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.
Listen to episodes
26 recent
July 28, 202522 min
Quality: Scopes, Approaches, and Oversights
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.
July 8, 202542 min
Wish lists and action items
Forest Flodin and Michelleanne talk about how we wish projects could go, and what some of the stumbling blocks are along the way.
June 30, 202525 min
Data Management looks to the future
This week joined by Nicole Latimer, CEO of Medrio. What do we see as we look to the future.
June 23, 202534 min
The path to Data Integrity
What do we need to ensure data integrity? How do we get there? What are some pieces we can avoid along the way?
June 16, 202535 min
The importance of DM
Michelleanne and Katrina and Data Management and Quality!
June 9, 202533 min
Same approach will always provide the same outcome.
Matt Bodo and Michelleanne discuss how we have yet to move the needle and why.
June 2, 202528 min
Fixers and Bio-Business, with Lucia Mokres
Queens of Quality Returns for Season 3! My first guest is Dr Lucia Mokres of Araneae Consulting. Welcome!
February 20, 202427 min
Unlocking Ethical AI in Life Sciences: Insights with Steve Thompson PT4
In 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 considerations. Lastly, it expands on the ARB's potential in handling AI's limitations from different perspectives, confirming their readiness to tackle new challenges and inviting more diverse voices to join the conversation. 00:31 Introduction and Welcome 00:54 Discussion on AI and Ethics 01:48 Understanding Negative Programming in AI 02:12 Exploring AI's Limitations: Pattern Matching and Negation 04:27 AI's Struggle with 'No' and 'Not' 07:33 AI's Lack of Self-Awareness and Empathy 09:06 The Role of AI as a Tool, Not a Replacement 10:16 The Importance of Human Involvement in AI 11:00 AI's Struggle with Uncertainty 14:10 The Role of the Algorithm Review Board (ARB) 22:32 Conclusion and Invitation for Participation 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 Emily Barker Linked In: https://www.linkedin.com/in/mannbark/ Connect with Queens of Quality; Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: hello@metisconsultingservices.com
January 30, 202427 min
Unlocking Ethical AI in Life Sciences: Insights with Steve Thompson and Emily Barker PT3
In 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 highlighted the significance of creating an AI lexicon to ensure all industry players speak the same language and invited community participation. 00:31 Introduction and Guest Introduction 01:25 Discussing AI Ethics and Algorithm Review Board 02:51 Understanding the Complexity of AI Landscape 03:56 The Importance of Language Consistency in AI 04:47 Exploring the Concept of Algorithm Review Board 06:10 The Challenges of Reproducing AI Results 07:44 Understanding the Algorithm in AI 10:47 The Role of Algorithm Review Board in AI 12:21 The Importance of Involving Diverse Perspectives in AI 13:01 The Future of AI in Life Sciences 23:02 The Need for Pre-Work in AI 26:48 Conclusion and Call to Action 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 Emily Barker Linked In: https://www.linkedin.com/in/mannbark/ Connect with Queens of Quality; Website: https://metisconsultingservices.com/ LinkedIn: https://www.linkedin.com/company/metis-consulting-services/ Email: hello@metisconsultingservices.com
January 9, 202426 min
Unlocking Ethical AI in Life Sciences: Insights with Steve Thompson PT2
In 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 Back 00:40 Discussion on AI and Clinical Trials 01:17 The Concept of Algorithm Review Board 01:44 The Evolution and Impact of Technology 02:35 The Synthetic Patient Concept 04:10 The Need for Ethical Standards in AI 05:42 The Role of Institutional Review Boards 08:49 The Importance of Diverse Representation 10:48 The Idea of Algorithm Review Board 10:59 The Need for Collaboration and Inclusion 12:15 The Risks of Misusing AI in Medicine 20:26 The Importance of Preventative Measures 21:12 Call to Action for Audience Participation 24:30 Conclusion and Invitation for Future Discussions 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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