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

Developed and taught by Industry Leaders and FDA Officials for high performers!

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.
  • Flexible course format completed over 10 months.
  • Earn three credit hours toward a Xavier University MBA and 5.0 CEUs from the Xavier Health QARA Institute.
  • 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.
  • A comprehensive 35-part Webinar Toolbox is available to students, if desired.
  • Culminating Capstone Experience

Distinguished Faculty Include:

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

Karen Boylan, Vice President, Teleflex

Bill Brodbeck, Director, STERIS

Tricia Cregger, Manager, Regulatory Affairs, STERIS

Linda Gravett, Senior Partner, Gravett and Associates

Michael Jodon, Senior Regulatory Specialist, STERIS

Cecilia Kimberlin, Consultant, Kimberlin Consulting

John Kucia, Vice President, Xavier University

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

Lindsey McGowan, Senior Director Quality & Regulatory Compliance, STERIS

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

Jim O’Reilly, Professor, University of Cincinnati

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

Tony Piotrkowski, Manager, Regulatory Affairs, STERIS

Susan Rolih, Executive Vice President, Meridian Bioscience

Steve Silverman, Director of the Office of Compliance, FDA

Monica Wilkins, Divisional Vice President, Abbott

Invited Faculty Include:

Gina Brackett, Compliance Officer, FDA

Phil Pontikos, National Device Expert, FDA


Syllabus:

Students will participate in the following modules:

  1. Setting the Foundation: Leadership Self-Assessment and 360 Review involving management, peers, and direct reports, used with professional coaching later in course to develop action plan.
  1. Industry Structure and Stakeholders: Discussion of external stakeholders, regulatory authorities, competitors, and other business influencers across the industry.
  1. Your Company Game Plan: Impact of product profile diversity and global economics for unique competitive advantages, with focus on revenue streams, business measures, key strategies of your CEO, and potential effects of major news events.
  1. Leadership in Balance: On-campus experience (2 days) with in-depth sessions on executive management decision making, ethical business situational analyses, professional coaching, and personal action plans with tools.
  1. TPLC Roadmap: Introduction of case study and total product lifecycle process to explore technical, regulatory, and leadership aspects required for patient and business success.
  1. Stage Gate Model Application: Explanation of best practice stage gate model, using case study to illustrate critical aspects of tool and how it can be used.
  1. Design and Development Stage: Continued involvement with case study, exploring design and development stage through plans, inputs, and risk management while using stage gate model to drive decisions and measure success; FDA interaction, including planning and implementation of outcomes, device classification, and verification/validation expectations.
  1. Operations Stage: Interaction with other participants and FDA, working through case study device scenarios to ensure understanding of necessary quality systems for operations, effective leadership, and broader company and regulatory awareness.
  1. On-Market Stage: Exploration of leadership requirements after product launch using scenarios, including technical and ethical challenges, organizational expectations, and FDA interactions and expectations.
  1. Capstone: Formal presentation of the participant’s personal action plan and resulting implementations; situational analysis role play with industry leaders covering key course concepts; professional coaching for assessment of leadership progress and ongoing personal action items.

For more information contact Mason Rick at 513-745-3016.