By SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests
5
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The podcast currently has 60 episodes available.
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 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 [email protected], Tyo Biotechnology Consulting
Contact solabs at [email protected]
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 [email protected], Tyo Biotechnology Consulting
Contact solabs at [email protected]
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, 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 [email protected]
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 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 [email protected]
Contact us at [email protected]
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 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 [email protected]
Reach out to Caroline at [email protected]!
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 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?
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 an SOP for risk assessment
Contact us at [email protected]
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 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 [email protected]
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 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?
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.
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 [email protected]
The podcast currently has 60 episodes available.