Quality Culture Virtual Workshop

This Event Ended April 27, 2021


CQO Mission: The mission of the Chief Quality & Operations Officer Forum is to drive the future of the life science industries by Mobilizing Enterprise-wide Effectiveness. This purpose-driven forum is responsible for the development of actionable outcomes that are advancing the industry and their organizations

Purpose of the Cultural Workshop: to allow the CQO companies to grow and learn with each other in a collaborative setting that supports the mission of the CQO Forum.

Who Can Attend? This event has ended. Anyone from the Chief Quality and Operations Officer Team Organizations was invited to join this FREE event. Check out the CQO Team to see if your company is included: CQO Team Members

Workshop Description

This Quality Culture Workshop provided participants with an opportunity to learn how to apply the learnings from the Xavier/PwC Cultural Metrics work, through which cultural experts were asked: “What would you have to see in action to know a company has a good culture of quality”? The responses were converted into measurable actions that can be implemented by your company. Participants also explored what influences culture (intentionally and unintentionally) to increase the success of cultural leadership. This work has been used by FDA on inspection!

Workshop Handouts and Recordings

The following materials supported the success of the Workshop Participants:

  1. Workshop Slides

  2. Xavier/PwC Cultural Work for FDA Industries - White Paper

  3. Xavier/PwC Pharma Metrics Work - White Paper (applies to device as well)

  4. FDA/Xavier Device Metrics Work - White Paper (applies to pharma as well)

Important Web Links:

  1. Volunteer to become involved with students in the Quality Science Education Program

  2. Join the Quality Culture Maturity Team: Interest Form

  3. Evaluation Form for the Workshop: Evaluation Form

Recordings from the Workshop:

Attendees may use and share these recordings however they wish, as my hope is that this workshop will support your success! We attempted to “chunk” out the recordings into smaller manageable parts, with the approximate slides covered in each video listed below.

1. What Does Good Look Like (38:25). Slides 1 - 7

2. How to Measure (48:13). Slides 8 - 43

3. Behaviors (29:00). Slides 44 - 56

4. Roles and Responsibilities (32:31). Slides 57 - 71

5. Business Processes (9:35). Slides 72 - 80

6. How to Monitor (16:10). Slides 81 - 88

7. Pulling it all Together (7:14). Slides 89 - 96

Questions or Comments? Please contact Marla Phillips.

Workshop Facilitator

 
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Marla A. Phillips, Ph.D.
Marla A. Phillips, Ph.D.

CEO and President

Pathway for Patient Health

[Connect via LinkedIn] Phillips founded Pathway for Patient Health in 2018, and leads cultural, quality and supply chain initiatives with regulators and industry professionals for the betterment of patient health around the world. Phillips is a frequently invited speaker for major industry association conferences across the country each year, including the PDA/FDA Joint Regulatory Conference, AdvaMed Medtech Conference, Cold Chain Global Forum, USP, IPEC, and the FDA’s own Association of Food and Drug Officials.

In 2008, Phillips founded, Xavier Health at Xavier University. In this role, Phillips was asked to co-lead with FDA the CDRH Case for Quality metrics initiative from 2014-2016, which culminated in work that continues to support the Case for Quality program. She led the Good Supply Practices (GSP) initiative with the FDA Office of the Commissioner, CDER, pharmaceutical and medical device professionals, and suppliers, which has been published for global industry adoption. Additionally, Phillips founded the FDA/Xavier PharmaLink Conference, FDA/Xavier MedCon Conference, AI Summit and Combination Products Summit for global regulators and industry professionals.

Phillips began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She has expertise in leading FDA inspections and readiness, quality, analytical testing and validation, supply chain, stability program management, process validation, manufacturing, and packaging operations.

Phillips holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.