Automating Quality

Welcome to  Automating Quality , the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments. In Part 2 of this three-part series, Mandy and Philippe continue the conversation with Niyati Patel, Strategic Quality and Compliance Advisor, shifting from theory to execution: how organizations are operationalizing AI in GxP environments. This...

Welcome to Automating Quality , the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments. In this episode, Mandy and Philippe are joined by Niyati Patel, Strategic Quality and Compliance Advisor with 20+ years of experience across pharma, biotech, medtech, and regulated digital implementations. Niyati specializes in the intersection o...

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In this episode, our host Philippe welcomes Paul Michel, Senior Consultant at SkillPad, with over 27 years of experience in the pharmaceutical and biopharmaceutical industries, including more than two decades in manufacturing. Paul specializes in GMP training, compliance re...

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In this episode, our host Philippe welcomes Masha Ivankovic , President and Owner of Monbel Consultants . With more than 15 years of experience supporting pharmaceutical and biotech companies, Masha has led complex engineering, validation, and regulatory projects across hig...

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In today's episode, our host Philippe welcomes Jim Ferguson, President and Owner of NuQual Consulting. With over 25 years of experience in the life sciences industry, Jim brings deep expertise in supplier quality and compliance. Together, they dive into the world of interna...

Welcome to Automating Quality , the life sciences–focused show that bridges the gap between automation and quality management. In today's episode, Ed and Philippe explore how quality can bring added value to a company and discuss strategies to shift organizational mindsets to unlock the full potential of quality departments. Ed Siurek brings over 30 years of hands-on experience in applying 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. Mi...

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 q...

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...

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...

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!   Car...

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 ye...

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...

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 bac...

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 re...

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...

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 50 th 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 an...

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...

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...

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...

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...

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 & Ass...

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...

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...

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...