Queens of Quality Podcast – Détails, épisodes et analyse

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Queens of Quality Podcast

Michelleanne Bradley

Business & Entrepreneuriat

Éducation

Fréquence : 1 épisode/45j. Total Éps: 26

Quality and compliance are often seen as rigid within an organization. Every company has ‘em; nobody wants ‘em, but it’s even more imperative to implement them. Join Michelleanne, host of Queens of Quality, and guests as they discuss topics in reasonable and, at times, light-hearted delivery. Receive insight on how these requirements can be implemented in a compliant, scale-able, and sustainable manner for organizations at any point within the company life cycle. Every episode we will provide solutions for day-to-day issues to debunk some of the misconceptions about Quality Assurance. Subscribe to the show to stay up to date with new episodes.

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🇫🇷 France - careers
15/07/2026
#83
🇫🇷 France - careers
14/07/2026
#46

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Liens partagés entre épisodes et podcasts

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https://www.linkedin.com/company/metis-consulting-services/
32 partages
https://www.linkedin.com/in/stevethompsonsocal/
8 partages
https://www.linkedin.com/in/mannbark/
4 partages

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Score global : 52%

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Quality: Scopes, Approaches, and Oversights

Saison 3 · Épisode 7

lundi 28 juillet 2025 • Durée 22:31

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.

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Wish lists and action items

Saison 3 · Épisode 6

mardi 8 juillet 2025 • Durée 42:25

Forest Flodin and Michelleanne talk about how we wish projects could go, and what some of the stumbling blocks are along the way.

Unlocking Ethical AI in Life Sciences: Insights with Steve Thompson

Saison 2

mardi 19 décembre 2023 • Durée 30:53

In 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 - Introduction and Guest Introduction (Steve Thompson) - Discussing the Importance of Ethical AI

0:01:47 - Guest's Background and Journey into AI

0:02:11 - The Current State and Future of AI

0:03:22 - The Ethical Dilemmas in AI

0:05:34 - The Importance of Continuous Improvement in AI

0:11:35 - The Challenges of Creating Synthetic Patients

0:13:32 - The Role of AI in Risk Management

0:18:48 - The Importance of Multidisciplinary Teams in AI

0:24:30 - The Ethical Considerations in AI

0:28:48 - Conclusion and Teaser for Next Episode

Love the show? Subscribe, Rate, Review, Like, and Share!

Let’s Connect!

Connect with Steve Thompson

LinkedIn: https://www.linkedin.com/in/stevethompsonsocal/

Connect with Queens of Quality;

Website: https://metisconsultingservices.com/
LinkedIn: https://www.linkedin.com/company/metis-consulting-services/

Email:

hello@metisconsultingservices.com

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Embracing Evolution and Growth in Quality

Saison 2 · Épisode 8

mardi 21 novembre 2023 • Durée 16:20

Join 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-up

0:01:07 - Discussion on Soft Skills in Quality

0:02:45 - Insights on Inspection Readiness

0:04:03 - Changes in Regulations and Future Trends

0:06:44 - The Importance of Being a Quality Human Being

0:08:25 - The Need for Quality in Every Role

0:10:44 - Conclusion and Look Forward to Next Season

Love the show? Subscribe, Rate, Review, Like, and Share!

Let’s Connect!

Connect with Queens of Quality;

Website: https://metisconsultingservices.com/
LinkedIn: https://www.linkedin.com/company/metis-consulting-services/
Email: info@metisconsultingservices.com

A Journey through the Pharmaceutical Regulation and Quality Design

Saison 2 · Épisode 7

mardi 24 octobre 2023 • Durée 23:50

Welcome 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 Introduction

0:02:13 - The Significance of ICH E6 and E8

0:04:41 - The Global Impact of ICH

0:08:02 - The Evolution of Technology

0:11:30 - Quality by Design

0:18:51 - Operational Feasibility

0:21:16 - Complementary Guidance

Love the show? Subscribe, Rate, Review, Like, and Share!

Let’s Connect!

Connect with Queens of Quality;

Website: https://metisconsultingservices.com/
LinkedIn: https://www.linkedin.com/company/metis-consulting-services/
Email: info@metisconsultingservices.com

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Revolutionizing the REMS Industry with Sherice Mills

Saison 2 · Épisode 6

mardi 10 octobre 2023 • Durée 32:30

Welcome 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 for trusted advisors. Don't miss out on this informative conversation.

Tune in!

During this episode, you will learn about;

0:00:32 - Guest introduction: Sherry Mills, founder of Adroit Risk Management.

0:01:39 - Discussion about the history and origins of REMS programs.

0:04:14 - Mention of the FDA's authority to require additional safety measures.

0:06:03 - Explanation of the various components of REMS programs.

0:09:12 - Discussion on the challenges of standardizing REMS programs globally.

0:16:33 - Challenges in Leadership and Innovation

0:18:58 - Addressing resistance to change within the pharmaceutical industry.

0:20:23 - Importance of in-house expertise and trusted advisors.

