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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]
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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]
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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]
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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]
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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]!
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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?
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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]
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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]
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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?
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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]
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Welcome 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 [email protected]
Contact us at [email protected]
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Welcome 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 [email protected]
Contact us at [email protected]
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Welcome 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!
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Welcome 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 [email protected] or on LinkedIn
Oriel STAT A MATRIX: www.orielstat.com
Reach out to us at [email protected]
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Welcome 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 [email protected]
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Welcome 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 discuss the World Class RIM Benchmark conducted by Gens & Associates, how it came into being, and some of its key findings over time.
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
00:45 Introducing today’s topic: The World Class RIM Benchmark by Gens & Associates
01:15 Steve Gens’ Background
02:20 How did the World Class RIM come into being?
05:03 The origin of the RIM acronym
06:00 Steve shares some of the key findings of the benchmark over time
11:21 What does the industry need to get better?
13:10 Where does clinical stand compared to regulatory in terms of standardization
15:15 Is there a correlation between the ROI on new technology and having robust processes?
16:00 What has evolved over time in between those studies?
19:00 What would Steve recommend to students interested in the topic of RIM?
21:30 Thank you to our listeners!
Contact us at [email protected]
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Welcome 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 guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.
The topic of today’s episode is good machine learning practices for the medical devices industry. Ben discusses some good machine learning practices (GMLP) and discusses the importance of standardizing those across the industry over time.
Key Takeaways
01:00 Today’s topic is good machine learning practices for the medical devices industry
01:20 Introducing today’s guest: Ben Locwin
03:30 Ben introduces good machine learning practice guiding principles
06:43 How quickly will there be a set standardized framework for good machine learning practices (GMLP)?
11:10 Why this topic matters a lot
12:15 Will new competencies need to be developed for understanding the regulations and techniques in the field of machine learning?
14:36 Thank you to our guests and listeners!
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Welcome 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 guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.
Today’s topic of discussion is artificial intelligence and machine learning. Ben delivers some background on those buzzwords, how they relate to the FDA’s action plan, how this will impact the medical device industry moving forward, and more!
Key Takeaways
01:22 Introducing today’s guest Ben Locwin
03:26 Some background on artificial intelligence and machine learning
05:24 Common misunderstandings about those buzzwords
07:10 What is deep learning versus machine learning and AI?
08:43 How do these areas relate to the FDA’s action plan?
14:05 How will this impact the medical device industry moving forward?
18:40 Mandy thanks Ben for joining us on the show
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Welcome 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! In today’s episode, we will discuss the discoveries of the Quality Benchmark conducted by Gens & Associates in late 2021.
Our guest today is Katherine Yang-Iott. She is a consultant and analyst for Gens and Associates and the study lead for the firm’s first Quality-focused benchmark. She’s had 2 decades of experience as a scientist and researcher.
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
01:32 Introducing today’s guest: Katherine Yang-Iott, an Analyst at Gens & Associates
03:07 Katherine introduces Gens & Associates and the context of this study
06:07 What were the key findings of this survey?
08:50 What is a QMS in the perspective of Katherine
11:12 What was the goal of the study in terms of information produced?
14:20 How the pandemic has increased companies’ focus on supplier management
20:00 Mandy mentions that CAPA is a quality process that companies still struggle to get right today
21:20 Philippe shares his thoughts on the benchmark’s key learnings
22:57 What are the next steps for G&A in the world of quality?
25:15 Mandy thanks our guest and invites listeners to share their feedback
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Welcome 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 guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.
The topic of today’s discussion is the Real-World Evidence framework as defined by the FDA. We highly recommend listening to the previous episode on Real-World Data and Real-World Evidence before diving into this one.
Key Takeaways
00:17 Mandy introduces Ben back to the show
01:13 Today’s topic is the Real-World Evidence framework
02:24 What is the FDA’s definition of Real-World Evidence?
06:50 What is being looked at for the framework?
09:16 What are the 4 Vs of data?
11:18 How do you define your hypotheses in advance when looking at data?
15:44 Mandy reflects on today’s discussion
- Visa fler
