Shows
Queens of Quality PodcastQuality: Scopes, Approaches, and OversightsMetis 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 E6R3.2025-07-2822 min
Queens of Quality PodcastWish lists and action itemsForest Flodin and Michelleanne talk about how we wish projects could go, and what some of the stumbling blocks are along the way.2025-07-0842 min
Queens of Quality PodcastData Management looks to the futureThis week joined by Nicole Latimer, CEO of Medrio. What do we see as we look to the future.2025-06-3025 min
Queens of Quality PodcastThe path to Data IntegrityWhat do we need to ensure data integrity? How do we get there? What are some pieces we can avoid along the way?2025-06-2334 min
Queens of Quality PodcastThe importance of DMMichelleanne and Katrina and Data Management and Quality!2025-06-1635 min
Queens of Quality PodcastSame approach will always provide the same outcome.Matt Bodo and Michelleanne discuss how we have yet to move the needle and why.2025-06-0933 min
Queens of Quality PodcastFixers and Bio-Business, with Lucia MokresQueens of Quality Returns for Season 3!
My first guest is Dr Lucia Mokres of Araneae Consulting.
Welcome!2025-06-0228 min
The Tattooed BuddhaGetting to Know Holly HerringSend us a textWe meet with Holly Herring---one of our columnists for The Tattooed Buddha. We chat about Holly's work with those that are homeless, her journey to being a writer and the process of writing. We also learn about how Holly and Michelleanne Bradley met and became friends, which in turn led her to write for The Tattooed Buddha!The post Getting to Know Holly Herring appeared first on The Tattooed Buddha.Follow us on Facebook and Instagram! Interested in being a guest on our podcast? Contact us at editor@thetattooedbuddha...2024-02-2934 min
The Tattooed BuddhaGetting to Know Holly HerringWe meet with Holly Herring---one of our columnists for The Tattooed Buddha. We chat about Holly's work with those that are homeless, her journey to being a writer and the process of writing. We also learn about how Holly and Michelleanne Bradley met and became friends, which in turn led her to write for The Tattooed Buddha!
The post Getting to Know Holly Herring appeared first on The Tattooed Buddha.2024-02-2934 minThe Tattooed BuddhaGetting to Know Holly HerringSend us a textWe meet with Holly Herring---one of our columnists for The Tattooed Buddha. We chat about Holly's work with those that are homeless, her journey to being a writer and the process of writing. We also learn about how Holly and Michelleanne Bradley met and became friends, which in turn led her to write for The Tattooed Buddha!Sit back and hear more about Holly and some of her stories.Beggars: The Right and Need to Choose There is Compassion in Harm Reduction {Trigger Warning}Want to...2024-02-2934 min
Queens of Quality PodcastUnlocking Ethical AI in Life Sciences: Insights with Steve Thompson PT4In this episode of Queens of Quality, co-hosts Michelleanne and Jen engage with guests Emily Barker and Steve Thompson in a conversation on AI and ethics. Major topics include AI's difficulty in dealing with negative constructs, limitations, and the role of the Algorithm Review Board (ARB). The team frames the conversation by comparing AI to different aspects of human behavior, illustrating its limitations. They delve into negative programming and its implications on pattern matching in AI. The episode also highlights the importance of a diverse cross-section of people in ARB to minimize bias and raise various ethical c...2024-02-2027 minQueens of Quality PodcastUnlocking Ethical AI in Life Sciences: Insights with Steve Thompson and Emily Barker PT3In this episode, the hosts, Michelleanne and Jenn, continued their conversation with Steve Thompson and special guest Emily Barker, an experienced tech professional focusing on biopharma, biotech, and AI. They discussed Emily's unique perspective, bringing tech and biopharma together, delving further into AI ethics, and creating an algorithm review board. They spoke on using AI ethically and avoiding potential catastrophes. The podcast touched on the constant evolution of AI, the careful and informed approach to its use in the life sciences field, and the importance of bringing together diverse perspectives to shape its future in a beneficial manner. They...2024-01-3027 minQueens of Quality PodcastUnlocking Ethical AI in Life Sciences: Insights with Steve Thompson PT2In this episode of "Queens of Quality," hosts Michelleanne, Jen, and guest Steve Thompson delve deeper into the ethical implications of AI in life sciences. They emphasize the necessity of an Algorithm Review