Supporting Your Success!

Webinar Recording: How to Prove Change-Benefit in 30 Seconds

When your doctor prescribes treatment, you see clear results, but organizational changes rarely come with that same clarity. In this recorded session, Richard Matt, moderated by Marla Phillips, walks through the Benefit-Risk Method, a proven approach for combining before-and-after risk into a single, transparent model, confirming that your changes actually reduce risk, justifying resources to stakeholders, and building a sustainable risk process your teams will maintain. Whether you're evaluating product changes, vendor switches, equipment upgrades, or process improvements, this method applies to any decision.

Recording: Access the Recording and Slides

Webinar Recording: Draining the Data Lake — Get Started with AI in 2 Months, Not 2 Years

Still waiting for your data lake to be ready before starting with AI? This session makes the case that waiting is costing you ground.

William Hahn of Siemens shares how AI can plug into your existing systems using knowledge graphs and ontologies — no data harmonization required. Walk away with a practical path to your first AI outcome, even while the tech is still evolving.

Watch the recording to stop waiting and start delivering.

Recording: Access the Recording and Slides

AI Compliance Roadmap 2026: FDA, EMA, MHRA, Swiss Medic & Beyond

The AI regulatory landscape in life sciences is evolving faster than many organizations realize. If you're implementing AI in GXP environments—or planning to—there are critical developments you need to understand.

Expert: Janeen Skutnik-Wilkinson, Eli Lilly

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The AI revolution is here—but are you ready to validate, regulate, and leverage it with confidence? Our Expert Panel shared:

⚖️ EU AI Meets MDR: Navigate the convergence of EU AI Act, MDR, and ISO/IEC 42001. Learn to integrate compliance into your QMS while driving innovation.

📊Statistical Truth & Business Impact: Decode confusion matrices, navigate false positives vs. negatives, and apply FDA-aligned frameworks to assess black-box AI models in GxP environments.

Experts: Attrayee Chakraborty, Andy O’Connor and Priya Setty

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Our expert panel explored the critical intersection of compliance and innovation in process validation such as:

✅ Integrating digital tools into validation workflows

✅ Taking first steps and managing two systems - temporarily

✅ Implementing real-time process monitoring systems to improve validation assurance

Learn actionable insights into practical steps for creating robust, future-ready validation programs that ensure patient safety worldwide. Transform how your organization approaches validation in today's digital-first environment.

Expert Panel: Christine Kattappuram, Marla Phillips, Neal Schmidt

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Blind spots in your Quality Management System can cripple operations, endanger patients, and trigger devastating enforcement actions. Gain insights on the "why" behind the most common deficiencies encountered during FDA inspections, and learn risk-based strategies that deliver immediate, actionable results.

Experts: Phil Pontikos (Former FDA National Expert and Investigator) and Ben Dastoli (Former FDA Investigator and Specialist)

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Whether you are:
>Just starting to explore AI
>Wondering how AI might impact your work
>Looking to understand practical use cases
>Hoping to learn from others' experiences

This complimentary session was designed for professionals eager to understand AI's potential in Quality.

Expert: Brian Chviruk, Quality Systems Operation Leader at Takeda, walked through a specific use case, sharing lessons learned and practical insights.

Recording: Access the Recording and Slides

Marla Phillips interviewed FDA's Dr. Jeff Shuren and Dr. Michelle Tarver. It was an excellent opportunity to get to know the new leader of CDRH, and gain insight on what to expect as the role transitions from Jeff to Michelle.

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Cook Medical described the benefits of their Risk Cockpit, demonstrating how centralizing risk management through a unified QMS across plant sites has transformed their operations. Their presentation covered the journey from paper processes to digital solutions.

Experts: Tom McGhie and Richard Phillips

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Learn innovative approaches to complaint management that enable you to protect the patients who are counting on you through our “Complaint Management Challenges and Innovation” External Intelligence webinar. 

Experts: Kate Gillespie (J&J) and Mike Salem (Gilead)

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Learn how to conduct failure investigations in a way that prevents recurrence, so your company can get products to the patients who are counting on you! In this session, you will explore real world scenarios, tools and techniques that you can start using today!

Expert: Marla Phillips (Pathway, former Merck)

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Gain insights into FDA’s FY23 inspection data and innovative approaches to address gaps for the betterment of patients around the world.

Experts: Mary Farbman (Merck, former FDA), Marla Phillips (Pathway, former Merck), Shannon Hoste (Pathway, former FDA) and Kyle McCracken (Boston Scientific, former FDA).

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The success of your organization depends on continuous improvement, especially when you are faced with challenges that prevent your employees from doing their best…every day. Employee feedback is invaluable, and yet it is so often ignored because it can be overwhelming.

Learn how to use a cool tool that we created which provides a transparent way to capture ideas, and has employees use the risk ranking system to appropriately prioritize the ideas and take action.

Expert: Marla Phillips (Pathway, former Merck)

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Kim Trautman, former FDA and Internationally renowned expert and Jodi McCann, Head of Quality, Cook Medical Australia came together to share insights on MDCG Guidances, Challenges in Inspection Approaches, and Real Inspection Experiences.

Experts: Kim Trautman (former FDA) and Jodi McCann (Cook Medical)

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Gain insight on the key aspects of transitioning from the medical device FDA regulations “QSR” to QMSR. Topics covered ranged from “Why ISO 13485” to “What is the role of Risk Management?”

Expert: Eric Henry (King & Spalding, Senior Quality & Regulatory Compliance Advisor for FDA and Life Sciences and International Expert)

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Link to Federal Register - QSR Amendments

Covid shutdown caught us off-guard for how to lead our operations through extreme emergency conditions - on every front. We hosted a live meeting to share a model and tools on how to vary implementation of your Quality Management System across the total product lifecycle!

Expert: Marla Phillips (Pathway, former Merck)

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Initiative: Input from this discussion was included in the Fit-for-Purpose Initiative that was chartered by the Chief Quality Officer Team

Tools: Check out the Final Report and Tools available for you to use!

As part of the Adaptability and Agility Maturity Model chartered by the Chief Quality Officer Team, we led a live meeting to explore the role and impact of Quality across the maturity continuum.

Expert: Marla Phillips (Pathway, former Merck)

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—> Check out the Maturity Initiative insights!

Learn through the engaging panel discussions and role plays during this webinar that drive key takeaways you can implement today!

Experts: Steve Niedelman (King & Spalding, and former FDA Deputy Associate Commissioner), Marla Phillips (Pathway, former Merck)

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Badge: Want more? We developed an entire Badge on Inspection Readiness. Check it out!

Gain great insight on the top 3 threats to your quality management system. Pathway Forum Members analyzed FDA’s published findings across pharma, device and biologics.

Expert: Marla Phillips (Pathway, former Merck)

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