Episode 31: Guest Tribute Show: ‘Best of’ Moments from the Last Two Seasons!
Release Date: 12/10/2019
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...
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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...
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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,...
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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...
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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...
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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...
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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...
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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...
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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...
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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_outlineWelcome to the 31st 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 today, she is joined by her co-host, Philippe Gaudreau, the founder and CEO of SOLABS.
Today’s show is dedicated to all the SOLABIAN friends who have tuned in for each episode and have supported Automating Quality’s journey for the past two seasons! Mandy and Philippe have been on this thought leadership mission for one and a half years now, partnering with life sciences subject matter experts to bring relevant industry trends and best practices to the forefront.
In this episode, they will be taking a look back at the last two seasons, highlighting some of the best clips from previous episodes. Mandy and Philippe have covered so many topics over the past two seasons — from automated system best practices such as validating your cloud solutions and maintaining data integrity, to various best practices areas like inspection readiness and global inspection trends; as well as current hot topics. For new listeners, this could be a great episode to tune into to find out which episodes you want to go back and listen to next!
So sit back, relax, and enjoy this episode dedicated to all of you — Automating Quality’s listeners!
Key Takeaways:
[:32] Mandy opens up today’s episode by thanking guests and listeners for tuning in for the past two seasons!
[1:54] Philippe thanks Mandy, the guests, and listeners of Automating Quality, and reminisces on their podcast journey.
[3:23] About today’s special ‘best of’ episode!
[4:42] In this first clip, Rachel Fountain speaks about implementing a change management process from episode 1.
[5:29] Jay Turner speaks about optimizing compliance from episode 2.
[5:55] In this episode 3 clip, Mary Senica speaks about evaluating and implementing a software solution.
[6:38] Alan Greathouse speaks about measuring operational effectiveness from this episode 4 clip.
[7:00] Rachel Fountain highlights some do’s and don’ts of change management from episode 5.
[7:36] Rich Greer gives his thoughts on data integrity from this episode 6 clip.
[8:21] In this episode 7 clip, Dr. Richard Prince explains the term ‘local-global’ and why it is so useful to remember.
[9:14] Nathalie Bourgouin explains the main difference between a GMP quality system versus a GCP quality system from episode 8.
[9:47] Graham O’Keefe gives his thoughts on effective training methods for millennials from episode 9.
[10:26] Jay Turner speaks about social and collaborative learning from this episode 11 clip.
[10:57] In this episode 12 clip, Brian McNamara speaks about building an effective training assessment program.
[11:25] Philippe Gaudreau speaks about validating a cloud-based solution from episode 12.
[12:20] In the first episode of the 6-part series (ep. 14), Lisa Helmonds gives her thoughts on some of the key elements of virtual life sciences company.
[13:02] In episode 2/6 of the series (ep. 15) with Lisa, she speaks about some of the qualifications and oversight of contract service providers.
[13:51] In episode 3/6 (ep. 17) of the series with Lisa, she speaks about quality agreements.
[14:55] In episode 4/6 (ep. 18) of the series with Lisa, she gives her thoughts on quality culture.
[15:37] In episode 5/6 (ep. 19) of the series with Lisa, she speaks about management review and quality metrics.
[16:26] In the last episode of the series with Lisa (ep. 20), she speaks about investigation deviations and non-conformances.
[17:01] In this episode 21 clip, Michael de la Torre speaks about GMP inspection analytics.
[17:47] Justin Lacombe gives his thoughts on quality by design from episode 22.
[18:50] Jay Turner speaks about what makes a good facilitator from episode 23.
[19:28] Phil Becker speaks about leveraging a risk-based approach to develop, implement, and maintain your IT program from episode 25.
[20:38] In this episode 27 clip, Kathy Landes speaks about the LIR process.
[21:15] Mandy speaks about data migration from this episode 29 clip.
[22:07] Nathalie Bourgouin speaks about inspection readiness from a GCP and GMP lens.
[22:34] Mandy thanks listeners for tuning in to today’s episode and shares when Automating Quality will be returning for season 3!
Mentioned in this Episode: