Kim Trautman is an internationally renowned expert, who helped write the FDA medical device regulations, and is intricately involved in global standards and harmonization efforts amongst regulators.

Jodi McCann is the Head of Quality for Cook Medical’s plant site in Brisbane Australia. Jodi will share inspection experiences they have had under the new EU MDR.

Eric Henry is a gifted expert who dives into complex rule-making, standards and regulations, and resurfaces with clear, key take-aways that the global industry has come to rely upon. He is a Senior Quality & Regulatory Compliance Advisor for King & Spalding.

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

Recording: Access the Recording and Slides

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

Recording: Access the Recording and Slides

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

Recording: Access the Recording and Slides

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)

Recording: Access the Recording and Slides

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.

—> Access the Video Recording and Slides!

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

—> Access the Video Recording and Slides!

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)

—> Access the Video Recording and Slides!

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)

—> Access the Video Recording and Slides

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).

—> Access the Video Recording and Slides

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)

—> Access the Video Recording and Slides

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)

—>Access the Video Recording and Slides

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)

Access the Video Recording and Slides

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)

—> Access the Video Recording

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)

—> Access the Video Recording (20 minutes)

—> 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)

—> Access the Video Recording and the Slides

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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Part of Building your personal brand is understanding how to portray yourself on a professional networking site, and why. Through this series, you will learn how to make the most of LinkedIn, what to do, and what not to do!

—> Access the Series

Marla Phillips, Ph.D.

CEO & President

Pathway for Patient Health (Former Merck)