Post on 22-Jan-2018
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Sheridan Engineering Sciences and Technology Program Presentation
David Cooper
December 9-2015
CourseProgramMock
SKILLSOPTIONS
PRESENTATION
Course SKILLS
Health-Tech Program
Course Skills
Program Options
Mock Presentation
Medical Devices QA & RA Course – Leadership/People Skills
Course Skills
Program Options
Mock Presentation
Over 25 years of direct Healthcare Sector Medical Device experience in various roles provides the following skills and competencies…
• Strong Technical and Collaboration skills partnering with QA/RA Leadership Teams.
• Exceptional Customer Service proficiencies balancing regulatory needs with company sales and customer expectations.
• Direct responsibility and leadership on internal and external Customer Service regulatory audits including creating and training of processes.
• Strategic Management and Oversight of all Healthcare Customer Service CAPA’s including Coaching the teams on process and communications.
Medical Devices QA & RA Course – Functional/Technical Skills
Course Skills
Program Options
Mock Presentation
Over 25 years of Corporate experience and training in various roles as well as my entrepreneurial experience in Professional Organization and Technology provides the following skills and competencies…
• Strong Time management and prioritization skills
• Excellent Presentation Skills
• Critical Thinking and Analytical competencies (strong YELLOW– 4D-i)
• Positive Personal Spirit (4D-i)
• “Quest” for Learning and Teaching
• Networking and Collaboration Skills (both live and online)
• Change Management (“Heart of Change”)
Mock Presentation
Program Options
Course Skills
Telemedicine Program
Program OPTIONS
Medical Device QA & RA Course Module Ideas…
Course Skills
Program Options
Mock Presentation
• Root Cause Investigation
• RCA Tools – Mind Mapping, 5 WHY’s, Fishbone, Pareto Chart, etc.
• Teamwork and Collaboration
• Effective Communication Skills
Other Healthcare Continuing Education Course Ideas…
Course Skills
Program Options
Mock Presentation
• Healthcare Customer Service and Support
• Telemedicine Technology Solutions (Hardware/Software)
• Medical Equipment Installations
• MEDEC (Humber College)
• Biomedical (Durham and Centennial College)
• Healthcare Technology Innovations (Microchip Modelling, Telemedicine Google Glass and Facetime, 3D Printing, OptoGenetics, Hybrid OR’s, Digestible Sensors, Cloud Software Solutions, Nanobots, The Hospital Experience (Ottawa Hospital), Robotic “Flight Simulator” Surgery, Holographic Images, Stem-cell Reconstructive Surgery, Augmenting Human Capabilities)
Manufacturing Leadership Certificate (MLCP) Program
Mock Presentation
Program Options
Course Skills
Mock Guest Speaker Presentation
CAPA
Mock Presentation
SimpleTo Reach
Course Skills
• WHAT is CAPA?• Corrective Action and Preventive Action
• WHY does a Medical Device organization require this?
• WHO does this impact?• HOW is this implemented?
“This course emphasizes the importance of QA and RA building effective communication relationships with internal stakeholders, suppliers and regulatory officials. Students apply a strategic, risk based approach to position QA and RA as enablers of business objectives in a medical devices organization, while minimizing productivity loss and without compromising device safety, effectiveness or regulatory compliance.”
CAPA – Case Study @ Philips Healthcare
Mock Presentation
SimpleTo Reach
Course Skills
• A successful CAPA strategy is more cultural than technical
• A complaint root cause investigation process is paramount
• Teamwork is critical…companies have trouble �breaking down the silos across departments
• Training and education is key at all levels of the organization
• Ensure your people in the organization can commit to the process…and then do what you said you will do
2015 Sample Case Studies…
Mock Presentation
Program Options
Course SkillsIt’s the processes and the people – that ultimately affect
product quality…..
CourseProgramMock
SKILLSOPTIONS
PRESENTATION
In summary…
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