Supporting Your Success!

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. Don't let hidden vulnerabilities derail your business.

Learn from Phil Pontikos (Former National Expert and Investigator, FDA) and Ben Dastoli (Former Investigator and Specialist, FDA).

Gain insights on the "why" behind the most common deficiencies they encountered during inspections, sharing risk-based strategies that deliver immediate, actionable results.

Whether you are in pharma, medical devices, animal health, cosmetics, or consumer goods – this session will equip you with practical takeaways you can implement today.

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.

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

Recording: Access the Video 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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Access the Recording for the Q42024 External Intelligence meeting where experts Tom McGhie and Richard Phillips from 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, showcasing how this system impacts various stakeholders and enables the sharing of best practices.

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The Pathway Quality Operations Forum hosted a complimentary meeting on “Complaint Management Challenges and Innovation” as part of its External Intelligence series. 

Our expert speakers Kate Gillespie (J&J) and Mike Salem (Gilead) shared innovative approaches to complaint management that enable you to protect the patients who are counting on you.

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Join Failure Investigations expert, Marla Phillips, to learn how to conduct and write investigations. Failures shut down your operations, cost money and waste precious time. 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, Phillips shares real world scenarios, tools and techniques that you can start using today!

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The Quality Operation Forum’s 2nd Quarter External Intelligence meeting focused on insights into FDA’s FY23 inspection data and innovative approaches to address gaps for the betterment of patients around the world. Insights were shared by Mary Farbman (Merck), Marla Phillips (Pathway), Shannon Hoste (Pathway) and Kyle McCracken (Boston Scientific). Several of the panelists have former FDA backgrounds.

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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 during a recent Quality Operations Forum meeting. This tool provides a transparent way to capture ideas, and has employees use the risk ranking system to appropriately prioritize the ideas and take action.

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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.

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Eric Henry (King & Spalding, Senior Quality & Regulatory Compliance Advisor for FDA and Life Sciences and International Expert) provided an overview of the transition from QSR to QMSR. Topics covered ranged from “Why ISO 13485” to “What is the role of Risk Management?”

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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!

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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.

Recording: access the Video Recording Here (20 minutes)

Initiative: Check out the Maturity Initiative insights!

Steve Niedelman (King & Spalding, and former FDA Deputy Associate Commissioner) joined Marla Phillips (Pathway, and former Merck) in this highly engaging webinar on Inspection Readiness. Participants joined breakout rooms and shared ideas in chatbox discussions while Steve and Marla “entertained” them with role plays that drove key takeaways!

Recording: access the Video Recording

Slides: access the Slides

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

We gained great insight together on the top 3 threats to your quality management system. Forum Members analyzed FDA’s published findings across pharma, device and biologics and joined a discussion with the Chief Quality Officer Team.

Recording: Access the Video Recording

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!

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