Call them changemakers. Call them rule breakers. We call them Redefiners. And in this provocative podcast, we explore how daring leaders from across industries and around the globe are redefining their organizations—and themselves—to create extraordinary impact in today’s rapidly changing world. In each episode, Russell Reynolds Associates Leadership Advisor Hoda Tahoun and former CEO Clarke Murphy host engaging, purposeful conversations with leaders in and out of the business world who shar ...
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Episode 59: Introduction to Investigations with Michael Tyo
Manage episode 442933893 series 2364916
Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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 investigations, from why they exist to how they must be performed
02:22 Why are we doing investigations?
04:21 What may trigger an investigation?
08:04 What must be investigated?
10:00 Who is responsible for doing investigations?
14:41 What are the tasks once the investigation is launched?
Contact Michael at mtyo@tyobio.com, Tyo Biotechnology Consulting
Contact solabs at solabs-podcast@solabs.com
60 episodes
Share
Manage episode 442933893 series 2364916
Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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 investigations, from why they exist to how they must be performed
02:22 Why are we doing investigations?
04:21 What may trigger an investigation?
08:04 What must be investigated?
10:00 Who is responsible for doing investigations?
14:41 What are the tasks once the investigation is launched?
Contact Michael at mtyo@tyobio.com, Tyo Biotechnology Consulting
Contact solabs at solabs-podcast@solabs.com
60 episodes
All episodes
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Automating Quality
1 Episode 60: Investigative Methods with Michael Tyo 18:34
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Play Later Play Later Lists Like LikedWelcome 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 things go wrong 03:36 The Fishbone method 06:28 Why human error cannot be a root cause? 07:55 The 5 Whys method 09:35 What needs to be included in the investigation report? 11:30 What does the FDA expect from investigations? 12:38 Lessons from recent FDA’s warning letters Contact Michael at mtyo@tyobio.com , Tyo Biotechnology Consulting Contact solabs at solabs-podcast@solabs.com…
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Automating Quality
1 Episode 59: Introduction to Investigations with Michael Tyo 18:31
18:31 Play Later Play Later Lists Like Liked18:31
Play Later Play Later Lists Like LikedAutomating 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 investigations, from why they exist to how they must be performed 02:22 Why are we doing investigations? 04:21 What may trigger an investigation? 08:04 What must be investigated? 10:00 Who is responsible for doing investigations? 14:41 What are the tasks once the investigation is launched? Contact Michael at mtyo@tyobio.com , Tyo Biotechnology Consulting Contact solabs at solabs-podcast@solabs.com…
A
Automating Quality
1 Episode 58: Discovering AIBOM and the Future of SBOM with Joseph Silvia 15:12
15:12 Play Later Play Later Lists Like Liked15:12
Play Later Play Later Lists Like LikedWelcome 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, and we frequently refer to him for his regulatory expertise. Key Takeaways; 01:05 Introducing guest Joseph Silvia 02:20 What is the concept of AIBOM? 04:23 Why AIBOM and SBOM should be separate discussions 07:45 How does open-source software impact those bills of material 11:22 How do you assess the risk of an AIBOM? Contact us at solabs-podcast@solabs.com…
A
Automating Quality
1 Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia 16:36
16:36 Play Later Play Later Lists Like Liked16:36
Play Later Play Later Lists Like LikedWelcome 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 knowledgeable about the regulatory landscape, and we frequently refer to him for his regulatory expertise. Key Takeaways 01:10 Introducing today’s guest: Joseph Silvia 02:35 What is an SBOM? 04:24 What is the history of SBOM? 05:50 Now, the government is getting involved and SBOM is picking up steam. 06;35 What is the FDA’s expectation on this topic for the medical devices industry? 09:03 When implementing or developing a device, how do you ensure that you have an SBOM in place to support it? 11:38 Who is responsible for SBOM within organizations? 14:37 Where can listeners learn more about this topic? Reach Joseph at jsilvia@medwarecyber.com Contact us at solabs-podcast@solabs.com…
A
Automating Quality
1 Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam 18:08
18:08 Play Later Play Later Lists Like Liked18:08
