Industry and regulators are working collaboratively to increase the assurance of product quality, instead of focusing purely on compliance. On the heels of FDASIA (FDA Safety and Innovation Act) of 2012, CDER was officially given the authority to appropriate its resources based on risk. CDER launched its metrics initiative to identify what information it could gather and use to delineate risk across industry sites across the nation. Throughout 2012 to the present, industry members have been engaging with regulators to determine how best to measure the commitment to quality, and have recognized the intertwining nature of risk, KPI and culture.

Join this workshop, facilitated by Tami Frederick (Perrigo) and Marla Phillips (Xavier University, formerly with Merck), to advance the effectiveness of how your company measures quality. The Risk, Metrics and Culture: Empowering Your Organization Workshop takes place Tuesday, March 17, 2020, from 8:30am-4:00pm EDT.

Workshop Outcome

Through this hands-on, practical workshop, you will be able to assess your current practices against advanced practices that can improve the performance of your operations. Together, we will explore, discuss and analyze the:

  1. Assessment of shortcomings of Common KPI.

  2. Identification of true “Key Performance Indicators” across the Total Product Lifecycle, and how to build an effective enterprise-wide feedback loop that prevents future failure.

  3. Determination of risk to your product, process, patients and business such that your energy is focused in the right direction, with meaningful and measurable outcomes.

  4. Impact of being able to truly measure culture for the first time. It can be measured…find out how!

  5. Aggregation of all that is important to you in a way that informs your future decisions.


The following are resources, to download and review, which will be used throughout the workshop:


The Risk, Metrics and Culture: Empowering Your Organization Workshop, Tuesday, March 17, 2020, from 8:30am-4:00pm EDT, is just $850. Registration for government officials is just $49.

About the Workshop Facilitators