5. 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.
6. 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”)
9. 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
10. 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)
13. CAPA
Mock
Presentation
Simple
To 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.”
14. CAPA – Case Study @ Philips Healthcare
Mock
Presentation
Simple
To 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
15. 2015 Sample Case Studies…
Mock
Presentation
Program
Options
Course
Skills
It’s the processes and the people – that ultimately affect
product quality…..
A successful CAPA is more cultural than technical
When I took over the leadership of the Customer Support and Business Operations at Philips Healthcare Customer Service in March 2011, there were 4 Installation related aging CAPA’s (Installation Site Audits, Installation IATD’s, Installation Test Equipment Records, Installation Service Work Orders).
The Installation process was broken and the installers in the field were not involved, educated or mandated to go by the processes…it was not in their CULTURE!
A complaint root cause investigation process is paramount
1. Identify…the problem.
2. Evaluate…its magnitude, which includes assessing risk.
3. Investigate…and assign responsibility.
4. Analyze…and document the root cause of the problem.
Teamwork is critical - companies have trouble breaking down the silos across departments
One process could touch over 10 departments – service, sales, logistics, order management, order fulfillment, Call Center, etc..
Training and education is key at all levels of the organization…and to identify the reason WHY
The WHY or WIIFM is critically important to us all. “Why am I being asked to do this training and What’s in it for me”? In this case, although it was known that if QUALITY ISSUES are not resolved then the organization could face fines, sanctions, credit rating, potentially lose their license… but it needed to be personal (sales, personal job loss).
Ensure the people in the organization can commit to the process…and then “do what has been documented”
Don’t assume that a chosen few can represent the masses. Involve the stakeholders and subject matter experts. This ensures that the processes are realistic and achievable.
If it is a company process, procedure or policy, then you have to do it.
A successful CAPA is more cultural than technical
When I took over the leadership of the Customer Support and Business Operations at Philips Healthcare Customer Service in March 2011, there were 4 Installation related aging CAPA’s (Installation Site Audits, Installation IATD’s, Installation Test Equipment Records, Installation Service Work Orders).
The Installation process was broken and the installers in the field were not involved, educated or mandated to go by the processes…it was not in their CULTURE!
A complaint root cause investigation process is paramount
1. Identify…the problem.
2. Evaluate…its magnitude, which includes assessing risk.
3. Investigate…and assign responsibility.
4. Analyze…and document the root cause of the problem.
Teamwork is critical - companies have trouble breaking down the silos across departments
One process could touch over 10 departments – service, sales, logistics, order management, order fulfillment, Call Center, etc..
Training and education is key at all levels of the organization…and to identify the reason WHY
The WHY or WIIFM is critically important to us all. “Why am I being asked to do this training and What’s in it for me”? In this case, although it was known that if QUALITY ISSUES are not resolved then the organization could face fines, sanctions, credit rating, potentially lose their license… but it needed to be personal (sales, personal job loss).
Ensure the people in the organization can commit to the process…and then “do what has been documented”
Don’t assume that a chosen few can represent the masses. Involve the stakeholders and subject matter experts. This ensures that the processes are realistic and achievable.
If it is a company process, procedure or policy, then you have to do it.