Play Later Play Later Lists Like LikedWelcome 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 helping clients implement strategies for being and staying inspection-ready. Key Takeaways 01:18 Introducing today’s guest, Caroline Guay-Adam. 02:46 The importance of verifying the effectiveness of corrective actions. 04:55 Focus on what the inspector will be interested in. 06:11 Update the documentation whenever there is a change. 08:48 Employees need to be continuously prepared for inspections. 11:58 You need to have a dedicated Inspection Manual. 16:25 What is the expectation in terms of control of the inspection readiness program? Join us at solabs-podcast@solabs.com Reach out to Caroline at cguayadam@skillpadcompliance.com !…
A
Automating Quality
1 Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam 15:19
15:19 Play Later Play Later Lists Like Liked15:19
Play Later Play Later Lists Like LikedWelcome 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 for being and staying inspection-ready. Key Takeaways: 00:42 Introducing today’s guest: Caroline Guay-Adams 03:23 Why is inspection readiness necessary for Life Sciences companies? 05:24 How do you establish a strategy to be and stay inspection-ready? 08:00 What are the requirements for a company to call itself inspection-ready? 13:00 Which mindset is necessary for this strategy to remain successful over time?…
A
Automating Quality
1 Episode 54: Risk Management Tools and Techniques with Michael Tyo 15:32
15:32 Play Later Play Later Lists Like Liked15:32
Play Later Play Later Lists Like LikedWelcome 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 an SOP for risk assessment Contact us at solabs-podcast@solabs.com…
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Automating Quality
1 Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo 18:35
18:35 Play Later Play Later Lists Like Liked18:35
Play Later Play Later Lists Like LikedWelcome 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 letters in 2023 08:52: How warning letters give you an idea of what happened at the company 12:31: Understanding warning letters helps companies avoid the FDA’s attention Contact us at solabs-podcast@solabs.com…
A
Automating Quality
1 Episode 52: Supplier Quality Management w. Mandy Gervasio 17:28
17:28 Play Later Play Later Lists Like Liked17:28
Play Later Play Later Lists Like LikedWelcome 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 able to work with partners that allow you to operate as one team in a seamless way is an incredible success factor 04:37 Mandy points red flags when entering a relationship with a supplier 07:15 Communicating only when there are problems to manage is a risky behavior 09:03 From a GCP perspective, how can you establish a good relationship with CROs and other suppliers? 13:26 How do you maintain your relationship with those suppliers and keep the trust alive and active?…
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Automating Quality
1 Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio 20:30
20:30 Play Later Play Later Lists Like Liked20:30
Play Later Play Later Lists Like LikedWelcome 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. 06:24: Accountability now revolves around individual responsibilities. 10:21: Data integrity is a recurring theme in discussions. 14:30: Training on data integrity has evolved in recent years. 16:07: Supplier Management is another important topic. Contact us at solabs-podcast@solabs.com…
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Automating Quality
1 Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve 16:06
16:06 Play Later Play Later Lists Like Liked16:06
Play Later Play Later Lists Like LikedWelcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this very special 50th episode! We are joined today by Jamie Villeneuve, CEO and Head of Software Development at NexGen Analytics. Jamie will discuss the common challenges GMP shopfloor companies have in terms of analytics, how this evolved over time, and more! Key Takeaways 01:01 Introducing today’s return guest: Jamie Villeneuve from NexGen Analytics 02:35 What are some of the common challenges in GMP companies from an analytics standpoint? 05:01 What departments need input from analytics? 07:31 How has analytics evolved over time for GMP companies? 10:11 New nomenclature and approach for analytics 11:38 Why do companies invest more and more in analytics? 13:03 The top 5 metrics GMP shopfloor analytics companies need to track 14:42 Thank you to Jamie for joining us for this special episode #50! Contact Jamie at jvilleneuve@solabs.com Contact us at solabs-podcast@solabs.com…
A
Automating Quality
1 Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve 16:07
16:07 Play Later Play Later Lists Like Liked16:07
