https://simplecast.com Queens of Quality Podcast 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. 2022 - Queen of Quality Podcast en Mon, 28 Jul 2025 07:00:00 +0000 Mon, 28 Jul 2025 18:35:16 +0000 https://queens-of-quality-podcast.simplecast.com Queens of Quality Podcast https://image.simplecastcdn.com/images/8946ecd0-8abb-4963-a001-db132def1ebd/fe531447-6048-4958-8462-9409c873d39c/3000x3000/untitled-design-10.jpg?aid=rss_feed https://queens-of-quality-podcast.simplecast.com episodic 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. Michelleanne Bradley false https://feeds.simplecast.com/JtXdvoM0 biotech, biotechnology, pharma organizations, quality and compliance, quality assurance Michelleanne Bradley mlbradley@metisconsultingservices.com d56a65ac-cbfa-4698-b240-b8f492c9cb81 Quality: Scopes, Approaches, and Oversights Mon, 28 Jul 2025 07:00:00 +0000 mlbradley@metisconsultingservices.com (Kara Harrison) https://queens-of-quality-podcast.simplecast.com/episodes/quality-scopes-approaches-and-oversights-EJcWfsVu Quality: Scopes, Approaches, and Oversights Kara Harrison 00:22:31 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. 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. biotech, pharmaceutical industry, quality assurance false full 7 3 e89e750e-62d7-4b81-b8c0-541b133a61ae Wish lists and action items Tue, 8 Jul 2025 07:00:00 +0000 mlbradley@metisconsultingservices.com (Forest Flodin) https://queens-of-quality-podcast.simplecast.com/episodes/wish-lists-and-action-items-7Hg_uJa7 Wish lists and action items Forest Flodin 00:42:25 Forest Flodin and Michelleanne talk about how we wish projects could go, and what some of the stumbling blocks are along the way. Forest Flodin and Michelleanne talk about how we wish projects could go, and what some of the stumbling blocks are along the way. false full 6 3 fd028823-e5ea-4b78-8595-ead4623f1a2a Data Management looks to the future Mon, 30 Jun 2025 07:00:00 +0000 mlbradley@metisconsultingservices.com (Nicole Latimer) https://queens-of-quality-podcast.simplecast.com/episodes/data-management-looks-to-the-future-A3ENDXVD Data Management looks to the future Nicole Latimer 00:25:33 This week joined by Nicole Latimer, CEO of Medrio. What do we see as we look to the future. This week joined by Nicole Latimer, CEO of Medrio. What do we see as we look to the future. false full 5 3 3b966df5-5151-44de-8cfe-f7f1b35dbff7 The path to Data Integrity Mon, 23 Jun 2025 07:00:00 +0000 mlbradley@metisconsultingservices.com (Shane DeBuchel) https://queens-of-quality-podcast.simplecast.com/episodes/the-path-to-data-integrity-HofncMMW The path to Data Integrity Shane DeBuchel 00:34:31 What do we need to ensure data integrity? How do we get there? What are some pieces we can avoid along the way? What do we need to ensure data integrity? How do we get there? What are some pieces we can avoid along the way? false full 4 3 6f170e68-a67d-4c69-9a0f-085c6300f8c1 The importance of DM Mon, 16 Jun 2025 07:00:00 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley) https://queens-of-quality-podcast.simplecast.com/episodes/the-importance-of-dm-SWewUFZN The importance of DM Michelleanne Bradley 00:35:53 Michelleanne and Katrina and Data Management and Quality! Michelleanne and Katrina and Data Management and Quality! false full 3 3 8cfad79b-b09d-48ed-a35a-94dba6214ad2 Same approach will always provide the same outcome. Mon, 9 Jun 2025 07:00:00 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley) https://queens-of-quality-podcast.simplecast.com/episodes/same-approach-will-always-provide-the-same-outcome-u4ajpZKB Same approach will always provide the same outcome. Michelleanne Bradley 00:33:57 Matt Bodo and Michelleanne discuss how we have yet to move the needle and why. Matt Bodo and Michelleanne discuss how we have yet to move the needle and why. false full 2 3 2d7ed767-9bf7-4c74-804f-014a5cdb1c4f Fixers and Bio-Business, with Lucia Mokres Mon, 2 Jun 2025 07:00:00 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley) https://queens-of-quality-podcast.simplecast.com/episodes/fixers-and-bio-business-with-lucia-mokres-g_tJN8JW Fixers and Bio-Business, with Lucia Mokres Michelleanne Bradley 00:28:01 Queens of Quality Returns for Season 3! My first guest is Dr Lucia Mokres of Araneae Consulting. Welcome! Queens of Quality Returns for Season 3! My first guest is Dr Lucia Mokres of Araneae Consulting. Welcome! false full 1 3 ae33310d-9007-4142-8c54-882e28efc287 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