Board (ARB) to oversee the ethical use of AI in clinical trials and beyond. Acknowledging the rapid evolution of technology and its complex application in healthcare, they stress the importance of collaboration and diverse representation to ensure ethical practices.Tune in!During this episode, you will learn about;00:31 Introduction and Welcome Back00:40 Discussion on AI and Clinical Trials2024-01-0926 minQueens of Quality PodcastUnlocking Ethical AI in Life Sciences: Insights with Steve ThompsonIn this engaging episode of "Queens of Quality," Michelleanne welcomes Steve Thompson to delve into the realm of ethical AI in life sciences. They explore the excitement and challenges surrounding AI's evolution, emphasizing the critical need for an ethical compass in its application. With insightful discussions on bias, data integrity, and the multidisciplinary approach necessary for success, Steve and Michelleanne highlight the intricate balance between technological advancement and ethical responsibility. Their conversation teases a promising solution, promising a deeper exploration in the next episode.Tune in!During this episode, you will learn about;0:00:32...2023-12-1930 minQueens of Quality PodcastEmbracing Evolution and Growth in QualityJoin Michelleanne and Jenn in the Season 2 finale of Queens of Quality as they reflect on the evolution of quality and compliance in the pharmaceutical industry. Dive into insightful discussions on soft skills, inspection readiness, regulatory changes, and the importance of simplicity in this dynamic field. Get ready for engaging conversations and a sneak peek into what's ahead in the next season! Tune in! During this episode, you will learn about;0:00:32 - Introduction and Season Wrap-up0:01:07 - Discussion on Soft Skills in Quality0:02:45 - I...2023-11-2116 minQueens of Quality PodcastA Journey through the Pharmaceutical Regulation and Quality DesignWelcome to another episode of Queens of Quality. In this episode, we explore the key concepts of ICH (International Council on Harmonization), with a focus on the recent revisions to ICH E6R3 and ICH E8R1. These revisions bring significant changes to the pharmaceutical industry's regulatory landscape, emphasizing the importance of quality by design in clinical trials.Tune in!During this episode, you will learn about;0:00:49 - ICH Introduction0:02:13 - The Significance of ICH E6 and E80:04:41 - The Global Impact of ICH 0:08:02 - The Evolution o...2023-10-2423 minQueens of Quality PodcastRevolutionizing the REMS Industry with Sherice MillsWelcome to another episode of Queens of Quality. Join us in this podcast episode as we decode compliance and quality assurance complexities in the pharmaceutical and biotech industries with Sherice Mills, founder of ADROIT Risk Management. Sherice enlightens us on the evolution of REMS programs, their importance in patient safety, and the role of the FDA. We also delve into the challenges in leadership and innovation in these industries and the need for a partnership mentality for revolutionary ideas. The episode further explores the changing expectations of the FDA from vendors, the impact on patient safety, and the need...2023-10-1032 minQueens of Quality PodcastThe Evolution of Compliance in Biotech and Pharma with Cheryl McCarthyIn this episode of Queens of Quality, the hosts interview Cheryl McCarthy, a seasoned professional in the pharmaceutical and biotech industries. They discuss the complexities of quality and compliance, the new ICHU6R3 guidance, and the importance of explaining the rationale behind actions. The conversation also explores the evolution of quality control, the integration of Agile methodology, and the shift in quality culture towards collaboration. They conclude by discussing the role of auditors, the potential benefits of constructive feedback, and the learning opportunities presented by audits.Tune in!During this episode, you will learn about;2023-09-2628 minQueens of Quality PodcastFrom Bench to Bedside: Navigating Failures and Triumphs in Pharma and BiotechIn this episode of the Queens of Quality podcast, we explore the importance of discussing failure alongside success in the pharmaceutical and biotech industries. With only a small percentage of drugs making it to clinical testing, failure is an integral part of the industry. We discuss the lengthy process of bringing a product to market, the challenges faced, and the significance of collaboration between academia and the industry. Join us as we delve into the complexities of drug development and the lessons learned from failures. Don't forget to subscribe, like, review, and share the podcast to help us continue...2023-09-1231 min