0:24:16 - Reference to the REMS Industry Consortium (RIC) and the need for industry collaboration.

0:27:46 - Mention of upcoming workshops and exploration of AI in the industry.

0:31:56 - Closing remarks and contact information.

Love the show? Subscribe, Rate, Review, Like, and Share!

Let’s Connect!

The Evolution of Compliance in Biotech and Pharma with Cheryl McCarthy

Saison 2 · Épisode 5

mardi 26 septembre 2023 • Durée 28:18

In 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;

0:00:32: Introduction of the first-ever guest, Cheryl McCarthy, her background, and her consulting group, Anchor.

0:03:58: Discussion on the impact of decisions in quality assurance and risk-based approaches.

0:08:12: Conversation about the proactive and preventative approach in quality management.

0:15:33: Highlighting the importance of collaboration and communication in quality culture.

0:18:39: Emphasizing the ultimate target in quality management, which is the patient.

0:19:48: Discussion on the need for processes and controls in quality management.

0:21:07: Conversation about the value of audits and opportunities for improvement.

0:23:54: Acknowledgment of the importance of a collaborative and non-confrontational approach in quality management.

0:27:10: Closing remarks and contact information for the podcast.

Love the show? Subscribe, Rate, Review, Like, and Share!

Let’s Connect!

From Bench to Bedside: Navigating Failures and Triumphs in Pharma and Biotech

Saison 2 · Épisode 4

mardi 12 septembre 2023 • Durée 31:53

In 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 the conversation.

Tune in!

During this episode, you will learn about;

0:00:32 The Queens of Quality discuss the topic of failure

0:02:05 From Bench to Bedside: Pharma Industry's Journey

0:05:14 The Challenge of Identifying the Right Target

0:07:57 Ensuring Support and Documentation for Clinical Phases

0:10:10 Phase One Trials: High Failure Rate and Cost Implications

0:12:05 Multiple Development Paths and the Importance of Phase Two

0:14:22 Phase Three Trials: Expanding Patient Population and Clinical Programs

0:15:52 The Final Stretch: Phase Three Programs

0:16:19 The Reality: Fast-paced and Not Funny

0:18:23 Long Timelines and Challenges in Clinical Trials

0:20:35 Study Drug Adherence: A Critical Factor in Audits

0:21:15 High Adherence Rate in Children's Oncology Study

0:23:25 The Importance of Reinvestment and Balancing Product Pipeline

0:25:31 Collaboration between academia and industry in pharmaceutical innovation

0:28:02 Progress and success in the pharma and biotech industry

Leadership Support and Inspection Readiness: Ensuring Organizational Excellence

Saison 2 · Épisode 3

mardi 29 août 2023 • Durée 32:40

Leadership Support and Inspection Readiness: Ensuring Organizational Excellence

In 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.

Tune in!

During this episode, you will learn about;

[00:00:32] Introduction: Michelleanne and Jenn discuss the crucial role of leadership support in effective organizations.

[00:02:28] Leadership's impact on departmental efficiency, adherence to guidelines, and overall effectiveness.

[00:08:57] Emphasis on creating a safe environment for team members to share challenges, even during personal difficulties.

[00:13:07] Exploring the connection between leadership actions, communication, and team members' sense of security.

[00:15:27] Jenn's experience adapting leadership discussions to resonate with different perspectives.

[00:19:41] Michelleanne's encounters with frequent inspections and understanding the "why" behind operations.

[00:25:56] The hosts emphasize the mission-critical nature of leadership support in maintaining organizational excellence.

[00:29:34]: Call to action and closing remarks

A Comprehensive Guide to Audits and Compliance in Pharmaceuticals

Saison 2 · Épisode 2

mardi 15 août 2023 • Durée 37:49

This 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 in vendor management and how to balance regional requirements in the qualification process. This episode is an enlightening and exciting rollercoaster ride into the world of pharmaceutical vendor management.

Tune in!

During this episode, you will learn about the following;

0:00:31 - Start of the show and Introduction of Hosts

0:02:14 - Qualification and Requalification Process Discussion

0:08:32 - Misconceptions About Vendor Qualification

0:19:04 - Document Access and Audit Scheduling Issues

0:24:16 - The Importance of Quality in Business

0:30:07 - Harmonizing Global and Local Operations

0:33:29 - Assessing Data Entry Accuracy and Guidelines

0:36:08 - Hosts' final thoughts and sign-off

Love the show? Subscribe, Rate, Review, Like, and Share!

Let’s Connect!

Website: https://metisconsultingservices.com/

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Queens of Quality Podcast – Détails, épisodes et analyse

Détails du podcast

Classements récents

Apple Podcasts

Spotify

Liens partagés entre épisodes et podcasts

LinkedIn5

Other2

Qualité et score du flux RSS

Historique des publications

Derniers épisodes publiés

Podcasts et contenus similaires

Podcasts Similaires Basées sur le Contenu

Apple Podcasts

Spotify

Podcasts Similaires Basées sur le Contenu

LinkedIn5

Other2