacy | RIMS Legislative Summit SAVE THE DATE — March 18‒19, 2026 RIMS-Certified Risk Management Professional (RIMS-CRMP) Reserve your booth at RISKWORLD 2026! The Strategic and Enterprise Risk Center RIMS Diversity Equity Inclusion Council RIMS Risk Management magazine | Contribute RIMS Risk Management Magazine: "USDA Budget Cuts Present Food Safety Risks" (May 2025) Meat Institute Meat Institute — Foundations of Listeria Control RIMS Risk Management magazine ERM Special Edition 2025 RIMS Now Upcoming RIMS Webinars: RIMS.org/Webinars   Upcoming RIMS-CRMP Prep Virtual Workshops: RIMS-CRMP-FED Exam Prep with AFERM Virtual Workshop — December 3‒4 RIMS-CRMP Exam Prep with PARIMA — December 4‒5, 2025 Full RIMS-CRMP Prep Course Schedule "Applying and Integrating ERM" | Nov 19‒20, 2025 | April 4, 2026 "Leveraging Data and Analytics for Continuous Risk Management (Part I)" | Dec 4. See the full calendar of RIMS Virtual Workshops RIMS-CRMP Prep Workshops   Related RIMScast Episodes: "Recipes for Success with Wendy's CRO Bob Bowman" "Franchise Risks with Karen Agostinho of Five Guys Enterprises" "Risk Insight with AAIN Leadership and Panda Express"   Sponsored RIMScast Episodes: Secondary Perils, Major Risks: The New Face of Weather-Related Challenges | Sponsored by AXA XL (New!) 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RIMS Virtual Workshops On-Demand Webinars RIMS-Certified Risk Management Professional (RIMS-CRMP) RISK PAC | RIMS Advocacy RIMS Strategic & Enterprise Risk Center RIMS-CRMP Stories — Featuring RIMS President Kristen Peed!   RIMS Events, Education, and Services: RIMS Risk Maturity Model®   Sponsor RIMScast: Contact sales@rims.org or pd@rims.org for more information.   Want to Learn More? Keep up with the podcast on RIMS.org, and listen on Spotify and Apple Podcasts.   Have a question or suggestion? Email: Content@rims.org.   Join the Conversation! Follow @RIMSorg on Facebook, Twitter, and LinkedIn.   About our guest: Julie Anna Potts, CEO, The Meat Institute   Production and engineering provided by Podfly.  

The FDA Group's Nick Capman sits down with Maria Vassileva, PhD—Chief Science & Regulatory Officer at the Drug Information Association (DIA)—for a grounded, forward-looking discussion on how regulators are actually using AI today, where the technology is going, and what life science organizations should be preparing for now.Maria draws on two decades of leadership across nonprofit, government-funded clinical research, and biomedical science programs—spanning patient registries, clinical trials, multi-stakeholder consortia, DEI initiatives, and regulatory strategy. As the head of DIA's global science and regulatory portfolio, she works closely with regulators, industry sponsors, academia, and technology developers to advance responsible, evidence-driven innovation.In this conversation, Maria breaks down the reality behind AI in the regulatory ecosystem: what's currently in use, how agencies are evaluating and validating tools, why risk-based tiers matter, and how the field is moving toward lifecycle oversight rather than one-time checks. She also highlights the ethical and equity considerations that must be embedded from the start and shares insights from global regulatory trends and DIA's convening role.Key topics discussed include:How regulatory agencies are already using AI internally for document-heavy workflows, safety surveillance, and information retrievalWhy validation must focus on end-to-end workflow integrity, not just the modelThe emerging role of risk-based tiers for AI-enabled toolsThe importance of lifecycle control frameworks such as TPLC and PCCPsGlobal convergence themes around transparency, bias mitigation, and human accountabilityHow agencies are preparing for increasing AI adoption—and what industry teams should be doing nowDIA's role as a neutral convener helping harmonize expectations and accelerate responsible innovationAbout The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

As AI promises to accelerate drug development, a critical question emerges: can pharmaceutical manufacturing keep pace? In this episode, Martin Wood and Adrian La Porta examine how artificial intelligence could transform the entire pharmaceutical value chain, from quality control paradigms to facility design.Recorded as a preview to Bryden Wood's Accelerate Pharmaceuticals event on 25th November, the discussion explores fundamental questions about the future of drug manufacturing. Adrian argues that current quality systems are essentially compensations for our limited understanding of manufacturing processes - and that AI could enable a complete reversal of this paradigm through real-time, data-driven quality monitoring.The conversation ranges from the potential for patient data feedback loops that could reshape manufacturing in near real-time, to whether facilities should be designed around autonomous systems rather than people. They examine why continuous manufacturing has struggled to gain traction, whether digital twins could eliminate traditional scale-up challenges, and how distributed manufacturing models might reshape global supply chains.A thought-provoking exploration of whether AI can finally bridge the longstanding gap between drug development innovation and manufacturing industrialisation - and what it will take to get there.Send us a textTo learn more about Bryden Wood's Design to Value philosophy, visit www.brydenwood.com. You can also follow Bryden Wood on LinkedIn.

In this super-informative episode, top industry trainer and thought leader, Trey Briggs, breaks down how digitally automated QA was developed, how it works, and how companies routinely tell call center executives it includes AI technology when they know it does not. Trey offers industry-leading solutions based on a unique level of knowledge and expertise. Check it out!

If you're a leader in game dev who feels stuck, there is a path forward that levels up your leadership and accelerates your team, game, and career. Sign up here to learn more: https://forms.gle/nqRTUvgFrtdYuCbr6 You can't just test quality into a game at the end. You have to build it in from the start. Ignoring your Quality Assurance team's full value is a fast way to lose millions. The state of game development is at a challenging inflection point, characterized by high-risk live service ambitions and a brain drain of senior talent. Host Ben Carcich sits down with Nathan Tiras, former Game Dev veteran (Riot Games, Singularity 6), to dissect this instability and dive deep into the discipline seen as an "entry-level" role: Quality Assurance (QA). Nathan, who worked his way from a QA Analyst at Riot to the Director of QA and Live Service at Singularity 6 (makers of Palia), argues that QA is not just "testing" but a critical quality function that represents the voice of the player. This deep-dive explores how leaders must move beyond the "QA as tester" stereotype to unlock the massive subjective value and risk-prevention only highly skilled, respected QA professionals can provide. What You'll Learn in this Episode: What "quality" really means in 2025, and why the best QA teams shape player experience How bringing QA in at pre-production saves time, money, and your launch day sanity Why bug counts don't define QA's worth The human edge of judgment, creativity, and tribal knowledge that no tool can replicate How great leaders build quality teams that protect business continuity and deliver real returns Learn more about Nathan: LinkedIn: https://www.linkedin.com/in/nathan-tiras-he-him-8a45754/ Company: https://www.whatnot.com/ Instagram: https://www.instagram.com/nathantiras/?hl=en Board Game Geek: https://boardgamegeek.com/boardgamedesigner/95100/nathan-tiras Check his other YouTube appearances: https://www.youtube.com/watch?v=E2mmERgh19c https://www.youtube.com/watch?v=Xyt3bnBgNqk Connect with us:

In this episode we spoke with Damien Wong, Senior Vice President for Asia Pacific at Tricentis, about how Agentic AI is redefining software quality assurance (QA) for enterprises navigating digital transformation. Damien shared his journey through 30 years in enterprise technology and explained how Tricentis is pioneering a future where autonomous testing drives both speed and reliability in software delivery. We explored why QA is fast becoming a board-level priority, how AI is removing the human bottlenecks in testing, and why quality is now existential in sectors like finance, healthcare, and government. Key Insights: • From manual to agentic: QA has evolved from manual testing to script-based automation, to codeless model-based testing, and now to agentic test automation. The equivalent of moving from driving a car to a fully autonomous vehicle. • AI-accelerated quality: Tricentis' agentic automation enables systems to autonomously create, execute, and adapt tests, dramatically accelerating release cycles and reducing risk from untested code. • Quality as a board concern: In Tricentis' Quality Transformation Report, two-thirds of organizations admitted to shipping untested code, making QA failures a C-suite and reputational risk rather than an IT issue. • Compliance through transparency: With acquisitions like SeaLights, Tricentis helps enterprises prove that every code change has been tested—critical for regulated sectors and global compliance. • Bring-your-own-AI flexibility: Tricentis' support for the Model Context Protocol (MCP) allows companies to plug in their own private AI models, ensuring data security and regulatory control while leveraging AI capabilities. • Empowering, not replacing, engineers: AI-driven testing shifts QA teams from repetitive test creation to strategic oversight, while tools like NeoLoad with natural language prompts make performance testing accessible to non-technical users. • Industry impact: From Zespri's self-healing ERP testing to preventing outages like Haribo's global gummy bear disruption, intelligent QA ensures business continuity and customer trust. • Future outlook: With 90% of code expected to be AI-generated within a year, the ability to test at AI speed will define competitive advantage in enterprise software delivery. IoT ONE case study database: https://www.iotone.com/case-studies The Industrial IoT Spotlight podcast is produced by Asia Growth Partners (AGP): https://asiagrowthpartners.com