 

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]]> Tue, 20 Feb 2024 08:00:00 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley, Emily Barker, Steven Thompson, Jennifer DiMarco) https://queens-of-quality-podcast.simplecast.com/episodes/unlocking-ethical-ai-in-life-sciences-insights-with-steve-thompson-pt4-khXDKZOj 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

 

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Connect with Steve Thompson

Connect with Emily Barker

Connect with Queens of Quality;

]]> Unlocking Ethical AI in Life Sciences: Insights with Steve Thompson PT4 Michelleanne Bradley, Emily Barker, Steven Thompson, Jennifer DiMarco 00:27:28 ai in healthcare, algorithm review board, pharma, life sciences, ai ethics, technology ethics, human behavior, medical technology, biotech, ai, ethical ai, negative programming in ai, ethics false bonus 2 2c0019bd-5655-4b11-a5ea-edfb6eb525dc 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

 

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Connect with Steve Thompson

Connect with Emily Barker

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]]> Tue, 30 Jan 2024 08:00:00 +0000 mlbradley@metisconsultingservices.com (Emily Barker, Jennifer DiMarco, Michelleanne Bradley, Steven Thompson) https://queens-of-quality-podcast.simplecast.com/episodes/unlocking-ethical-ai-in-life-sciences-insights-with-steve-thompson-and-emily-barker-pt3-UngUqBRf 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

 

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Connect with Steve Thompson

Connect with Emily Barker

Connect with Queens of Quality;

]]> Unlocking Ethical AI in Life Sciences: Insights with Steve Thompson and Emily Barker PT3 Emily Barker, Jennifer DiMarco, Michelleanne Bradley, Steven Thompson 00:27:54 biopharma, algorithm review board, clinical trials, ai ethics, artificial intelligence false bonus 2 afac2f43-02a4-4989-b55a-93186cd59b66 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

 

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Connect with Steve Thompson

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]]> Tue, 9 Jan 2024 08:00:00 +0000 mlbradley@metisconsultingservices.com (Jennifer DiMarco, Steven Thompson, Michelleanne Bradley) https://queens-of-quality-podcast.simplecast.com/episodes/unlocking-ethical-ai-in-life-sciences-insights-with-steve-thompson-pt2-PBP015mC 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

 

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Let’s Connect!

Connect with Steve Thompson

Connect with Queens of Quality;

]]> Unlocking Ethical AI in Life Sciences: Insights with Steve Thompson PT2 Jennifer DiMarco, Steven Thompson, Michelleanne Bradley 00:26:09 risk management, regulatory affairs, life sciences, data integrity, technology ethics, pharmacovigilance, ai applications, ethical ai, bias in ai, healthcare innovation, multidisciplinary approach false bonus 2 873cf40b-518a-48d2-ab88-19c776715bd8 Unlocking Ethical AI in Life Sciences: Insights with Steve Thompson 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     

 

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Connect with Steve Thompson

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Email: 

]]> Tue, 19 Dec 2023 08:00:00 +0000 mlbradley@metisconsultingservices.com (Steven Thompson, Jennifer DiMarco, Michelleanne Bradley) https://queens-of-quality-podcast.simplecast.com/episodes/unlocking-ethical-ai-in-life-sciences-insights-with-steve-thompson-rV6tN3it 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     

 

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Let’s Connect!

