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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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