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 is 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.

—> Access the Video Recording and Slides!

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.

—> Access the Video Recording and Slides!

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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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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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.

—>Access the Video Recording and Slides

—> If you are a Site or Corporate Quality Officer, you are invited to join the Quality Operations Forum.

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!

• Initiative: Input from this discussion was inlcuded 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 Initiatve 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