In this special in person episode of The Behavioral View, hosts Dr. Shannon Hill and Dr. Nissa Van Etten broadcast from the CR Unite 2025 Conference in Chicago to discuss the latest innovations shaping behavior analysis. They're joined by Amber Ledesma, BCBA and Customer Success Lead III at CentralReach, and Dr. Alana Fallucca, Director of Quality Assurance at Above and Beyond Therapy, for an unscripted, in-person conversation about the evolution of assessments, outcomes tracking, and AI in clinical practice.  While there is no CEU associated with this episode at this time if you wish to watch the episode and earn 30 minutes Staff Training certificate.  Please click here.

Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly. In this episode, we break down what RWE really means, how it differs between the FDA and the EU MDR, and how you can design a compliant, global strategy that turns data into regulatory strength. You'll learn: What qualifies as Real-World Data (RWD) and Real-World Evidence (RWE) How the FDA integrates RWE into premarket submissions (510(k), De Novo, PMA) How EU MDR uses RWE through PMCF and PMS The key differences in approach between the two regions A practical 5-step roadmap to build a compliant RWE strategy Common pitfalls (bias, poor traceability, privacy issues) — and how to avoid them

Send us a textToday we're discussing a topic that's bringing well-deserved recognition—and financial support—to the educators who are the backbone of our child care system: the Quality Rated Workforce Bonuses. Funded by DECAL, this annual $500 bonus is a way to say “thank you” to the teachers and staff who go above and beyond in serving children and families. Joining us with an update on the Quality Rated Workforce Bonuses is Rachel Lee, Assistant Director of Quality Assurance and Business Operations for Quality Innovations and Partnerships. Support the show

On this episode of Beyond the Horizon, we sit down with Senior Master Sgt. Derek Sams, the installation superintendent of the 220th Engineering Installation Squadron, and Tech. Sgt Zachary grant, the Quality Assurance representative for the 220th EIS, to discuss why it's important to strive to meet you full potential as one of the Ohio Adjutant General's 19 Fundamentals for the Soldiers and Airmen of the Ohio National Guard.You can connect with us on: Facebook: http://www.facebook.com/178WingInstagram: http://instagram.com/178th_wingYou can write to us at: beyondthehorizonpodcast@gmail.com

In this episode, Shiv is in conversation with Naresh Choudhary, Senior Vice President, Quality & Productivity, Infosys Ltd.Naresh shares his career journey starting from humble beginnings in Mumbai, studying engineering at VJTI, working at Arvind Mills, and eventually contributing to Infosys for 25 years. The discussion covers his transition from manufacturing to IT, the influence of mentors, various roles at Infosys, and the importance of reframing roles. Naresh also emphasizes the value of great work, networking, mentorship, and maintaining a work-life balance. He talks about driving innovation and change management effectively within a large organization through transparent communication, planning, and continuous feedback. Finally, Naresh offers personal practices like journaling, exercising, and separating work from family time to stay grounded and calm.00:00 Welcome and Introduction00:23 Early Career and Education02:00 Transition to Infosys03:43 Roles and Responsibilities at Infosys07:16 Mentorship and Career Growth10:28 Defining Great Work15:32 Overcoming Self-Doubt and Imposter Syndrome19:28 The Importance of Mentors24:23 Networking and Time Management29:19 Clearing the Mind for Focus29:51 Work-Life Balance and Breaks30:59 Organizational Change and Trust33:51 Planning and Transparency in Change34:51 Process Over Tools36:04 Sponsorship and Milestone Reviews37:46 Encouraging Knowledge Sharing43:58 Innovation and Idea Management47:33 Staying Grounded Amidst Responsibilities53:00 Personal Practices for Balance56:48 Conclusion and Final ThoughtsBio:In his stint at Infosys over 2 decades, Naresh has worked in different roles in Software Delivery, Consulting, Quality Assurance, Open Source, Enterprise Platforms, Products, Tools & Technology that have provided him opportunities to work on key transformation programs.Naresh has experience in Software Development, Quality System Design, Process definition, Implementation and Consulting, Product & Platform Engineering, Software Reuse, Knowledge Management, Training, Audits and Assessments. He possesses a sound understanding of various quality models, methodologies and frameworks like CMMI, ISO, Six Sigma, MBNQA, AI, Automation,  Agile, DevSecOps & SRE.Naresh participates on several product councils and advisory boards with Infosys' global technology partners and is currently leading the effort on reimagining the tooling, engineering excellence, digital platforms, Lean and automation landscape for the enterpriseHe is a self confessed Foodie, History enthusiast, Amateur Chef, Motivational Speakerhttps://www.linkedin.com/in/nareshchoudhary/

Kieron Allen speaks with Chris Pope, Chief Product Officer at AutomatePro, in an in-depth discussion that is part of a broader series of podcasts, articles, and reports on ServiceNow's evolving ecosystem. They explore how intelligent automation and agentic AI are reshaping DevOps and quality assurance. The conversation also highlights how AutomatePro's built-on approach enhances developer productivity, reduces risk, and ensures security, all within the ServiceNow environment.AutomatePro's AI EdgeThe Big ThemesAutomatePro's Core Mission: AutomatePro focuses on solving one of the most time-consuming parts of software delivery: testing and documentation. Pope explains that their goal isn't to replace humans but to augment their efforts through intelligent automation. By embedding deeply within the ServiceNow platform, AutomatePro allows developers and platform owners to automate repetitive tasks early in the development cycle, ensuring higher-quality releases and faster deployment.Human-AI Collaboration Wins: The myth of AI replacing people is outdated. Pope reframes the conversation: it's not about replacement, it's about enablement. The real winners will be those who know how to use AI effectively. Today's Copilots are context-aware, learning from human behavior and adapting to different personas — whether it's a developer, analyst, or HR owner. Prompt engineering is emerging as a vital skill, and the better the prompt, the better the AI-driven output.DevOps Innovation Without Compromise: AutomatePro and ServiceNow are reshaping DevOps by making speed and quality compatible. Historically, faster releases meant riskier ones. With AutomatePro's intelligent testing automation, that tradeoff no longer exists. Frequent, smaller releases — the “fixed forward” model — are now safer thanks to early automation, embedded security, and contextual AI. Pope argues that platform owners and developers are the new heroes in enterprise IT, and equipping them with Copilots, intelligent workflows, and instant feedback loops unlocks untapped value.The Big Quote: "You're not going to be replaced by AI per se, you're going to be replaced by someone that knows how to use AI effectively."More from ServiceNow and AutomatePro:Follow AutomatePro on LinkedIn or learn more about ServiceNow and intelligent automation. Visit Cloud Wars for more.