 

Connect with Steve Thompson

Connect with Queens of Quality;

Email: 

]]> Unlocking Ethical AI in Life Sciences: Insights with Steve Thompson Steven Thompson, Jennifer DiMarco, Michelleanne Bradley 00:30:53 risk management, future technology, regulatory affairs, life sciences, data integrity, technology ethics, pharmacovigilance, ai applications, technological advancement, ethical ai, podcast discussion, bias in ai, healthcare innovation, multidisciplinary approach false bonus 2 95adc445-431b-4375-beca-625469086584 Embracing Evolution and Growth in Quality 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

 

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Connect with Queens of Quality;

 

]]> Tue, 21 Nov 2023 08:00:00 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley, Jennifer DiMarco) https://queens-of-quality-podcast.simplecast.com/episodes/embracing-evolution-and-growth-in-quality-8easJg1H 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

 

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Let’s Connect!

 

Connect with Queens of Quality;

 

]]> Embracing Evolution and Growth in Quality Michelleanne Bradley, Jennifer DiMarco 00:16:20 soft skills, inspection readiness, regulatory changes, compliance, industry impact, simplification, evolution, pharmaceutical industry, growth, quality, learning from failure, reflections false full 8 2 10797c08-ef4e-4b5c-99ef-6d7f0e785dc2 A Journey through the Pharmaceutical Regulation and Quality Design 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

            

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]]> Tue, 24 Oct 2023 07:00:00 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley, Jennifer DiMarco) https://queens-of-quality-podcast.simplecast.com/episodes/a-journey-through-the-pharmaceutical-regulation-and-quality-design-ZkPoQjsq 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

            

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]]> A Journey through the Pharmaceutical Regulation and Quality Design Michelleanne Bradley, Jennifer DiMarco 00:23:50 ich, globalimpact, regulatorychanges, clinicaltrials, complementaryguidance, ichrevisions, queensofquality, qualitybydesign, pharmaceuticalindustry, operationalfeasibility, technologyevolution false full 7 2 4cf0b218-7d0b-4912-b221-660fbb31c389 Revolutionizing the REMS Industry with Sherice Mills 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.

            

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Connect with Sherice Mills;

Connect with Queens of Quality;

]]> Tue, 10 Oct 2023 07:00:00 +0000 mlbradley@metisconsultingservices.com (Sherice Mills, Jennifer DiMarco, Michelleanne Bradley) https://queens-of-quality-podcast.simplecast.com/episodes/revolutionizing-the-rems-industry-with-sherice-mills-vEFHpQDS 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.

            

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Connect with Sherice Mills;

Connect with Queens of Quality;

]]> Revolutionizing the REMS Industry with Sherice Mills Sherice Mills, Jennifer DiMarco, Michelleanne Bradley 00:32:30 innovation, rems, healthcare industry, risk management, consulting, ai in healthcare, medical innovation., thought leadership, compliance, regulatory compliance, pharmaceuticals, medical technology, biotech, patient safety, fda, quality assurance false full 6 2 c99b1111-a893-4f37-8e0d-8164047358a5 The Evolution of Compliance in Biotech and Pharma with Cheryl McCarthy 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.

            

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Let’s Connect!

 

Connect with Cheryl McCarthy;

Connect with Queens of Quality;


 

]]> Tue, 26 Sep 2023 07:00:00 +0000 mlbradley@metisconsultingservices.com (Cheryl McCarthy, Jennifer DiMarco, Michelleanne Bradley) https://queens-of-quality-podcast.simplecast.com/episodes/the-evolution-of-compliance-in-biotech-and-pharma-with-cheryl-mccarthy-CFAU6rfI 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!