The Tattooed BuddhaMeeting Others (and Myself) with CompassionSend us a textMichelleanne Bradley talks about feeling the anxiety of traveling. Seeing people rush around the airport and the feelings that accompany that, she discusses how realizing the need to face people with kindness and compassion. This translates to everyday life, not only travel. What if we not only take care of others with this compassion and […]The post Meeting Others (and Myself) with Compassion {Dharma Talk} appeared first on The Tattooed Buddha.Follow us on Facebook and Instagram! Interested in being a guest on our podcast? Contact us at editor@th...2023-08-3009 minThe Tattooed BuddhaMeeting Others (and Myself) with Compassion {Dharma Talk}Send us a textMichelleanne Bradley talks about feeling the anxiety of traveling. Seeing people rush around the airport and the feelings that accompany that, she discusses how realizing the need to face people with kindness and compassion. This translates to everyday life, not only travel. What if we not only take care of others with this compassion and grace, but what if we also take care of ourselves with that same grace?Follow us on Facebook and Instagram! Interested in being a guest on our podcast? Contact us at editor@thetattooedbuddha.com.2023-08-3009 minQueens of Quality PodcastLeadership Support and Inspection Readiness: Ensuring Organizational ExcellenceLeadership Support and Inspection Readiness: Ensuring Organizational ExcellenceIn this enlightening episode of "Queens of Quality," hosts Michelleanne and Jenn delve into the pivotal role of leadership support in achieving operational efficiency, inspection readiness, and organizational success. They discuss the often underestimated impact of leadership in various areas, including resources, teamwork, communication, and preparedness. Discover how leadership support can foster a culture of open communication, acknowledge imperfections, and drive excellence across departments. Join the conversation as they share valuable insights into effective leadership practices and the key to maintaining a balanced, successful organization....2023-08-2932 minQueens of Quality PodcastA Comprehensive Guide to Audits and Compliance in PharmaceuticalsThis podcast episode, hosted by Jen and Michelleanne, dives deep into the intricacies of pharmaceutical and biotech industries, focusing on audits, vendor qualifications, and quality compliance. The hosts unravel how health authorities are intensifying their involvement in vendor collaborations, the increasing importance of contract owners in the qualification process, and the instances where qualification audits become vital for organizations. The episode also delves into vendor qualification and audit scheduling, the role of SOPs and quality manuals, and the challenges of vendor reassessment during mergers and integrations. The conversation concludes with an exploration of respect, empathy, transparency, and open communication...2023-08-1537 minQueens of Quality PodcastCultivating a Quality Culture in Pharma and BiotechEver thought about the crucial role culture plays in the pharmaceutical and biotech industries? What if we told you it's not just about hiring quality people but also about cultivating an atmosphere of strong communication, compliance, and a deep understanding of roles and responsibilities? Welcome to season two of Queens of Quality. In our latest episode, we dissect this complex subject, peeling off the layers that often lead to group dynamics and group thinking pitfalls. We share some insights on creating a culture that doesn't just dwell on 'do what I say' but promotes trust and objectivity. 2023-08-0130 minThe Tattooed BuddhaWomen in Buddhism (Part I)Send us a textToday we have some guests on our podcast to discuss the role of women in Buddhism. Dana and Michelleanne talk with Mary Stancavage, Holly Herring and Ayya Yeshe. We share how we all came to practice, our history with this practice and belief in God, the types of Buddhism we all practice. Women play an integral role in Buddhism and we discuss this and the lack of teachings and access that nuns and lay women can face. More about Mary Stancavage here: https://marystancavage.org/about-mary-stancavage/Find Holly Herring's writings...2023-02-0847 minQueens of Quality PodcastRisk Evaluation and Mitigation Strategy (REMS)Join in another fantastic episode with your hosts, Jennifer and Michelleanne. In today’s episode, we talk about Risk Evaluation and Mitigation Strategy (REMS). We talk about the history of Thalidomide and why REMS closely monitors it. Moreover, we