Coruna Medical's Vice President of Quality, Jeff Hines, joins host Nick Capman to share a leadership-driven playbook for navigating FDA remediation—without overwhelming teams or losing focus on long-term improvement.Drawing from nearly four decades in pharmaceutical quality, including more than 30 years at Eli Lilly, Jeff offers practical guidance for building calm, effective inspection environments and keeping people confident under pressure. He outlines the four-room model for inspection management, strategies for responding to observations, and proven methods for closing data-integrity gaps while daily operations continue.Jeff and Nick also explore the leadership mindset that sustains progress beyond the initial response—fostering transparency, prioritization, and a culture of accountability that prevents repeat findings.Topics discussed include:The leadership posture that steadies teams during inspections and remediationHow to stand up the four-room inspection model (Front, Back, Doc-QC, SME-Prep)Responding to 483s: when to push, when to accept, and how to align internallyData-integrity vulnerabilities and effective interim controlsBalancing remediation with production demandsBuilding transparency and accountability into quality cultureKeeping systems current to avoid backsliding into repeat observationsAbout The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: ⁠https://www.thefdagroup.com/

Talked with Dr. Karen GIlbert, Vice President of Education and Quality Assurance for Alzheimer's Community Care in West Palm Beach, Florida.  She and Blake Davis will present how behaviors become a form of communication with folks living with dementia-related illnesses especially as the disease progresses at the upcoming Alzheimer's Foundation of America event.  "The Alzheimer's Foundation of America (AFA) will host a free Alzheimer's & Caregiving Educational Conference for South Florida residents on Wednesday, November 19 from 10:00 am to 1:00 pm ET at the Boca Raton Marriott at Boca Center (5150 Town Center Circle, Boca Raton). The free conference is open to everyone and will allow participants to learn from experts in the field of Alzheimer's disease, brain health, and caregiving. Register by visiting www.alzfdn.org/tour. Advance registration is highly recommended."  Listeners can also get info about local adult day services and the free lost on foot program at www.alzcare.org.

Yeast is the critical ingredient that turns humble wort into magical beer. This month, a look at the microbe from multiple angles and how to make the most out of it in your small-scale craft brewery.Guests: Laura Burns, Ph.D. is the Director of Research and Development at Omega Yeast. After studying stress responses in Saccharomyces cerevisiae for her graduate thesis at Vanderbilt University, she decided the best place to apply this knowledge was in brewing. She worked in production brewing for five years as Head Brewer and Director of Quality Assurance before heading back to the bench at Omega Yeast. Her undeniable curiosity drives her to tackle difficult questions that brewer's face daily. Technical Sales Manager for the home segment at Fermentis, Hugo Picard is in charge to support homebrewers, winemakers, cidermakers, in their hobby for beverage production at home. Hugo graduated with a Master's in Science and Agricultural Engineering from ISA Lille in France. He also acquired a Master's degree in International Marketing and Communication at Lille University. Before joining Fermentis, he has been president of a brewing and winemaking association and worked in several breweries and brewpubs in France and New-Zealand as a brewer or as a marketing/communication associate.The BYO Nano Podcast Episode 70  is sponsored by:BYO NanoCon on October 24Next week on Friday, October 24, learn from craft brewing industry experts with live online sessions covering Brewery Operations, Business Operations & Sales, and Start-Ups.• Full-Day of Live, Online Seminars and Q&A Panels• Access to Video Recordings and Course Materials for All Sessions• 3 Learning Tracks: Business & Sales, Brewing Operations, Start-Ups• Get Your Questions Answered Live by Craft Beer Experts• Interact with Other Small-Scale Craft Brewers & Breweries-In-Planning• Q&A Sessions with Leading Small-Scale Brewing Suppliers Check out https://byo.com/product/2025-nanocon-online/ for more details.BYO Nano+ MembershipGet access to hundreds of hours of on-demand videos covering small craft brewery strategies with BYO's Nano+ Membership. Learn from craft beer experts watching replays of past NanoCon seminars plus a complete library of in-depth workshops. You'll also have full online access to all of BYO's digital content and an annual digital magazine subscription. Check out byo.com/nanoplus for more details.BYO Nano Brew Podcast Episode 70Host: John HollGuests: Laura Burns, Hugo PicardContact: nano@byo.comMusic: Scott McCampbellPhoto: by John Holl

The FDA Group's Nick Capman speaks with Marwan Fathallah, President and CEO of DIA Global, for a wide-ranging discussion on what it takes to lead effectively across the life science product development cycle—from concept to commercialization.With nearly 30 years of leadership experience spanning pharmaceuticals, medical devices, and diagnostics, Marwan has held senior roles in R&D, regulatory, clinical, scientific affairs, and operations. He brings a rare, holistic view of how leadership, culture, and systems thinking come together to drive successful outcomes in complex, regulated environments.Their conversation explores how to balance innovation and compliance, structure cross-functional teams for consistent execution, and foster cultures that prioritize transparency, collaboration, and patient focus.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

The FDA Group's Nick Capman speaks with Regina Atim, PharmD, pharmacist, maternal and perinatal health advocate, and founder of Clinicians Touch Healthcare Solutions. Regina brings deep expertise at the intersection of clinical practice, regulatory strategy, and maternal health innovation—including work on technologies to detect pregnancy-acquired cardiovascular disease.Their conversation explores FDA/ICH's new E21 draft guidance, Inclusion of Pregnant and Breastfeeding Women in Clinical Trials. Regina explains why pregnant and breastfeeding women have historically been excluded from research, how that has left clinicians and patients with insufficient evidence, and why E21 represents a cultural and scientific shift toward safe, risk-based inclusion.Read the draft guidance here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e21-inclusion-pregnant-and-breastfeeding-women-clinical-trialsRegina shares practical insights on:How physiologic changes in pregnancy alter drug absorption, distribution, metabolism, and elimination.The dangers of underdosing, overdosing, or avoiding treatment altogether in the absence of trial data.Why clinicians should avoid inappropriate substitutions (e.g., some NSAIDs) and instead rely on evidence-based dosing.How E21 encourages continued monitoring of participants who become pregnant during a trial rather than automatic withdrawal.The stepwise approach to lactation studies—starting with breast milk concentration, then estimating infant dose, and eventually assessing infant exposure and safety.The role of PK/PD modeling, nonclinical data, and real-world evidence in bridging evidence gaps.How sponsors can engage FDA early to align on inclusion triggers and maternal–fetal expertise.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

Healing from the Heart. In this episode of Your Next Mission® video podcast, SMA Tilley welcomes Claire Lawless, Former Senior Director, Quality Assurance & Brandi Salvatore, Case Manager, The Steven A. Cohen Military Family Clinic at Alaska Behavioral Health at Cohen Veterans Network. They highlight Cohen Veterans Network's mission to provide accessible, barrier free, high-quality mental health care for Veterans and their families.

The FDA Group's Nick Capman speaks with Catherine Lunardi, Founder and CEO of GenAIz. With nearly a decade leading GenAIz and prior leadership roles at GSK, CGI, and Héma-Québec, Catherine brings a seasoned perspective on how life science organizations can practically and compliantly deploy AI to build the next generation of labs.Catherine explains the biggest challenges labs face today—like fragmented data, manual processes, and costly compliance reviews—and how AI can help orchestrate data, surface anomalies, and accelerate insights without replacing the people at the center of science. She outlines a step-by-step approach to identifying the right challenges, aligning AI projects with company strategy, piloting solutions with clear ROI, and managing change so teams embrace and sustain new tools.Nick and Catherine also discuss the balance between innovation and regulation, how to keep humans in the loop, and why strong governance and explainability are essential to ensuring AI adds real value in GLP environments.About The FDA Group: The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: ⁠https://www.thefdagroup.com/

The FDA Group's Nick Capman speaks with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals. With more than 25 years of pharmaceutical manufacturing experience spanning branded, generic, and OTC products, Jeff brings a deep perspective on sustaining inspection readiness across multiple sites while leading global quality teams.Jeff shares why inspections feel less predictable today—with more variability in inspector experience and a higher likelihood that minor issues become formal observations—and how leaders can respond without overreacting. He explains how to prepare documentation so that it's understandable to any inspector, what makes a quality system truly “robust” in practice, and why culture, accountability, and simplicity matter as much as compliance.Nick and Jeff also explore practical steps for keeping data integrity controls sharp, building efficient systems that don't overburden teams, and fostering engagement so quality is seen as a partner, not just a policing function.About The FDA Group: The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

“If you're a professional and the rules of your profession change, you can't afford not to keep up.”  — Scott Doyle   In this episode of the RESTalk podcast, host Bill Spohn sits down with two long-time leaders at RESNET

In this episode of Fresh Perspectives in Social Work, Lisa Roberts, Manager in BerryDunn's State Government Practice Group sits down with Cammie Chapman, Special Counsel with Brown & Peisch and the former Deputy Secretary of West Virginia's Department of Human Services, to explore how developing and implementing a robust quality assurance program can support the legal defense in class action lawsuits involving the American with Disabilities Act (ADA). You'll hear insights on the importance of quality assurance overall, as well as a deeper dive into how states can use a continuous quality improvement process to positively benefit the children, youth, and families they serve. Whether you're a social worker, state government leader, or compliance officer, this episode offers practical tips that will benefit your staff and the communities you serve.