 

Connect with Cheryl McCarthy;

Connect with Queens of Quality;


 

]]> The Evolution of Compliance in Biotech and Pharma with Cheryl McCarthy Cheryl McCarthy, Jennifer DiMarco, Michelleanne Bradley 00:28:18 audits, communication, pharma, compliance, ichu6r3 guidance, quality control, biotech, collaboration., quality, software space, regulatory approach, decision-making, quality management, agile methodology false full 5 2 a441e876-715e-43eb-9c70-ea0177e20595 From Bench to Bedside: Navigating Failures and Triumphs in Pharma and Biotech 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

0:31:16 Wrapping up the Queens of Quality Podcast

            

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

Let’s Connect!

]]> Tue, 12 Sep 2023 07:00:00 +0000 mlbradley@metisconsultingservices.com (Jennifer DiMarco, Michelleanne Bradley) https://queens-of-quality-podcast.simplecast.com/episodes/from-bench-to-bedside-navigating-failures-and-triumphs-in-pharma-and-biotech-_yQuhYod 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

0:31:16 Wrapping up the Queens of Quality 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 Jennifer DiMarco, Michelleanne Bradley 00:31:53 drug development process, academia and industry, phase three trials, drug development challenges, clinical testing, collaboration, progress in pharma and biotech, phase one trials, phase two development, timelines in clinical trials, queens of quality, metis consulting services, failure in drug development, biotech industry, clinical program, pharmaceutical industry, drug adherence, pharmaceutical innovation, product pipeline false full 4 2 45aa8498-23d7-4f04-a6b1-0246a55b7831 Leadership Support and Inspection Readiness: Ensuring Organizational Excellence 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

            

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

Let’s Connect!

]]> Tue, 29 Aug 2023 07:00:00 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley, Jennifer DiMarco) https://queens-of-quality-podcast.simplecast.com/episodes/leadership-support-and-inspection-readiness-ensuring-organizational-excellence-9471TYZ5 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

            

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

Let’s Connect!

]]> Leadership Support and Inspection Readiness: Ensuring Organizational Excellence Michelleanne Bradley, Jennifer DiMarco 00:32:40 organizational excellence, management role, leadership support, teamwork, effective organizations, team collaboration, open communication false full 3 2 37054477-2b58-4dc9-a36d-64b9b2b64aba A Comprehensive Guide to Audits and Compliance in Pharmaceuticals 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!

]]> Tue, 15 Aug 2023 07:00:00 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley, Jennifer DiMarco) https://queens-of-quality-podcast.simplecast.com/episodes/a-comprehensive-guide-to-audits-and-compliance-in-pharmaceuticals-WWCkvF_V 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!

]]> A Comprehensive Guide to Audits and Compliance in Pharmaceuticals Michelleanne Bradley, Jennifer DiMarco 00:37:49 vendor management, collaboration, supply chain, business needs, supplier assessment, regulatory requirements, vendor qualification, risk assessment, qualification process, vendor partnership, quality standards, quality assurance false full 2 2 2db25394-3b7d-40db-8801-d0f79cd7f44d Cultivating a Quality Culture in Pharma and Biotech 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 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.

 

Did you know the importance of humor in maintaining your sanity amidst the daily grind of hard work? We couldn't agree more! Balancing the seriousness of the work with our mental well-being is an art that needs mastering. Tune in as we discuss the art of decision-making, demonstrating our work outcomes, and proactively mitigating risks using a Risk Evaluation and Mitigation Strategy (REMS). As we delve deeper into this conversation, we also touch upon the importance of evaluating potential employers and the significance of quality control in preserving your future. Join us for insights, laughter, and shared experiences on this journey toward cultivating a culture of quality.

Tune in!

 

During this episode, you will learn about;

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

(0:01:00) - Overview of Season Two Topics

(0:03:00) - Discussion on Culture of Quality

(0:11:24) - The Role of Humor in the Workplace

(0:16:27) - The Importance of Conservative Decision-Making and REMS

(0:21:57) - The Art of Interviewing Potential Employers

(0:27:03) - Maintaining Quality Control and Safeguarding Future

 

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

 

Let’s Connect!

