New! The Pathway Forum

New! The “Quality Operations Forum” has expanded into the new “Pathway Forum”. The Pathway Forum membership includes 3 Centers of Collaboration you can join, with more to come:

  1. Quality Operations Center

  2. Postmarket Innovation Center

  3. AI/Digital Journey Center

  4. And more to come!

Join a network of your global peers in a collaborative environment that enables you to ask questions, share insights and explore solutions.

Digital Quality

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Artificial Intelligence

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Annex 1 Changes

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EU MDR/IVDR Revisions

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Data Integrity

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Quality Culture

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Supply Chain Disruption

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Single Use Systems

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Electronic Batch Records

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Workforce Retention

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Metrics that Matter

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Continuous Process Validation

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Global Inspection Readiness

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Quality Productivity

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Diversity and Inclusion

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Digital Quality 〰️ Artificial Intelligence 〰️ Annex 1 Changes 〰️ EU MDR/IVDR Revisions 〰️ Data Integrity 〰️ Quality Culture 〰️ Supply Chain Disruption 〰️ Single Use Systems 〰️ Electronic Batch Records 〰️ Workforce Retention 〰️ Metrics that Matter 〰️ Continuous Process Validation 〰️ Global Inspection Readiness 〰️ Quality Productivity 〰️ Diversity and Inclusion 〰️

Purpose of the Forum

To support the life science industry in proactively implementing successful practices gained through a vibrant network of global peers collaboratively addressing contemporary and complex challenges.

In today’s world of constantly evolving innovation and regulatory expectations, industry professionals in the life science industry must stay abreast of these changes and work to advance how their company operates for the betterment of patients around the world. We need to move beyond the “challenges” and into the realm of “solutions”, and at Pathway, we believe we can do this…together.


4Q24 External Intelligence Meeting: Cook Medical’s Risk Cockpit

 

Experts from Cook Medical shared how they are centralizing risk to inform their decisions.

Access the Recording for the Q42024 External Intelligence meeting, where our expert speakers:

  • Described the benefits of their Risk Cockpit and moving toward a centralized QMS across plant sites

  • Gave a demo of the Risk Cockpit

  • Described their journey from paper processes and spreadsheets to digitalization  

  • Shared how the system impacts stakeholders across their plant sites and how they are leveraging best practices

  • Shared Challenges throughout the process and on the horizon


Join the Pathway Forum! If you are interested in learning from your global peers and experts throughout the year, join today!

 

 

Town Hall: Meet Dr. Michelle Tarver, newly appointed Acting Center Director of CDRH

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.

Thank you to our partners for helping to spread the word for this collaborative event!


Check us Out!

Check out examples of the live meetings we have been having through this forum:

 

How the Forum Operates

Industry professionals engage in facilitated discussions with each other through a platform that provides consistent opportunities to reach their peers on topics that are most important to them.

Each member can:

  • Select topic-specific groups to join

  • Participate in live meetings

  • Share relevant public news and documents with each other

  • Invite each other to join initiatives

  • Present topics of discussion

  • …And much more!

Examples of How We Engage:

  • Centers of Collaboration. The Pathway Forum has Centers of Collaboration that each person can choose to join. Within these centers are virtual meetings, discussion forums and a resource center to share with each other.

    • Quality Operations Center of Excellence

    • Postmarket Innovation Center of Excellence

    • AI/Digital Journey Center of Excellence

    • And more to come!

  • Quarterly External Intel Meetings. All members are invited to join the quarterly external intelligence meetings, which showcase Subject Matter Experts on topics that are important to the advancement of our industry.

  • Expert Sessions. Members receive special invitations to meetings with the Chief Quality Officer Forum, and live sessions with experts on critical topics. Unprecedented opportunity to ask questions!

  • Online Discussion Forums. Each Center of Collaboration has an online discussion forum for members to ask questions of each other and share insights.

  • Engage with Each Other: Each member can invite other members to join a live meeting they want to host on certain topics, or invite them to participate in industry initiatives.

Ready to Join the Forum?

Join Today: To join your global peers, please complete the Registration Form.

You will be admitted to the Pathway Forum upon:

1.   Successful completion of the registration form. Upon receipt of your registration form, Pathway will review your information and approve your application, or ask any clarifying questions.

2.   Receipt of payment. Soon after payment is received, you will receive an email with login information so that you can immediately start engaging with your peers in the forum platform.

Registration Cost: $150 per year (based on each person’s anniversary date). If you have any questions, please Contact Us.

Group Invoicing: If you wish to receive an invoice for a department, group, or team, please contact Michelle.Rich@Pathway4ph.org


Forum Leadership

Shannon Hoste is an expert in Quality and Regulatory science that spans years within the FDA and industry. As an engineer, Hoste’s expertise includes Human Factors Engineering, Risk Management, New Product Design Development and Digital Health. As the Pathway Chief Scientific Officer and Associate Professor of the Quality Science Education Program, Hoste has a passion for collaborative engagement and learning.

Marla Phillips, Ph.D. is an expert in Quality Operations from the pharma industry, and has led cross-industry initiatives since 2008. Phillips was a Site Quality Officer for Merck, and then led AI, device and pharma initiatives with global regulators for 14 years through Xavier University. As the founder of Pathway for Patient Health, Phillips leads the Chief Quality Officer forum and developed the Quality Science Education Program, which trains global students to join our industry. Phillips has a passion for making a difference, and looks forward to engaging with you.