Queens of Quality Podcast

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 challe...

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

This week joined by Nicole Latimer, CEO of Medrio. What do we see as we look to the future.

What do we need to ensure data integrity? How do we get there? What are some pieces we can avoid along the way?

Michelleanne and Katrina and Data Management and Quality!

Matt Bodo and Michelleanne discuss how we have yet to move the needle and why.

Queens of Quality Returns for Season 3! My first guest is Dr Lucia Mokres of Araneae Consulting. Welcome!

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 l...

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 avoid...

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 importan...

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, Ste...

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...

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...

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 lead...

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 t...

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...

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, team...

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 qual...

Ever 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...

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 Pharmacovi...

Pharmacovigilance 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 safet...

Adopting 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 episod...

Welcome 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 regu...

The 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. W...

The 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 episod...