Play Later Play Later Lists Like LikedWelcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! We are joined today by Jamie Villeneuve, Owner and Head of Software Development at NexGen Analytics. Jamie will discuss the design of analytics from establishing the organization's goals to providing the right information to the right people at the right time. Key Takeaways 01:58 Introducing today’s guest: Jamie Villeneuve from NexGen Analytics 03:19 Who needs information from analytics in an organization? 05:36 How do you know what information is relevant to report on? 08:52 How do you communicate analytics effectively to all staff at a company? 11:40 Is there a process to review metrics over time and ensure what is measured stays up to date with the company’s needs? 15:12 Thank you to Jamie for joining us! Contact Jamie at jvilleneuve@solabs.com Contact us at solabs-podcast@solabs.com…
A
Automating Quality
1 Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia 14:18
14:18 Play Later Play Later Lists Like Liked14:18
Play Later Play Later Lists Like LikedWelcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! We are joined today by return guest Joseph Silvia, Director, Software Quality Training, and Instructor at Oriel STAT A MATRIX. In this episode, Joe shares his expertise on Supplier Management Quality for the medical devices industry. We discuss the onboarding process of new suppliers, the future of remote versus on-site audits, and more! Key Takeaways 00:38 Introducing Joseph Silvia and Oriel STAT A MATRIX 02:53 Who are the main parties involved in the medical devices supply chain? 04:15 What is the process to getting a new supplier on board? 07:56 Are all audits in the future going to be remote? 10:04 Do suppliers change their processes to make themselves easier to audit? 12:55 Thanks to Joseph and our listeners for this great episode!…
A
Automating Quality
1 Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia 19:02
19:02 Play Later Play Later Lists Like Liked19:02
Play Later Play Later Lists Like LikedWelcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! Our guest today is Joseph Silvia, Director, Software Quality Training and Instructor at Oriel STAT A MATRIX. Joe shares his expertise on the Case for Quality, what to focus on first when implementing a quality system and the differences between Computer Software Validation (CSV) and Computer Software Assurance (CSA), and more! Key Takeaways 02:17 Introducing today’s guest: Joseph Silvia, Director of Software Quality Training and Instruction and Lead Auditor at Oriel Stat A Matrix 03:33 What is the Case for Quality? 05:23 Joseph discusses the importance of having quality at the core of what you do as opposed to adding it as an afterthought 07:44 What is the first thing you should focus on when implementing a quality system? 10:55 Philippe shares his experience on implementing QM10 at SOLABS as part of our quality practices 12:53 The difference between Computer Software Validation (CSV) and Computer Software Assurance (CSA) and how this is impacting risk management 17:38 Thanking Joseph and our listeners for today’s episode! Contact Joseph at jsilvia@orielstat.com or on LinkedIn Oriel STAT A MATRIX: www.orielstat.com Reach out to us at solabs-podcast@solabs.com…
A
Automating Quality
1 Episode 46 - Defining Data Quality with Steve Gens 17:38
17:38 Play Later Play Later Lists Like Liked17:38
Play Later Play Later Lists Like LikedWelcome to 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 features Steve Gens, Managing Partner at Gens & Associates. We will define data quality, what happens if the confidence in data quality is low, and provide some recommendations to keep it high. Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021. Key Takeaways 00:49 Introducing today’s guest: Steve Gens, here to discuss Data Quality with us 02:10 Defining Data Quality? 04:00 What happens when the confidence in the data quality is low? 05:48 Steve provides some recommendations related to Data Quality. 10:30 How does Data Quality bring Quality and Regulatory together? 13:26 what are some services Gens & Associates offer related to this topic? Reach out to us at solabs-podcast@solabs.com…
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Call them changemakers. Call them rule breakers. We call them Redefiners. And in this provocative podcast, we explore how daring leaders from across industries and around the globe are redefining their organizations—and themselves—to create extraordinary impact in today’s rapidly changing world. In each episode, Russell Reynolds Associates Leadership Advisor Hoda Tahoun and former CEO Clarke Murphy host engaging, purposeful conversations with leaders in and out of the business world who shar ...
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