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.

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.

—> Access the Video Recording!

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!

—> Access the Video Recording, Slides and Tool!

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.

—> Click Here to Access 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 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.

—> Recording and Slides: Access the Video Recording, Slides and Tool!

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.

—> Click Here to Access Recording and Slides

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

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?”

• Recording and Slides: 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!

• 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

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)