Business Success Through QARA Leadership Certificate of Graduate Study (COGS)

Experience the impact our real-world intensive program for High Performers can have in your organization!

The VPs on our Board of Directors expressed that this program “accelerates wisdom that would otherwise take years to acquire.”

How do we accelerate wisdom? This program immerses students in a deep understanding of business success, which is foundationally rooted in, grown by, and driven by patient success.

As a result of our program, students will recognize the importance of approaching every decision they make every day with an understanding of impact to the patients, the global competitive business strategy of their company, the objectives of their organization, their personal objectives, the requirements of government agencies, the goals of their cross-functional stakeholders, the impact to payors, the needs of providers, and the expectations of shareholders… all while applying a greater technical competency in the Total Product Lifecycle. This approach is enhanced with a mastery of Leadership in Balance that responds with agility and effectiveness to the situation at hand.

In the real world, this all has to be done simultaneously…and done well.

Distinctive Features:

  • Increase technical competency across the Total Product Lifecycle
  • Learn directly from FDA faculty
  • Incorporation of customized stage gate model
  • Improve FDA Relations: How, when and why
  • Personalized professional leadership coaching with Action Plans
  • Internal and external stakeholder impact analysis—taught and applied
  • Extensive Development and Application Project
  • Culminating Capstone Experience

Distinguished Faculty Include:

Steve Silverman, Director of the Office of Compliance, FDA

Geeta Pamidimukkala, Biomedical Engineer, Office of Device Evaluation, FDA

Monica Wilkins, Divisional Vice President, Abbott

Bill MacFarland, Director of the Division of Enforcement B, FDA

Steve Niedelman, Lead Quality Systems and Compliance, King & Spalding

Karen Boylan, Vice President, Teleflex

Kathie Bardwell, Senior Vice President and Chief Compliance Officer, STERIS Corporation

Cecilia Kimberlin, Consultant, Kimberlin Consulting

Susan Rolih, Executive Vice President, Meridian Bioscience

Jim O’Reilly, Professor, University of Cincinnati

Bill Brodbeck, Director, STERIS

John Kucia, Vice President, Xavier University

Linda Gravett, Senior Partner, Gravett and Associates

Lindsey McGowan, Senior Director Quality & Regulatory Compliance, STERIS Corporation

Michael Jodon, Senior Regulatory Specialist, STERIS Corporation

Tricia Cregger, Manager, Regulatory Affairs, STERIS Corporation

Tony Piotrkowski, Manager, Regulatory Affairs, STERIS Corporation

Invited Faculty Include:

Gina Brackett, Compliance Officer, FDA

Phil Pontikos, National Device Expert, FDA

Course Overview:

  • Flexible course format completed over 10 months.
  • Students will receive 50 contact hours of content, including two on campus events with 1-on-1 professional coaching sessions.
  • Collaborative and interactive assignments with cross-functional peers, current and former FDA, as well as Industry Executives.

For more information view our brochure, or contact Mason Rick at 513-745-3016.