The FDA Group's Nick Capman speaks with Marcus Gesner, Vice President of Global Quality at embecta. With more than two decades of leadership experience at companies including Boston Scientific, Olympus, Covidien, JUUL Labs, and others, Marcus brings a unique perspective to what makes a quality organization truly high-performing.Marcus shares why compliance is only the baseline “entry fee” for quality—and how high-functioning teams go further by protecting a company's right to compete, preventing manufacturing and supply disruptions, enabling speed to market, and building trust across the business.He discusses the metrics that matter most (like defect rates, back orders, holds, complaints, and R&D delays), how to structure incentives that drive the right behaviors, and practical strategies for recruiting, onboarding, and retaining people with the drive, courage, and creativity to lead meaningful change.Nick and Marcus also explore how leaders can create the right balance of accountability and innovation, foster collaboration across functions, and ensure quality is seen as a value-driving partner rather than a cost center or policing function.About The FDA Group:The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

Behind the scenes at Disney, it's leadership that truly runs the show. In this episode, Lee Cockerell shares the surprising leadership secrets that helped him oversee 40,000 cast members as the former VP of Operations for Walt Disney World Resort. From his time at Hilton, Marriott, and Disney, he breaks down the habits and leadership principles that helped him become one of the industry's most respected leaders. You'll learn what it takes to be successful in any role, why routines matter more than you think, and how to become the kind of leader people want to work with. Topics discussed: How Lee built his career with no college degree What he learned working at Hilton and Marriott Why some leaders fail How his leadership style has evolved The habits and mindset that made him successful The legacy of his book, Creating Magic: 10 Common Sense Leadership Strategies from a Life at Disney Resources: Mitlin Financial: https://www.mitlinfinancial.com/ The JOY and Productivity Journal by Lawrence Sprung: https://www.amazon.com/JOY-Productivity-Journal-brought-mindset/dp/B0CYQFYW54/ Download Your Free Copy of the Couple's JOYful Money Guide: https://mitlin.us/CouplesJOY Connect with Larry Sprung:  LinkedIn: https://www.linkedin.com/in/lawrencesprung/ Instagram: https://www.instagram.com/larry_sprung/ Facebook: https://www.facebook.com/LawrenceDSprung/ X (Twitter): https://x.com/Lawrence_Sprung Connect with Lee Cockerell: LinkedIn: https://www.linkedin.com/in/LeeCockerell/ Instagram: https://www.instagram.com/leecockerellmagic/ Facebook: https://www.facebook.com/p/Lee-Cockerell-100070689116367/ Creating Disney Magic Facebook: https://www.facebook.com/createmagic/ Personal Website: https://www.leecockerell.com/ Cockerell Academy Website: https://www.cockerellacademy.com/ About our Guest: Lee Cockerell retired as the Executive Vice President of Operations for the WALT DISNEY WORLD® Resort in Lake Buena Vista, Florida, a position he held for ten years. His responsibilities encompassed a diverse mix of operations, which included 20 resort hotels with over 24,000 Guest rooms, 4 theme parks, 2 water parks, 5 golf courses, a shopping village & nighttime entertainment complex, the ESPN Sports Complex and the ancillary operations support functions. Lee joined the Disney organization in July 1990 as Director of Food and Beverage and Quality Assurance for the Disneyland Paris hotels. Prior to joining the Walt Disney World Co., he spent seventeen years in various executive positions with the Marriott Corporation and eight years with Hilton Hotels. Lee is the best-selling author of four books on leadership, management and world class customer service: Creating Magic: 10 Common Sense Leadership Strategies from a Life at Disney is now available in 21 languages. The Customer Rules: The 39 Essential Rules for Delivering Sensational Service is currently available in 15 languages. Time Management Magic: How to Get More Done Every Day Career Magic: How to Stay on Track to Achieve a Stellar Career Lee and his wife Priscilla reside in Orlando, Florida. Lee enjoys teaching leadership, management and service excellence seminars, traveling, dining out and most of all spending time with his three grandchildren, Jullian, Margot, and Tristan. Disclosure: Guests on the Mitlin Money Mindset are not affiliated with CWM, LLC, and opinions expressed herein may not be representative of CWM, LLC. CWM, LLC is not responsible for the guest's content linked on this site. This episode was produced by Podcast Boutique https://www.podcastboutique.com

AI is evolving so fast that it's hard to keep up—sparking both excitement and anxiety about the future of work. Will AI replace jobs, or will it redefine them?In this episode of [Un]churned, host Josh Schachter, SVP of Atlas at Gainsight, sits down with Jeffrey Bussgang, General Partner & Co-Founder at Flybridge Capital Partners and Senior Lecturer at Harvard Business School, and Teresa Anania, Chief Customer Officer at Sophos, who's been leading from the frontlines of AI-driven customer engagement. Together, they unpack the gap between the theory of AI transformation and the reality of implementation in large organizations. Jeff discusses how leaders can foster an “AI native” culture—one that encourages experimentation while valuing human judgment. Teresa shares a candid look into Sophos' AI journey, addressing the fears, resistance, and cultural shifts that come with change. She also highlights practical strategies to empower teams and enhance customer experiences through thoughtful automation.Whether you're a tech leader, customer success pro, or just AI-curious, this conversation is packed with actionable insights on embracing the future without losing the human touch.Timestamps: 0:00 - Preview0:48 - Meet Jeff & Teresa2:40 - The Impact of AI on Business Innovation5:00 - Fostering an AI-Driven Culture to Elevate Workforce Value16:10 - How AI Enables Rapid Prototyping19:40 - Balancing Human and AI Workflows21:50 - Quality Assurance and Customer Experience at Scale27:50 - Internal “Agent Assist” Solutions35:07 - Dynamics in Adopting AI Solutions______________________

I talk about last week's balance changes and my deck choices on he climb to Legend this month, before playing Mech Warrior on the ladder. You can find the deck import code below the following contact links.  You can follow me @blisterguy on Twitch, Bluesky, and Youtube. Join our Discord community here or at discord.me/blisterguy. You can support this podcast and my other Hearthstone work at Patreon here. # 2x (1) Slam # 1x (2) Crazed Alchemist # 2x (2) Part Scrapper # 1x (2) Quality Assurance # 2x (2) Safety Goggles # 2x (2) Shield Block # 2x (3) All You Can Eat # 2x (3) Boom Wrench # 2x (3) Mixologist # 2x (3) Wreck'em and Deck'em # 1x (4) Elise the Navigator # 1x (4) Nightmare Lord Xavius # 2x (5) Carnivorous Cubicle # 2x (5) Chemical Spill # 2x (6) Testing Dummy # 1x (7) Endbringer Umbra # 1x (8) Inventor Boom # 1x (0) Zilliax Deluxe 3000 #   1x (0) Zilliax Deluxe 3000 #   1x (4) Virus Module #   1x (5) Perfect Module # 1x (10) Tortolla #  AAECAZTxBgidoATHpAaRqAaTqAax/QbDgweCmAf1mAcLhqAEjtQE6J8Gh6AGj6gGkKgGkqgGlKgGhr8Gjr8GiuIGAAED9LMGx6QG97MGx6QG7t4Gx6QGAAA=

