This episode has been published on September 17th, 2018
Welcome to the seventh episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends, and to provide awareness and tactical guidance to help strategically facilitate change.
The focus of today’s show is a topic that is near and dear to Mandy’s heart, and that is: the philosophy of quality. She’s joined by a very special guest, Dr. Richard Prince, President and CEO of Now Biopharma; and by her co-host, Philippe Gaudreau, founder and CEO of Solabs. Dr. Richard Prince brings over 3 decades of experience as a successful leader, entrepreneur, executive, teacher and author in Life Sciences. His company, Now Biopharma, provides Life Sciences consultancy services, and also serves as a clinical CRO. They serve as a catalytic agent for companies that have a business need for more rapid and effective drug development programs. They partner with biotechnology, pharmaceutical, and medical establishments to meet complex and time-sensitive priorities within an ever-changing competitive landscape.
In this episode, Mandy and Richard dive deep into what it means to build a quality-centric culture, as well as the potential impacts of not having those fundamental quality threads built into your infrastructure. They discuss how to become successful in a regulated company from a quality perspective, the fundamental building blocks of quality, compliance trends in the industry from the last annual FDA report, how to properly respond to an FDA observation, and Richard’s first principles of building a company culture of quality.
[:51] About today’s topic and guest.
[1:49] About Dr. Richard Prince’s current mission with his company.
[3:47] Richard gives an introduction to today’s topic.
[4:38] How does one go about becoming successful in a regulated company in the pharmaceutical industry from a quality perspective? Richard explains his five-step algorithm that will ensure that you have a higher likelihood of being successful the first time around.
[5:32] Richard explains the first of the five building blocks of quality: Knowledge and know-how.
[7:02] The second building block of quality: Design verification.
[8:03] About the third: Process Fidelity and transparency.
[9:55] About the fourth: Performance metrics.
[10:33] About the fifth and last building block: Rational decision making.
[11:33] Richard reveals what’s remarkable about the compliance trends in the industry from the last, annual FDA report.
[18:09] Mandy’s experience and thoughts on FDA warning letters and observations.
[21:03] Richard emphasizes how to properly respond to an observation (from the FDA.)
[21:53] Drug compliance issues and what the FDA cited them for (in the pharmaceutical industry).
[24:21] Richard outlines the categories of compliance and enforcement actions that the FDA promulgates, what the 483 observation from the FDA is (and how to respond to it).
[31:03] Richards reads what activities the FDA may consider warranting criminal prosecution.
[33:16] Richard reviews some of the First Principles (7 out of 14) that are designed to help build a company culture of quality.
[43:36] Mandy’s take on the First Principles.
[46:03] Richard speaks about what makes some of the most successful companies and quality professionals.
[47:14] Richard discusses the 8th First Principle: the importance of an independent quality unit.
[48:17] Richard explains why courage is an important attribute.
[50:12] Richard goes over the 9th First Principle: Establish suitability of equipment, facilities, utilities and methods.
[50:48] Richard speaks about the 10th, 11th, and 12th First Principles: deploying risk assessment, understanding sources of variability and signals of drift, and understanding the link between safety, efficacy, and quality.
[53:02] Richard explains the 13th and 14th First Principles: Quality is never static and requires continual improvement, and take quality and management action when necessary.
[54:40] Richard reads a couple quotes that really help illustrate the importance of quality.
[56:09] Richard summarizes the characteristics that successful quality systems possess.
[1:00:18] Where to reach Richard and learn more about his company, Now Biopharma, LLC.
[1:02:45] About next week’s episode, how to reach Mandy, and how to contact Richard.
Want a More Immersive Podcast Experience? Download Richard’s Powerpoint Presentation to follow along!
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