The Intersection of Theory and Practice in Quality Management: Perspectives from Amy Wilson and Cliff Berry

06/15/23 • 34 min

Episode 018: Harsh Thakkar (@harshvthakkar) interviews Amy Wilson (@amydwilson) and Cliff Berry (@cliffordberry), co-authors of the book Do Quality Differently, a playbook for creating more success in biopharma (or any) manufacturing.

Amy Wilson and Cliff Berry explore the concepts of the black line and blue line, underscoring the importance of distinguishing between them. They highlight the need to take a comprehensive view of the system, rather than solely focusing on human error.
Harsh, Amy, and Cliff stress the importance of building fluency in the vocabulary and concepts of human and organizational performance in order to enable the adoption of new practices and processes within an organization. The podcast also touches on practical examples from their careers and the challenges of writing their book, Do Quality Differently.
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Links:
* Do Quality Differently website and blog
* Get your copy of the book on Amazon
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.
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Show Notes:
(3:09) The process of writing the book.
(8:09) How can companies ask better questions around human performance?
(12:27) Understanding the black and blue line.
(17:24) Building the necessary fluency to enable adoption.
(20:08) The integration of human and organizational performance into the book.
(26:23) Batch losses and how to prevent them.
(30:22) One-line mission of "Do Quality Differently".

For transcripts, check out the podcast website - www.lifesciencespod.com

For transcripts, check out the podcast website - www.lifesciencespod.com

Previous Episode

The Promise and Perils of Large Language Models in Healthcare and AI-based Software as a Medical Device with Vivek Thakkar

Episode 017: Harsh Thakkar (@harshvthakkar) interviews Vivek Thakkar (@vivekbthakkar), the Senior Digital Health Consultant at Biologics Consulting

Vivek emphasizes the importance of validating AI-based software in clinical settings to ensure safety and efficacy. He also discusses the challenges of continuous improvement in algorithms and the need for a predetermined change control plan.
Harsh and Vivek also discuss the role of AI in healthcare, the challenges of regulating AI in medical devices, and how companies can go about validating AI-based software as medical devices. They also touch on the potential for AI to generate outlines for regulatory submissions.
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Links:
* MedPaLM
* FDA draft guidance on predetermined change control plan
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.
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Show Notes:
(3:05) What are the regulations around AI?
(8:59) Clinical research and clinical trials.
(14:15) Regulatory Intelligence and regulatory submissions.
(17:42) Can AI be used to write regulatory submissions?
(22:55) The importance of humans in the loop in healthcare.
(32:21) Will AI take your job?

For transcripts, check out the podcast website - www.lifesciencespod.com

Next Episode

Continuous Validation: The Key to Successful Life Sciences Software with Nagesh Nama

Episode 019: Harsh Thakkar (@harshvthakkar) interviews Nagesh Nama (@nageshnama), the Chief Executive Officer at xLM.

Nagesh shares his perspective on continuous validation and emphasizes the unique capabilities of his platform, which includes the generation of digitally signed PDF reports.
Harsh and Nagesh discuss xLM's platform and its approach to software validation and test automation, as well as challenges related to incorporating AI technology and the importance of data governance
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Links:
* Continuous Validation
* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.
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Show Notes:
(3:28) The concept of continuous validation.
(7:12) What happens if you already work on the platform?
(11:32) The production pipeline for Vmware.
(15:00) Manual vs. AI.
(19:27) Log analysis and audit trails.
(25:59) Man vs. Machines
(30:48) Data Governance and audits.

For transcripts, check out the podcast website - www.lifesciencespod.com

Life Sciences 360 - The Intersection of Theory and Practice in Quality Management: Perspectives from Amy Wilson and Cliff Berry

Transcript

Amy Wilson 00:00
I think an important first note is that the goal is not necessarily to reduce the variation
between, it's just to recognize that it's there. Okay? Because like Cliff said, the blue line is so
dynamic, sometimes that blue line in what's actually happening is better than what you might
expect. And
Harsh Thakkar 00:21
what's up everybody, this is harsh from cultivate.com. And you're listening to the life sciences
360 Podcast. On this show, I chat with industr