]]> Tue, 1 Aug 2023 07:00:00 +0000 mlbradley@metisconsultingservices.com (Jennifer DiMarco, Michelleanne Bradley) https://queens-of-quality-podcast.simplecast.com/episodes/cultivating-a-quality-culture-in-pharma-and-biotech-CRDmGCxe 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 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.

 

Did you know the importance of humor in maintaining your sanity amidst the daily grind of hard work? We couldn't agree more! Balancing the seriousness of the work with our mental well-being is an art that needs mastering. Tune in as we discuss the art of decision-making, demonstrating our work outcomes, and proactively mitigating risks using a Risk Evaluation and Mitigation Strategy (REMS). As we delve deeper into this conversation, we also touch upon the importance of evaluating potential employers and the significance of quality control in preserving your future. Join us for insights, laughter, and shared experiences on this journey toward cultivating a culture of quality.

Tune in!

 

During this episode, you will learn about;

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

(0:01:00) - Overview of Season Two Topics

(0:03:00) - Discussion on Culture of Quality

(0:11:24) - The Role of Humor in the Workplace

(0:16:27) - The Importance of Conservative Decision-Making and REMS

(0:21:57) - The Art of Interviewing Potential Employers

(0:27:03) - Maintaining Quality Control and Safeguarding Future

 

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

 

Let’s Connect!

]]> Cultivating a Quality Culture in Pharma and Biotech Jennifer DiMarco, Michelleanne Bradley 00:30:22 risk evaluation and mitigation strategy, pharmaceuticals industry, compliance, job interview, mental well-being, quality control, pharmaceuticals, biotech industry., robust communication, biotech, quality centric environment, group dynamics, leadership skills, quality culture, group thinking false full 1 2 6b30d58c-3d83-4328-b27a-9a4a3c20980e Risk 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 introduction

[00:37] Today’s theme; Risk Evaluation and Mitigation Strategy (REMS) 

[01:18] When was REMS started?

[01:44] The history of Thalidomide and why REMS closely monitors it

[07:03] Single REMS vs Shared REMS 

[11:20] Risk piece in REMS program 

[12:21] Evaluation piece in REMS program 

[17:35] The difference between Pharmacovigilance (PV) and REMS

[18:35] Mitigation piece in REMS program 

[21:44] The REMS Industry Consortium (RIC) 

[25:28] How to get started with a REMS program

[26:55] What to expect in the next episode

[27:41] How to connect with us 

 

Remember to Subscribe, Rate, Review, Like, and Share!

Let’s Connect!

]]> Wed, 7 Sep 2022 13:51:33 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley, Jennifer DiMarco) https://queens-of-quality-podcast.simplecast.com/episodes/risk-evaluation-and-mitigation-strategy-rems-qgrBuWcL 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 introduction

[00:37] Today’s theme; Risk Evaluation and Mitigation Strategy (REMS) 

[01:18] When was REMS started?

[01:44] The history of Thalidomide and why REMS closely monitors it

[07:03] Single REMS vs Shared REMS 

[11:20] Risk piece in REMS program 

[12:21] Evaluation piece in REMS program 

[17:35] The difference between Pharmacovigilance (PV) and REMS

[18:35] Mitigation piece in REMS program 

[21:44] The REMS Industry Consortium (RIC) 

[25:28] How to get started with a REMS program

[26:55] What to expect in the next episode

[27:41] How to connect with us 

 

Remember to Subscribe, Rate, Review, Like, and Share!

Let’s Connect!

]]> Risk Evaluation and Mitigation Strategy (REMS) Michelleanne Bradley, Jennifer DiMarco 00:28:26 rems, thalidomide, pharma, rems industry consortium, mitigation strategy, biotech, risk evaluation false full 6 1 b61ee436-d108-4d5d-b8a5-62ef6928042f Pharmacovigilance 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 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.