In this episode of PPC Live, Reva Minkoff shares her extensive experience in digital marketing, focusing on the importance of learning from mistakes in PPC campaigns. She discusses a significant error made during a Performance Max campaign, how it was turned into a learning opportunity, and the importance of understanding client goals. Reva emphasizes the need for a supportive environment where team members can share their failures and learn from them. The conversation also touches on the challenges posed by AI in PPC and the necessity of maintaining control over campaigns to align with client expectations.Takeaways:Learning from mistakes is crucial in digital marketing.Understanding client goals is key to successful PPC campaigns.Creating a supportive environment encourages team members to share failures.AI can introduce challenges in PPC that require careful management.Mistakes can lead to valuable learning opportunities.It's important to focus on what truly matters to clients.Communication with clients about mistakes can strengthen relationships.A structured QA process can help prevent errors in campaigns.Collaboration with other marketing teams enhances PPC effectiveness.Embracing a culture of learning from failures can drive success.Chapters00:00 Introduction to Reva Minkoff and Her Background03:55 The Importance of Learning from Mistakes07:54 Navigating Client Relationships and Expectations11:58 Understanding Client Goals and Metrics15:49 The Role of Collaboration in Marketing Success19:20 Navigating Campaign Goals and Conversions22:38 The Importance of Quality Assurance in Campaigns24:30 Creating a Safe Environment for Mistakes26:28 Learning from Failures and Client Goals28:13 The Role of AI in PPC Campaigns33:20 Reflections on a PPC Career JourneyFind Reva on LinkedInBook a coaching call with ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Anu⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠PPC Live The Podcast (formerly PPCChat Roundup) features weekly conversations with paid search experts sharing their experiences, challenges, and triumphs in the ever-changing digital marketing landscape.The next ⁠⁠⁠⁠⁠⁠⁠⁠⁠PPC Live London⁠⁠⁠⁠⁠⁠⁠⁠⁠ event is on October 22ndFollow us on ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow us on ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Twitter⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Join our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠WhatsApp Group⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Subscribe to our ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Newsletter⁠

The FDA Group's Nick Capman sits down with executive consultant Sean Gallimore to break down what makes medtech leaders and teams truly effective. Drawing from decades of experience across medical devices, diagnostics, CROs, and industrial technology, Sean shares his practical framework for leadership—the 4 Cs: Strategic Clarity, Capabilities, Compliance, and Connectedness—and how each one directly impacts growth, culture, and execution.Listeners will learn how to:Pressure-test whether your strategy is actually winnable.Match organizational capabilities to goals (and pivot when they don't).Use KPIs and OKRs to diagnose execution gaps.Build stronger trust and culture through connectedness, from “gemba” walks to multi-channel communication.Sean also shares real-world stories—from transforming an underperforming ultrasound launch to shifting a company's culture from “play not to lose” to “play to win.” Whether you're leading in medtech, life sciences, or beyond, this episode delivers actionable insights you can bring straight back to your team.About the Guest:Sean Gallimore, MBA is an executive consultant with 30 years of leadership across Fortune 500, mid-cap, and private equity–backed companies in medical devices, life sciences, and industrial technology. He has held senior roles at Medtronic, Smith & Nephew, Philips, Parexel, PDI Healthcare, and Dynisco, driving growth through strategy execution, turnarounds, innovation, and building high-performing teams. Today, he advises early-stage medtech companies on scaling operations, commercial strategy, and organizational development.About The FDA Group:The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

August 13, 2025: Eric Utzinger, Co-Founder and Chief Client Officer at Revuud, tackles the world of healthcare consulting. Drawing from 15 years in healthcare consulting, Eric reveals how the industry shifted around 2013, creating a system where traditional staffing firms often add little value beyond letterhead while charging substantial markups. What happens when technology enables direct access to pre-vetted talent pools? The conversation explores how marketplace platforms can eliminate intermediary costs while maintaining quality control, and why the assumption that higher costs equal better consultants may be costing health systems more than they realize. Eric addresses the critical balance between project success, talent vetting, and transparent pricing in an industry where finding the right IT expertise quickly can make or break major implementations. Key Points: 02:08 Challenges in Healthcare Consulting 04:53 Client and Talent Interaction 06:52 Vetting and Quality Assurance 09:56 Common Mistakes in Hiring Contractors X: This Week Health LinkedIn: This Week Health Donate: Alex's Lemonade Stand: Foundation for Childhood Cancer

Is your QA team really slowing down delivery, or are they just revealing the cracks in your development process? In this episode of Arguing Agile, we're talking about one of the most persistent myths in software development and reveal why QA teams are often unfairly blamed for systemic issues.We explore:The shift-left movement and why QA belongs in customer conversationsHow collaboration breakdowns create false bottlenecks Why treating QA as a cost center backfiresReal strategies for breaking the cycle of blameThe hidden value QA brings to lean startup principlesFrom waterfall thinking to modern agile practices, we break down why QA teams are actually your best allies in creating customer value - if you let them.#QualityAssurance #AgileCoaching #ProductManagementREFERENCESArguing Agile 211 - Communication is Product's Only Job)Arguing Agile 201 - Mastering Stakeholder Communication and ManagementArguing Agile 199 - W. Edwards Deming's Profound Knowledge for Transforming OrganizationsLINKSYouTube https://www.youtube.com/@arguingagileSpotify: https://open.spotify.com/show/362QvYORmtZRKAeTAE57v3Apple: https://podcasts.apple.com/us/podcast/agile-podcast/id1568557596Website: http://arguingagile.comINTRO MUSICToronto Is My BeatBy Whitewolf (Source: https://ccmixter.org/files/whitewolf225/60181)CC BY 4.0 DEED (https://creativecommons.org/licenses/by/4.0/deed.en)

In our latest podcast, we dive deep into the recruitment world with Mitch, a founder and specialist recruiter in Quality Assurance & Regulatory Affairs (QA/RA). If you're a hiring manager, candidate, or aspiring recruiter in the life sciences or medtech industries, this episode is packed with honest insights and practical advice. What you'll learn: Why Mitch chose to specialize in QA/RA The tension between client expectations and candidate realities How recruiters make their revenue (yes, we ask the money question!) Whether promoting open positions is still a challenge in 2025 Mitch's personal journey—education, family, and the struggles of building a business from scratch What he would do differently if he had to start again Whether you're considering using a recruiter or dreaming of launching your own hiring firm, this episode will help you understand what it really takes to go "from zero to one."

Ep 613 features Jen, a Quality Assurance and Training Manager with Chagrin Valley 911 Dispatch out of Ohio. Sponsored by INdigital - Facebook | LinkedIn | Twitter | Web Episode topics – Jen's path from criminal justice student to finding a lasting career in dispatch. The highs and lows of dispatcher training, including tough trainers and the importance of mentorship. Real stories about adapting to regionalized dispatch operations and handling high-stress situations. Calls that stick with dispatchers–from tragic emergencies to unexpectedly emotional moments. Lessons learned, advice for new dispatchers, and how the profession shapes the people behind the headset. If you have any comments or questions or would like to be a guest on the show, please email me at wttpodcast@gmail.com.

On this episode of the Inner Edison Podcast, host Ed Parcaut sits down with Leeroy Beeby, chartered accountant, entrepreneur, and founder of Checkthelevel.com—to talk about the real-world struggles and solutions in the world of small business finance. Leeroy shares his journey from South Africa to Bermuda to Canada, and how growing up in a family of serial entrepreneurs shaped his drive for innovation. He opens up about the challenges of building and managing remote teams, how introverts thrive in entrepreneurship, and the lessons learned from hiring (and firing) fast. Most importantly, Leeroy unpacks the most frequent—and expensive—bookkeeping mistakes businesses make, and how his company's “Grammarly for bookkeeping” is helping owners and bookkeepers catch errors before they snowball. You'll hear actionable advice for entrepreneurs and accounting professionals alike, plus candid takes on the reality of AI in bookkeeping, remote work culture, and why sustainable growth matters more than just getting bigger. Ready to feel more confident about your books? Grab your headphones and get ready to learn, laugh, and start seeing your financials in a whole new light! Try Checkthelevel.com with a 30-day free trial (no credit card required), and connect with Leeroy on LinkedIn or by emailing contact@checkthelevel.com. **Contact Ed Parcaut:** -

Metis Consulting Services ML Bradley welcomed Kara Harrison to the "Queens of Quality" podcast, where Kara Harrison shared her extensive career journey in quality assurance, from the USDA and FDA to various consulting roles. Both Kara Harrison and Metis Consulting Services ML Bradley discussed the evolution of the consulting industry, emphasizing the importance of clear client scope and the challenges posed by clients who insist on incorrect approaches. A key talking point centered on the misconception among sponsors that outsourcing absolves them of responsibility, particularly concerning vendor qualification and oversight, which directly contradicts regulatory guidelines such as ICH E6R3.

