Business Success Through QARA Leadership Register Today for the June 2015 Cadre!
The program has been designed for medical device professionals who meet the following criteria:
* Less than 100 employees
- Minimum 3+ years QARA experience
- Classified as high performers
- Some level of TPLC competency
- Leadership potential or in leadership role
The Certificate of Graduate Study includes 10 modules, designed to enhance leadership performance quickly with proven tools, processes, FDA interaction, professional coaching, and more.
Participants will cover the following topics during the 10 month program:
- 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.
- Industry Structure and Stakeholders:
Discussion of external stakeholders, regulatory authorities, competitors, and other business influencers across the industry.
- 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.
- 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.
- TPLC Roadmap:
Introduction of case study and total product lifecycle process to explore technical, regulatory, and leadership aspects required for patient and business success.
- 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.
- 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.
- 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.
- On-Market Stage:
Exploration of leadership requirements after product launch using scenarios, including technical and ethical challenges, organizational expectations, and FDA interactions and expectations.
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.
Students have the opportunity to gain access to the Xavier Health Webinar Toolbox taught by Industry Experts and FDA Officials. The unlimited access allows students to dive deeper into all aspect of the Total Product Lifecycle and better prepare for the Certificate Program:
- Design Controls – 10 webinars
- Medical Device Reporting – 11 webinars
- Post-Market Surveillance – 6 webinars
- FDA Safety and Innovation Act – 2 webinars
- Regulatory Submissions – 6 webinars