 

Tune in!

 

During this episode, you will learn about;

[00:01] Episode introduction

[00:35] Today’s focus; pharmacovigilance 

[01:23] Definition of pharmacovigilance

[04:20] Who is responsible for drug safety & pharmacovigilance?

[05:54] Sources of pharmacovigilance data

[08:40] Pharmacovigilance in clinical trials 

[10:00] Adverse Event (AE) reporting policy

[14:33] Investigator’s Brochure (IB)

[16:30] Postmarketing surveillance and adverse drug reactions

[20:03] A recap of the episode

[22:21] Turning pharmacovigilance into a competitive advantage

[26:04] How to connect with us

 

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

 

Let’s Connect!

]]> Wed, 24 Aug 2022 12:00:00 +0000 mlbradley@metisconsultingservices.com (Jennifer DiMarco) https://queens-of-quality-podcast.simplecast.com/episodes/pharmacovigilance-_5elIzu9 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 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.

 

Tune in!

 

During this episode, you will learn about;

[00:01] Episode introduction

[00:35] Today’s focus; pharmacovigilance 

[01:23] Definition of pharmacovigilance

[04:20] Who is responsible for drug safety & pharmacovigilance?

[05:54] Sources of pharmacovigilance data

[08:40] Pharmacovigilance in clinical trials 

[10:00] Adverse Event (AE) reporting policy

[14:33] Investigator’s Brochure (IB)

[16:30] Postmarketing surveillance and adverse drug reactions

[20:03] A recap of the episode

[22:21] Turning pharmacovigilance into a competitive advantage

[26:04] How to connect with us

 

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

 

Let’s Connect!

]]> Pharmacovigilance Jennifer DiMarco 00:26:47 pharmaceutical, drug safety, clinical trials, pharmacovigilance, biotech false full 5 1 90dc8d7a-0c63-4fb1-8eea-74a7dbd7fcfb Adopting A Proactive Approach to Quality and Compliance 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 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 the workplace. Moreover, we share the difference between a mistake and something being wrong.

Tune in!

During this episode, you will learn about;

[00:01] Introduction to the show

[00:37] Today’s theme; Taking a proactive approach

[04:53] What’s Michelleanne’s biggest learning from COVID-19 as quality & compliance professional?

[07:49] Jennifer’s biggest learning from COVID-19 as quality & compliance professional

[11:41] Mistakes that have been made when handling the pandemic

[14:26] Acknowledging workplace mistakes

[16:28] Forgiveness in the workplace

[17:27] Learning from the mistakes we make

[21:40] The difference between a mistake and something being wrong

[22:45] How to connect with us

 

  Don’t forget to Follow, Rate, Review, Like, and Share!

 

Let’s Connect!

Email: info@metisconsultingservices.com

]]> Wed, 10 Aug 2022 12:00:00 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley, Jennifer DiMarco) https://queens-of-quality-podcast.simplecast.com/episodes/adopting-a-proactive-approach-to-quality-and-compliance-s2o3_AoG 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 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 the workplace. Moreover, we share the difference between a mistake and something being wrong.

Tune in!

During this episode, you will learn about;

[00:01] Introduction to the show

[00:37] Today’s theme; Taking a proactive approach

[04:53] What’s Michelleanne’s biggest learning from COVID-19 as quality & compliance professional?

[07:49] Jennifer’s biggest learning from COVID-19 as quality & compliance professional

[11:41] Mistakes that have been made when handling the pandemic

[14:26] Acknowledging workplace mistakes

[16:28] Forgiveness in the workplace

[17:27] Learning from the mistakes we make

[21:40] The difference between a mistake and something being wrong

[22:45] How to connect with us

 

  Don’t forget to Follow, Rate, Review, Like, and Share!

 

Let’s Connect!