discuss the different pieces of REMS and the difference between Single REMS & Shared REMS.Additionally, we talk about the difference between Pharmacovigilance (PV) & REMS, The REMS Industry Consortium (RIC), and how to get started with a REMS program. Tune in! During this episode, you will learn about;[00:30] Episode intr...2022-09-0728 minQueens of Quality PodcastPharmacovigilancePharmacovigilance is the process of monitoring the effects of medical drugs after they have been licensed for use, especially to identify and evaluate previously unreported adverse reactions.Welcome to another incredible episode with your hosts, Jennifer and Michelleanne. In this episode, we focus on pharmacovigilance in the pharmaceutical industry. We talk about who is responsible for drug safety & pharmacovigilance, the sources of pharmacovigilance data, and pharmacovigilance in clinical trials. In addition, we discuss the Investigator’s Brochure (IB) and Adverse Event (AE) reporting policy and share how you can turn pharmacovigilance into a competitive advantage.2022-08-2426 minQueens of Quality PodcastAdopting A Proactive Approach to Quality and ComplianceAdopting a proactive approach is one of the most important decisions any organization can make. It helps the organization to become more profitable and competitive. In addition, companies that adopt a proactive approach to quality and compliance can identify potential issues before they become problems and reduce the number of problems that arise in the future.Welcome to another incredible episode with your hosts, Jennifer and Michelleanne. Today’s episode discusses adopting a proactive approach to quality and compliance. We talk about the most significant learnings from COVID-19, acknowledging workplace mistakes, and the importance of forgiveness in th...2022-08-1023 minQueens of Quality PodcastThe Regulatory LandscapeWelcome to another fantastic episode with your hosts, Jennifer and Michelleanne. In today’s episode, we talk about the regulatory landscape of the pharmaceutical industry. We focus on the role of regulatory organizations and the changes that have taken place in the regulatory process since the development of the polio vaccine. Additionally, we talk about the relationship between quality and regulatory and the importance of leveraging your regulatory department. Finally, we discuss whether firm size affects regulatory requirements and how people can ensure that they have solutions that are fit for purpose. Tu...2022-07-2736 minQueens of Quality PodcastThe Ultimate Guide to Audit and Inspection ReadinessThe audit and inspection readiness is a process of assessing the readiness of organizations to conduct an audit or inspection. It helps ensure that organizations are ready for an audit by evaluating the risk level and identifying potential problems that could lead to audit failures. Moreover, it helps organizations identify areas for improvement so they can be more efficient in their operations.Welcome to another amazing episode with your hosts, Jennifer and Michelleanne. In today’s episode, we talk about the importance of inspections and audits, identifying the right people to be in front of an inspector, an...2022-07-1428 minQueens of Quality PodcastQuality and Compliance in The Pharmaceutical IndustryThe pharmaceutical industry is highly regulated. Regulatory agencies require pharmaceutical companies to meet specific standards of quality and compliance. It is thus important to have a thorough understanding of what these words mean and how they are related to each other.Welcome to this amazing episode of the “Queens of Quality” podcast with your hosts, Jennifer and Michelleanne. In this episode, we share why we created the ‘Queens of Quality’ podcast and our perspectives on the difference between compliance and quality. Additionally, we talk about the importance of effective communication within an organization and why compliance and quality...2022-06-2923 minQueens of Quality PodcastWelcome to Queens of Quality PodcastWelcome to the Queens of Quality podcast with your hosts, Michelleanne Bradley & Jennifer DiMarco. This podcast will discuss some of the basic and not-so-basic impacts of compliance and quality within the pharmaceutical and biotech industries.Join us in our biweekly podcast episodes, where we will provide direction and be trust advisors for solutions for day-to-day issues. Additionally, we will add a balance of laughter and education as we discuss and debunk some of the misconceptions about quality assurance in the pharmaceutical industry. Don’t forget to Subscribe, Rate, Review, Like, and Share!2022-06-2801 min