The FDA Group's Nick Capman sits down with Dr. Manfred Stapff—physician, author, and founder of Candid Advisory Inc., a consultancy specializing in real-world evidence and clinical development—for a wide-ranging conversation about how real-world data is reshaping drug development, regulatory decisions, and public understanding of evidence.Dr. Stapff draws on decades of experience across medical affairs, clinical trials, and RWE analytics to explain why real-world evidence isn't a replacement for randomized controlled trials—but a necessary complement. He outlines how to transform raw data into credible evidence, how the FDA is using RWE today, and why quality, transparency, and context are essential in data-driven science.He also offers cautionary insight on common pitfalls—from bias in training data and misinterpreted statistics to the challenges of AI integration in healthcare research.What they cover:What real-world evidence is (and isn't)—and how it differs from clinical trial dataHow RWE is being used by the FDA to support label expansions and safety monitoringKey risks around self-reported data, upcoding, and poor data qualityWhy statistical significance isn't enough—and how to evaluate clinical relevanceHow AI can accelerate pattern recognition and predictive diagnosticsWhy training data matters—and how bias can infiltrate large-scale AI toolsThe role of educated skepticism in interpreting data-driven claims in both science and societyDr. Manfred Stapff is the founder and principal consultant at a boutique advisory firm focused on real-world evidence strategy, clinical development, and medical data intelligence. He is the author of Real World Evidence Unveiled and a frequent speaker on the role of data integrity, statistical literacy, and AI in advancing medical research. His current work supports life science companies and investors in evaluating drug development strategies, acquisition opportunities, and data-driven innovations.The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit ⁠⁠https://www.thefdagroup.com⁠⁠

I discuss my top 5 cards from the Lost City of Un'Goro, before playing Mech Warrior on the ladder. You can find the deck import code below the following contact links.  You can follow me @blisterguy on Twitch, Bluesky, and Youtube. Join our Discord community here or at discord.me/blisterguy. You can support this podcast and my other Hearthstone work at Patreon here. # 1x (1) Sanguine Depths # 1x (2) Crazed Alchemist # 2x (2) Part Scrapper # 2x (2) Quality Assurance # 2x (2) Safety Goggles # 2x (2) Shield Block # 1x (2) Youthful Brewmaster # 1x (3) All You Can Eat # 2x (3) Boom Wrench # 1x (3) Latorvian Armorer # 1x (3) Mixologist # 1x (3) Wreck'em and Deck'em # 1x (4) Elise the Navigator # 1x (4) Griftah, Trusted Vendor # 1x (4) Nightmare Lord Xavius # 1x (4) Royal Librarian # 1x (5) Carnivorous Cubicle # 2x (5) Chemical Spill # 2x (6) Testing Dummy # 1x (7) Endbringer Umbra # 1x (8) Inventor Boom # 1x (0) Zilliax Deluxe 3000 #   1x (0) Zilliax Deluxe 3000 #   1x (4) Virus Module #   1x (5) Perfect Module # 1x (10) Tortolla #  AAECAZTxBhCcoASdoATOngbHpAaQqAaTqAaGvwaOvwan0waK4gbj5gax/QbDgweCmAeLmAf1mAcHjtQE6J8Gh6AGj6gGkagGkqgGlKgGAAED9LMGx6QG97MGx6QG6t4Gx6QGAAA=

Zendesk CEO Tom Eggemeyer joins Michael Krigsman to discuss the impact of AI CX on customer expectations. They explore real-world lessons from the Zendesk AI journey, including what has worked and what hasn't. Learn how customer service is being reshaped by ChatGPT and artificial intelligence and machine learning.Key Topics Covered:The shift from traditional chatbots to reasoning AI agentsWhy Zendesk only gets paid when AI successfully resolves issuesHow AI is more accurate (and sometimes more empathetic) than humansThe surprising ways AI is changing customer service metricsReal-world examples of AI successes and failuresThe future of work in an AI-dominated landscape

Try Fellow's AI Meeting Copilot - 90 days FREE - fellow.app/cooGuest: Lance Willett, Chief Quality Officer at AutomatticTopics Covered:How Automattic's open source culture evolved over 20 yearsWhat a Chief Quality Officer actually does—and why it mattersQuality = Craft × Context, and how that feedback loop scalesAutomattic's AI strategy: support bots, contextual UI, and site generationThe importance of tools like Linear and Storybook in enforcing qualityHow Automattic balances speed, risk, and governance with AI experimentationLessons from stabilizing Tumblr during its post-acquisition rebootPrioritization and the dangers of unbounded optimismLeadership takeaways from working closely with Matt Mullenweg

The HITRUST 2025 Trust Report sheds light on a critical question organizations continue to ask: can you really rely on a certification to mean what it says? According to Vincent Bennekers, Vice President of Quality, and Bimal Sheth, Executive Vice President of Standards Development and Assurance Operations at HITRUST, the answer comes down to one word: reliability.The conversation highlights how HITRUST goes beyond a simple checklist by layering in both threat intelligence and maturity modeling. Their framework isn't just built on abstract risk—it incorporates real-world attack techniques, aligning controls to the MITRE ATT&CK framework. This means that the certification reflects actual adversarial tactics rather than hypothetical risk scenarios.Bennekers shares that 99.41% of HITRUST-certified organizations did not report a breach in the last year, and that consistency over two annual reports points to meaningful outcomes—not just marketing claims. Sheth explains how each certification is reviewed in full by HITRUST, not just sampled, and every control is assessed for maturity—not pass/fail. It's a model that helps companies continuously improve, while also giving relying parties better information.For executive teams and boards, the report surfaces where organizations commonly struggle, including access control, vulnerability management, and third-party risk. It also highlights a growing use of external inheritance—leveraging cloud service providers' security posture—as a strategic move for organizations with tighter budgets.Looking ahead, the conversation points to continuous assurance and the evolving role of AI—both as a source of new risks and a tool to enhance security operations. HITRUST is already exploring certification models that reduce drift and increase visibility year-round.For organizations wanting to build more than just a paper shield, this episode unpacks how certification—done right—can be a strategic, measurable advantage.Note: This story contains promotional content. Learn more.Guests:Bimal Sheth, Executive Vice President of Standards Development and Assurance Operations at HITRUST | On LinkedIn: https://www.linkedin.com/in/bimal-sheth-248219130/Vincent Bennekers, Vice President of Quality at HITRUST | On LinkedIn: https://www.linkedin.com/in/vincent-bennekers-a0b3201/Host:Sean Martin, Co-Founder at ITSPmagazine and Host of Redefining CyberSecurity Podcast | https://www.seanmartin.com/______________________Keywords: sean martin, bimal sheth, vincent bennekers, hitrust, trust report, cybersecurity, compliance, certification, quality assurance, risk management, brand story, brand marketing, marketing podcast, brand story podcast______________________ResourcesHITRUST 2025 Trust Report: https://itspm.ag/hitrusz49cWebinar: Beyond the Checkbox: Rethinking SOC 2, Cybersecurity, and Third-Party Risk in 2025 — An ITSPmagazine Webinar with HITRUST (https://www.crowdcast.io/c/beyond-the-checkbox-rethinking-soc-2-cybersecurity-and-third-party-risk-in-2025-an-itspmagazine-webinar-with-hitrust)Visit the HITRUST Website to learn more: https://itspm.ag/itsphitwebLearn more and catch more stories from HITRUST on ITSPmagazine: https://www.itspmagazine.com/directory/hitrustLearn more about ITSPmagazine Brand Story Podcasts: https://www.itspmagazine.com/purchase-programsNewsletter Archive: https://www.linkedin.com/newsletters/tune-into-the-latest-podcasts-7109347022809309184/Business Newsletter Signup: https://www.itspmagazine.com/itspmagazine-business-updates-sign-upAre you interested in telling your story?https://www.itspmagazine.com/telling-your-story

