The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

This course provides an in-depth discussion of Six Sigma process improvement strategies, tools, and concepts as applied to pharmaceutical research and manufacturing. Design for Six Sigma (DFSS) is a methodology of improvement that helps businesses create new products or services at a high level of quality. The technique aims to meet customer needs and utilize the company’s capability to reduce the need to redesign/reintroduce a product multiple times.

Topics:

1. What is Design for Six Sigma (DFSS)
   • Define, Measure, Analyze, Improve, and Control
2. Evaluating potential solutions
   • Experiments -Reasons and desired results
3. Design of Experiments (DOE)
   • Definition and goals
   • Post-pilot priorities
4. Verifying Results
5. Impact of process capability on cycle time and resource allocation
6. DFSS
   • What is it? Why use it?
   • Benefits
   • Tool Kit
7. Taguchi Loss Function - Taguchi Method
8. Toyota Production System (TPS): Two Pillars
   • Just-In-Time Production - Kanban System
   • Jidoka
9. Andon (status-display station)
10. Toyota Production System “House”
    • Standardized work, kaizen, plan-do-check-act (PDCA) cycle
11. Change management phases

Speaker:

Nick Vyas, EdD a practitioner in operations management and organizational excellence through the application of Blended Quality Management, AI, ML, RPA, Blockchain, and Data Analytics received his Doctor of Education from USC with his published dissertation on Conceptualization of Higher Education Excellence System (HEES): Use of Advance Data Analytics and Blended Quality Management. A Subject Matter Expert in End-to-End Global Supply Chain Management (GSCM), Dr. Vyas has led cultural and business transformation for fortune 100 companies. As USC Marshall Center for GSCM’s Executive Director / Co-founder, Director of MS GSCM and as an Assistant Professor, he was awarded with the Golden Apple Award for teaching excellence and recognized as a “Supply Chain Leader” for the APICS Excellence Awards. As a thought leader, he speaks at conferences sharing his views on global trade, disruptive technology and GSCM. Dr. Vyas serves to make GSCM education accessible through the Gift of Knowledge and Supply Chain Professionals Without Borders. nikhilvy@marshall.usc.edu

Audience:

This program is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO challenges.

Learner Level: Intermediate/ Advanced

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Credentialing Center’s Commission on Accreditation. Attendees to this CNE activity will be awarded 1.0 contact hours by ENPDC. No conflict of interest has been found with the speaker for this CNE activity nor with the members of the planning committee.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the fifth course in a five (5) session program. To complete the entire program and earn a badge CLICK HERE.