Email: info@metisconsultingservices.com

]]> Adopting A Proactive Approach to Quality and Compliance Michelleanne Bradley, Jennifer DiMarco 00:23:27 competition, pharma, competitive advantage, proactive, quality and complians, biotechnology, covid-19 false full 4 1 5bba2a8e-7dce-4951-8a35-df77e5814034 The Regulatory Landscape 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 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.

 

Tune in!

 

During this episode, you will learn about;

[00:01] Episode introduction

[00:35] Today’s focus; Regulatory landscape

[02:21] What we took for granted pre- COVID-19

[04:10] Changes that have taken place in the regulatory process since the development of the polio vaccine

[08:39] What is the role of the regulatory organization

[12:39] Quality vs. Regulatory

[13:56] Why leveraging your regulatory department is important

[16:00] European Medicines Agency (EMA) regulatory guidelines

[18:22] Precision medicine (personalized medicine)

[23:13] Does firm size affect regulatory requirements?

[25:07] Ensuring that people have solutions that are fit for purpose

[33:26] A recap of the episode

[35:45] How to connect with us

 

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

 

Let’s Connect!

● Website: https://metisconsultingservices.com/

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

● Email: info@metisconsultingservices.com

]]> Wed, 27 Jul 2022 12:00:00 +0000 mlbradley@metisconsultingservices.com (Jennifer DiMarco, Michelleanne Bradley) https://queens-of-quality-podcast.simplecast.com/episodes/the-regulatory-landscape-LKby3Nwp 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 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.

 

Tune in!

 

During this episode, you will learn about;

[00:01] Episode introduction

[00:35] Today’s focus; Regulatory landscape

[02:21] What we took for granted pre- COVID-19

[04:10] Changes that have taken place in the regulatory process since the development of the polio vaccine

[08:39] What is the role of the regulatory organization

[12:39] Quality vs. Regulatory

[13:56] Why leveraging your regulatory department is important

[16:00] European Medicines Agency (EMA) regulatory guidelines

[18:22] Precision medicine (personalized medicine)

[23:13] Does firm size affect regulatory requirements?

[25:07] Ensuring that people have solutions that are fit for purpose

[33:26] A recap of the episode

[35:45] How to connect with us

 

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

 

Let’s Connect!

● Website: https://metisconsultingservices.com/

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● Email: info@metisconsultingservices.com

]]> The Regulatory Landscape Jennifer DiMarco, Michelleanne Bradley 00:36:13 regulatory, quality control, pharmaceutical industry, regulatory landscape, regulatory process false full 3 1 1583014b-2ce2-4640-99cd-0f23227da846 The Ultimate Guide to Audit and Inspection Readiness 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.

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, and people’s perception of inspectors & auditors. Additionally, we talk about the importance of having an audit plan or program, new trends in auditing & inspection, and the most effective way of performing an audit of your vendors.

 

Tune in!

 

During this episode, you will learn about;

[00:02] Introduction to the show

[00:33] What’s in for you in today’s episode

[01:05] The importance of inspections and audits

[03:34] Identifying the right people to be in front of an inspector 

[05:38] People’s perception of inspectors and auditors

[09:54] Importance of having an audit plan or program

[11:28] Why an external audit is important

[17:19] New trends in auditing and inspection 

[20:02] Things you should not say in an audit interview

[23:16] How do you perform an audit of your vendors?

[24:49] Risk vs non-compliances

[28:02] How to connect with us

 

Don’t forget to Subscribe, Rate, Review, Like, and Share!

 

Let’s Connect!

]]> Thu, 14 Jul 2022 15:05:52 +0000 mlbradley@metisconsultingservices.com (Metis Consulting Services, Michelleanne Bradley, Jennifer DiMarco) https://queens-of-quality-podcast.simplecast.com/episodes/the-ultimate-guide-to-audit-and-inspection-readiness-Q61blP2r 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.

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, and people’s perception of inspectors & auditors. Additionally, we talk about the importance of having an audit plan or program, new trends in auditing & inspection, and the most effective way of performing an audit of your vendors.