  Background: From IT in India to MedTech in Norway  You have a pretty fascinating background – you studied computer applications/IT back in India and now you're a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?)  What were the biggest challenges when you switched into the medical devices field? For example, was there a steep learning curve with all the medical and regulatory jargon?  And conversely, do you think your IT background gives you any unique advantages in QARA? (Maybe in handling technical documentation or bringing a fresh perspective?)  Day-to-Day as a QARA Manager   Let's talk about what a QARA Manager actually does. What does a typical day or week look like for you as a Quality and Regulatory Affairs Manager? (For instance, are you reviewing a lot of documents, meeting with engineers, training colleagues, dealing with audits… all of the above?)  It would be great if you could mention some of the tools or software you use regularly. Are there specific QMS (Quality Management System) tools, document control systems, or even simple spreadsheets that are part of your daily routine?  We often hear that QA/RA folks are like the “internal police” in a company – some colleagues think you just spend days reading boring regulations and chasing them to follow rules (laughs). How true or untrue is that stereotype? How would you describe the role to someone who thinks it might be dry or overly bureaucratic?  On that note, an article I read actually said quality and regulatory roles are among the most dynamic and diverse in a company. You have to know a bit of everything – the tech, the laws, writing skills, you name it. What parts of the QARA role do you find most challenging, and which parts are the most rewarding?  (For example, is it challenging that the scope is so broad – one moment you're deep in engineering specs, next moment you're updating a regulatory policy? And rewarding perhaps when a product finally gets approved or when you prevent a big issue?)  First MedTech Role at Hy5Pro AS  Let's dive into your work experiences. Your first QARA role in Norway was at Hy5Pro AS, a startup developing a pretty cool product – a hydraulic prosthetic hand for amputees. What was it like stepping into Quality/Regulatory at a company making robotic hands?  (Feel free to explain what Hy5Pro's product was and your role there, e.g. implementing the quality system, getting certifications, etc.)  Do you have any memorable anecdotes from Hy5Pro? Perhaps a big challenge you faced early on or a funny incident while working on the prosthetic hand project. For instance, a lot of startups at that stage are trying to get their first ISO 13485 certification or pass initial regulatory hurdles – any story around that?  (e.g. “the day the auditors came for ISO certification” or a time something went wrong and how the team fixed it – anything that was a learning moment for you.)  Leading QARA at RemovAid AS   After Hy5, you moved on to RemovAid AS, which is another fascinating company – they created a device for removing contraceptive implants (a small gadget to help doctors remove those under-the-skin birth control implants). And I believe you were Head of Quality Assurance & Regulatory Compliance there. What were your main responsibilities at RemovAid, and how did it differ from your previous role?  RemovAid's product is a Class IIa medical device and was CE-marked under the new EU Medical Device Regulation. That sounds like a huge regulatory achievement. Can you share a proud moment from your time at RemovAid? For example, leading the company to ISO 13485 quality certification, or getting that CE approval, or the first time the device was manufactured at scale.  (We saw on LinkedIn you celebrated the first RemovAid device coming off a high-volume production line – feel free to tell that story!)  On the flipside, any tough or funny moments while at RemovAid? Perhaps juggling multiple roles in a small startup, or an unexpected problem that popped up (like a quirky product test failure or a documentation marathon just before a deadline)?  RemovAid is in women's health tech. Did working on a product aimed at female healthcare bring any special perspective or motivation for you? (Given it's about making contraceptive care easier – that's quite impactful.)  Consulting Experience at LINK Medical   Now, currently you're working at LINK Medical as a Medical Device Manager in their Quality/Regulatory team. So you went from being in-house at startups to a consulting role where you support multiple companies. What has that transition been like? How is life as a consultant different from working within a single company?  I imagine as a consultant you get to see a variety of projects – different devices, different teams – which can be exciting. Can you share any interesting experiences from your consulting work so far? Maybe an example of a cool project you helped on, or a common mistake you see companies making with QARA that you help fix, or even a humorous experience of jumping into a new company's project mid-stream.  Also, how do you manage your time and sanity when juggling multiple clients or projects? That sounds challenging – any personal tricks you've learned for staying organized when everyone needs your expertise at once? (laughs – “the consultant life”)*  Diversity and International Career Insights   I'd like to touch on diversity and your international experience. You're a woman in the medtech industry and you've built your career across two countries and cultures. Have you faced any unique challenges as a woman working in medical devices and QARA? And what about being an international professional – any cultural adjustments or advantages you've noticed working in Norway compared to India?  The medtech industry, especially in leadership, still isn't very diverse – I read that less than a quarter of executive roles in medtech are held by women. How do you feel about the state of diversity in our field? Are things improving, and have you seen progress during your career?  What advice would you give to companies or teams to foster a more inclusive environment, especially in fields like quality and regulatory? (Since those teams often work with all departments, they can influence company culture too.)  Rapid-Fire Round   Host: Okay, Pardeep, to wrap up on a fun note, we have a rapid-fire round! I'll ask you a series of quick questions and you answer with the first thing that comes to mind. Ready? (brief pause) Go!  Question 1: What's one thing about your job that most people would be surprised to learn?  Question 2: What's the coolest medical device or gadget you've worked on or seen so far?  Question 3: Are you team coffee or tea? (What fuels your workdays?)  Question 4: Is there a quality/regulatory jargon or acronym you think is funny or confusing (and what does it actually mean)?  Question 5: If you weren't in QARA, what alternate career could you see yourself in?  Question 6: What's one Norwegian word or phrase you've picked up that you love to use? (Bonus: translate it for us!)*  Question 7: If your career journey were made into a movie title, what would it be? (Just for fun!)  (Guest gives rapid-fire answers with laughter and brief commentary.)  Advice and Closing   Now, before we sign off, I want to circle back to a more reflective note. What advice or words of inspiration do you have for junior professionals, students, or even folks thinking of switching careers into Quality and Regulatory in medtech? For someone listening who says, “This sounds interesting but also a bit overwhelming,” how can they prepare and what should they expect?  (For example, should they get familiar with certain regulations or take courses? Find a mentor? Be ready to continually learn? Share any practical tips.)  And maybe equally important, what should they not be scared of? People might think “Oh, I'm not a science or law expert, can I do this?” – any encouragement to help them overcome that hesitation?      Podcast Interview Questions for Pardeep Kaur (Reg compliance manager Oslo University Hospital)  Welcome & Setup  Can you briefly introduce yourself and describe your current role as a Quality & Regulatory Affairs Manager?  Career Journey  How did you go from earning a Computer Applications/IT degree in India to a QARA career in Norway?  What motivated you to switch into medical device regulations, and what were the biggest initial challenges?  In what ways has your IT background helped you excel in QARA?  Day-to-Day Responsibilities  What does a typical day or week look like for you as a QARA Manager?  Which tools or software (QMS systems, document controls, etc.) do you rely on most?  Is it true that QA/RA professionals are the “internal police”? How would you describe the role to someone who thinks it's all paperwork?  Which aspects of QARA do you find most challenging, and which are the most rewarding?  Hy5Pro AS Experience  What was it like implementing QARA at Hy5Pro, developing a hydraulic prosthetic hand?  Can you share a memorable “learning moment” or funny anecdote from your time there?  RemovAid AS Experience  At RemovAid, you led Quality & Regulatory for a Class IIa implant-removal device—what were your core responsibilities?  Describe a proud milestone (e.g., ISO 13485 certification or CE marking) and the story behind it.  Any unexpected or humorous challenges you overcame in that role?  How did working on a women's health product impact you personally?  LINK Medical Consulting  How has transitioning to a consulting role at LINK Medical differed from in-house QARA positions?  What's a standout project or recurring compliance issue you help clients solve?  How do you stay organized when juggling multiple clients and deadlines?  Diversity & International Insights  As a woman in medtech QARA, have you faced any unique challenges or opportunities?  What cultural adjustments did you experience moving from India to Norway?  How can medtech teams become more inclusive, especially in QA/RA?  Rapid-Fire Round  (Answer quickly with the first thing that comes to mind.)  One surprise fact about your job?  Coolest device or gadget you've worked on or seen?  Favorite (or funniest) QARA acronym—what does it mean?  Alternate career you might have chosen?  Norwegian word or phrase you love—translate it for us!  If your career were a movie title, what would it be?  Closing Advice  What practical steps should students or career-changers take to break into QARA?  What misconceptions shouldn't they be afraid of when considering this field?   

