loader from loading.io

Episode 32: Major Trends in Automation for the Life Sciences Industry in 2020

Automating Quality

Release Date: 01/21/2020

Episode 60: Investigative Methods with Michael Tyo show art Episode 60: Investigative Methods with Michael Tyo

Automating Quality

Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management. In today’s episode, Michael and Philippe discuss investigation methods, how to apply them in detail, and the various tools available for conducting investigations.   Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting.   Key Takeaway 01:24 Introducing today’s guest: Michael Tyo 01:55 Today’s topic is investigative methods and what happens when...

info_outline
Episode 59: Introduction to Investigations with Michael Tyo show art Episode 59: Introduction to Investigations with Michael Tyo

Automating Quality

Automating Quality Episode 59 – Inspection Readiness with Michael Tyo   Welcome to Automating Quality, the Life sciences-centric show that bridges the gap between automation and quality. In today’s episode, we discuss inspection readiness, from why we are doing them to how to conduct investigations properly.   Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting.   Key Takeaways 00:42 Introducing today’s guest: Michael Tyo 01:42 Today’s subject is the...

info_outline
Episode 58: Discovering AIBOM and the Future of SBOM with Joseph Silvia show art Episode 58: Discovering AIBOM and the Future of SBOM with Joseph Silvia

Automating Quality

Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the second in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. In this episode, we discuss the definition of AIBOM, how it differs from SBOM, and take an educated guess at their future. Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely knowledgeable about the regulatory landscape,...

info_outline
Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia show art Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia

Automating Quality

Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the first in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. We explore the history of SBOM, its current importance for the FDA, and how to ensure you have an SBOM in place when implementing or developing medical devices.   "Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely...

info_outline
Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam show art Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam

Automating Quality

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This episode is the second in a series on Inspection Readiness featuring guest Caroline Guay-Adam! In this episode, we dive into tips and tricks for maintaining Inspection Readiness including first time right, the importance of the Inspection Manual, and more!   Caroline Guay-Adam has over 15 years of experience as a quality professional before joining Skillpad as a Senior Compliance Consultant. She has plenty to share on compliance and has recently been...

info_outline
Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam show art Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam

Automating Quality

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, we discuss a topic key to the heart of most quality professionals: inspection readiness! Our guest Caroline Guay-Adam discusses inspection readiness and how to reach and maintain an inspection-ready state over time. Caroline Guay-Adam has over 15 years of experience as a quality professional before joining Skillpad as a Senior Compliance Consultant. She has plenty to share on compliance and has recently been helping clients implement strategies...

info_outline
Episode 54: Risk Management Tools and Techniques with Michael Tyo show art Episode 54: Risk Management Tools and Techniques with Michael Tyo

Automating Quality

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a discussion on risk management tools. They discuss the importance of a risk plan and a risk assessment SOP, plus the FDA’s expectations regarding the use of risk assessment tools.   Key Takeaways: 01:11 Introducing Michael and his Background 02:31 Does the FDA have a clear expectation for the use of risk assessment tools? 06:13 The importance of a risk plan 09:20 Why companies must all have...

info_outline
Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo show art Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo

Automating Quality

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo discusses how warning letters can be leveraged as a source of information on the FDA’s current areas of focus and how monitoring them can help avoid the FDA’s attention.   Key Takeaways 01:04: Michael introduces himself and his background 02:21: How can companies use warning letters as a source of information on the FDA’s current area of focus 04:31: Michael shares a statistical analysis he conducted on warning...

info_outline
Episode 52: Supplier Quality Management w. Mandy Gervasio show art Episode 52: Supplier Quality Management w. Mandy Gervasio

Automating Quality

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by  Philippe Gaudreau, CEO at SOLABS, and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma.   In this episode, Mandy and Philippe discuss supplier management from establishing a relationship with new suppliers to maintaining this relationship and keeping the trust between your two organizations alive.   Key Takeaways: 01:30 Mandy discusses her current role and how it is linked to supplier management 03:40 Being...

info_outline
Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio show art Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio

Automating Quality

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma.   In this episode, we explore Mandy’s takeaways from recent quality conferences she attended, from management accountability to the importance of managing data integrity.   Key Takeaways 02:06: What are the key conferences Mandy attended this year? 04:49: The importance of keeping management accountable for quality objectives....

info_outline
 
More Episodes

Welcome to the 32nd 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!

 

Today’s episode is kicking off season 3! Mandy is joined by her co-host, the CEO and founder of SOLABS, Philippe Gaudreau. Together, they will be discussing some of the major trends in automation for the life sciences industry in 2020. 

 

If you want to know about the upcoming hot topics and trends to be aware of and prepare for in order to stay current and competitive in this ever-changing business landscape, be sure to tune in! These hot trends will be sure to add value to your current and future roles in the space of life sciences.

 

Key Takeaways:

[:25] About today’s episode!

[1:13] Mandy thanks listeners for tuning in through seasons 1 and 2.

[1:49] Philippe joins in to thank listeners as well, and speaks a bit about what to expect for today’s episode.

[3:13] Hot topic areas that are increasing visibility and growth for the life sciences.

[6:28] Mandy elaborates on the notion of data analytics.

[7:33] Philippe shares his perspective on big data and data analytics and where it’s headed in terms of driving changes within life sciences.

[11:41] The way technology is shifting in life sciences.

[13:16] Progress in mobile med device apps and wearable tech.

[14:50] Philippe’s thoughts on mobile med device apps and wearable tech.

[17:54] What blockchain technology is and how it is entering the life sciences.

[19:29] An upcoming hot trend (to be discussed in a future episode): serialization.

[20:11] Wrapping up the show, Philippe gives some thoughts on another hot trend: single sign-on solutions.

[24:35] Mandy wraps up the show and thanks listeners for tuning in as always!

 

Mentioned in this Episode:

Automating Quality Ep. 21: “Michael de la Torre on GMP Inspection Analytics”

Automating Quality Ep. 29: “Data Migration and Data Integrity with Philippe Gaudreau”

[email protected]

Philippe Gaudreau on LinkedIn