 

Tune in!

 

During this episode, you will learn about;

[00:02] Introduction to the show

[00:33] What’s in for you in today’s episode

[01:05] The importance of inspections and audits

[03:34] Identifying the right people to be in front of an inspector 

[05:38] People’s perception of inspectors and auditors

[09:54] Importance of having an audit plan or program

[11:28] Why an external audit is important

[17:19] New trends in auditing and inspection 

[20:02] Things you should not say in an audit interview

[23:16] How do you perform an audit of your vendors?

[24:49] Risk vs non-compliances

[28:02] How to connect with us

 

Don’t forget to Subscribe, Rate, Review, Like, and Share!

 

Let’s Connect!

]]> The Ultimate Guide to Audit and Inspection Readiness Metis Consulting Services, Michelleanne Bradley, Jennifer DiMarco 00:28:26 audits, non-compliances, inspector, risk, inspection false full 2 1 8d211b7d-a0b0-4ed2-9efb-a79f9ee562ee Quality and Compliance in The Pharmaceutical Industry 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 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 are important in the pharmaceutical industry.

Tune in!

 

During this episode, you will learn about;

[00:01] Episode introduction

[00:41] Know your hosts; Jennifer DiMarco’s bio

[01:31] Michelleanne Bradley’s bio

[02:39] Why we created the ‘Queens of Quality’ podcast

[04:00] Michelleanne’s perspective on the difference between compliance and quality

[04:14] Jennifer’s perspective on the difference between compliance and quality

[07:31] Quality and compliance framework

[12:54] The importance of effective communication within an organization

[18:28] Why compliance and quality are important in the pharmaceutical industry

[22:12] What to expect in our next episode

[23:01] How to connect with us

 

Don’t forget to Subscribe, Rate, Review, Like, and Share!

 

Let’s Connect!

]]> Wed, 29 Jun 2022 20:43:55 +0000 mlbradley@metisconsultingservices.com (Jennifer DiMarco, Michelleanne Bradley, Metis Consulting Services) https://queens-of-quality-podcast.simplecast.com/episodes/quality-and-compliance-in-the-pharmaceutical-industry-wi_W3D_E 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 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 are important in the pharmaceutical industry.

Tune in!

 

During this episode, you will learn about;

[00:01] Episode introduction

[00:41] Know your hosts; Jennifer DiMarco’s bio

[01:31] Michelleanne Bradley’s bio

[02:39] Why we created the ‘Queens of Quality’ podcast

[04:00] Michelleanne’s perspective on the difference between compliance and quality

[04:14] Jennifer’s perspective on the difference between compliance and quality

[07:31] Quality and compliance framework

[12:54] The importance of effective communication within an organization

[18:28] Why compliance and quality are important in the pharmaceutical industry

[22:12] What to expect in our next episode

[23:01] How to connect with us

 

Don’t forget to Subscribe, Rate, Review, Like, and Share!

 

Let’s Connect!

]]> Quality and Compliance in The Pharmaceutical Industry Jennifer DiMarco, Michelleanne Bradley, Metis Consulting Services 00:23:25 communication, compliance, pharmaceutical industry, perspective, quality false full 1 1 3126c8af-7dc3-446b-b063-1b805e1c8d12 Welcome to Queens of Quality Podcast Welcome 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!

 

Let’s Connect!

]]> Tue, 28 Jun 2022 04:04:56 +0000 mlbradley@metisconsultingservices.com (Michelleanne Bradley, Jennifer DiMarco, Metis Consulting Services) https://queens-of-quality-podcast.simplecast.com/episodes/welcome-to-queens-of-quality-podcast-I7X9LPAD Welcome 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!

 

Let’s Connect!

]]> Welcome to Queens of Quality Podcast Michelleanne Bradley, Jennifer DiMarco, Metis Consulting Services 00:01:06 innovation, pharmaceutical, regulations, strategies, biotech, solutions false trailer 1