On Episode #173 of the PricePlow Podcast, Mike and Ben dive deep into the world's most researched supplement with Mirko Holzmüller and Stefan Schweyer from Creapure, the premium creatine monohydrate brand manufactured by AlzChem in Germany. This comprehensive conversation explores everything from the unique German manufacturing process that delivers 99.99% purity to the expanding research showing creatine's benefits far beyond athletic performance. As creatine experiences a renaissance with growing interest from women, elderly populations, and health-conscious consumers, Mirko and Stefan provide insider insights into what sets Creapure apart from generic alternatives. From the coal-and-lime production process in Bavaria to the rigorous testing protocols that ensure every batch meets pharmaceutical-grade standards, this episode reveals why leading brands like Nutristat choose Creapure as their exclusive creatine source. The discussion covers optimal dosing strategies, debunks common myths about loading phases, and explores emerging research on post-viral fatigue, cognitive function, and healthy aging. Whether you're a supplement industry professional or someone curious about creatine's expanding applications, this conversation offers unprecedented access to the science and manufacturing expertise behind the world's most trusted creatine brand. https://blog.priceplow.com/podcast/creapure-173 Video: Inside Creapure - The Science of Premium Creatine Manufacturing https://www.youtube.com/watch?v=rJe2nesRtkw Detailed Show Notes: Creapure's Manufacturing Excellence and Scientific Leadership (0:00) – Introduction: Meeting the Creapure Team (5:00) – AlzChem's Foundation: More Than Just Creatine (10:00) – Creatine Fundamentals: Energy Currency for Body and Brain (15:00) – Personal Dosing Strategies: Beyond the Standard Five Grams (20:00) – Understanding Creatine's Unique Energy Profile (25:00) – Manufacturing Excellence: The German Advantage (30:00) – Purity Standards: 99.99% Excellence (35:00) – Quality Control and Contamination Prevention (40:00) – Market Trends and Consumer Education (45:00) – Research Partnerships and Scientific Leadership (50:00) – Creatine Forms and Research Evidence (55:00) – Practical Use and Dosing Strategies (60:00) – Product Forms and Delivery Methods (65:00) – Quality Assurance and Brand Protection (70:00) – Regulatory Compliance and Health Claims (75:00) – Future Directions and Consumer Access Where to Follow Creapure and Learn More Creapure Website: Creapure.com Instagram: @Creapure Email: info@creapure.com Mirko Holzmüller: LinkedIn Stefan Schweyer: LinkedIn Educational Resources: Creapure Manufacturing Process AlzChem Company Overview ... Read more on the PricePlow Blog

TakeawaysQuality assurance is crucial in coffee roasting.Cupping is essential for coffee quality.You need to taste your own coffee.Cupping should be a priority in your business.Learn to cup, then cup to learn.Make cupping enjoyable and accessible.Invest in basic quality control tools.Cupping with peers enhances learning.Practice is key to improving your cupping skills.Production brewing can be more effective than cupping.   Visit and Explore Covoya! TAKE OUR LISTENER SURVEY

Dr. Renee Coffman is president and co-founder of the Nevada College of Pharmacy, now Roseman University of Health Sciences. She previously served as the University's Executive Vice President for Quality Assurance and Intercampus Consistency and the Dean of its College of Pharmacy. Before establishing Roseman University, Dr. Coffman became a founding member of the faculty at Western University of Health Sciences, where she also held the position of Facilitative Officer for Student Services. While at Western, Dr. Coffman and four colleagues received Honorable Mention for the AACP Innovations in Teaching Awards. A licensed pharmacist in the state of Nevada, Dr. Coffman earned a Pharmacy degree from OhioNorthern University in 1987 and, following graduation, worked as a pharmacist in her hometown of Bucyrus, Ohio and in Piqua, Ohio. In 1995, Dr. Coffman earned a doctoral degree in Industrial and Physical Pharmacy from Purdue University, where she received the Kienle Award for Excellence in Teaching, the Jenkins-Knevel Award for Outstanding Graduate Research, and was awarded an AAPE-AFPE Association Fellowship in Pharmaceutical Sciences.Dr. Coffman is a member of the American Association of Colleges of Pharmacy, American Pharmaceutical Association, American Association of Pharmaceutical Scientists, the American Society of Health System Pharmacists, and the International Federation of Pharmacy, as well as Phi Kappa Phi and Rho Chi Honor Societies and the Phi Lambda Sigma Pharmacy Leadership Society. Dr. Coffman has worked to support pharmacy, education, and improved health care through herwork with the Southern Nevada Medical Industry Coalition, iDO (Improving Diabetes and Obesity inSouthern Nevada), the Nevada State Board of Pharmacy Medication Error Discussion Group, and theNevada State Board of Pharmacy Committee on Standards for Approval of Pharmacy Technician Training Programs. Additionally, Dr. Coffman was instrumental in successful legislative efforts permitting pharmacists to perform finger-stick blood glucose testing. In recognition of her community service in Southern Nevada, in 2008, she received the “Who's Who in Healthcare” Award and the “Women of Distinction” Award, both sponsored by In Business Las Vegas, now VEGAS INC. In 2017, the publication recognized Dr. Coffman as one of 12 “Women to Watch” in business. In 2012, she was named a “Distinguished Alumnus” by Ohio Northern University and in 2021 was named a “Distinguished Alumnus” by Purdue University.

In this episode of the Drop In CEO podcast Jay Schumann shares his expertise in corporate microbiology, food safety, and quality assurance. The conversation covers Jay's career journey, key leadership lessons, and the importance of being a lifelong learner. Jay emphasizes the value of humility, continuous learning, and investing in people, offering practical advice for both current and aspiring C-Suite leaders. The episode also highlights the significance of aligning with a company's values and the critical role of cultural understanding in achieving professional success. Episode Highlights: 05:31 Climbing the Corporate Ladder at PepsiCo 09:46 Insights on Leadership and People Management 23:53 Defining Lifelong Learning and Wisdom 25:48 Acquiring Knowledge Through Various Methods 29:28 The Role of Humility in Learning and Leadership 36:53 Finding Credible Sources of Information Jay Schuman is a seasoned senior leader in Corporate Food Safety and Microbiology with over 30 years of experience in the food and beverage industry. Known for his high integrity and science-based, practical approach, Jay has led global teams and labs supporting new product innovation, risk mitigation, compliance, and quality assurance for major CPG brands. He excels at designing and implementing microbial food safety programs, harmonizing standards across regions, and fostering GFSI-compliant food safety cultures. A trusted people leader and strategic thinker, Jay is passionate about cross-functional collaboration, continuous improvement, and building strong, values-driven teams that drive business results. Connect with Jay Schuman: LinkedIn: www.linkedin.com/in/jay-schuman For more information about my services or if you just want to connect and have a chat, reach out at: https://dropinceo.com/contact/See omnystudio.com/listener for privacy information.

In this episode, Raul dives into the journey of Cynthia Abbott Kerr and Richard Kerr, the power couple behind Wellpay AI. Cynthia, a former corporate executive, shares how a trip to Japan and Rich's encouragement led her to start a business focused on helping other companies design and align their pay strategies using AI. The discussion touches on the complexities of building an AI-driven company, especially in a highly regulated industry, and how Wellpay AI addresses these challenges. Richard brings his extensive AI expertise to the table, emphasizing the importance of security and continuous learning in their technology. They also explore the future of work, how AI is transforming traditional roles, and the essential skills needed in this evolving landscape. Tune in to learn about their innovative approach to compensation consulting and the role of AI in making strategic business decisions.00:16 Cynthia's Journey to Founding Wellpay AI01:54 Building an AI Company: Challenges and Strategies03:13 AI in Compensation: Ethics and Compliance03:56 Rich's Expertise in AI Development05:35 Strategic Use of AI in Business10:41 Business Model and Pricing Strategy16:40 Quality Assurance in AI Systems18:08 Communicating Value to Clients18:37 Efficiency and Speed in Consultancy20:38 The Future of Work and Technology23:59 Leadership and AIConnect with Cynthia and Rich: • https://www.wellpay.ai/• https://www.linkedin.com/in/cynthiawellpay/• https://www.linkedin.com/in/datasciencedoc/ Connect with Raul: • Work with Raul: https://dogoodwork.io• Growth Resources: https://dogoodwork.io/resources• Connect with Raul on LinkedIn (DMs open): https://www.linkedin.com/in/dogoodwork/