This event is cancelled or expired.
Jul
2017
Quality Management Systems Lead Auditor Training, Incorporating ISO 13485:2016 and MDSAP Requirements (CQI/IRCA Certified*)
United States, Reston
17 Jul 2017 - 21 Jul 2017
Entrance: $2,695.00 (excl.VAT)
Lunch:
included
10% discount for companies registering 5 or more students
Start : Monday, 8:00 AM
End : Friday, 5:00 PM (GMT)
Course overview:
This five-day course provides the skills and knowledge that have taken many experienced auditors decades to develop. During the course, you will plan and prepare audits based upon case studies that simulate both supplier and third-party audits utilizing the MDSAP audit requirements. Throughout the course, you will participate in simulated auditing exercises that include planning, preparation and evaluation of audit evidence. You will also practice the application of ISO 13845:2016 and the MDSAP requirements. Students will be assessed throughout the course and an exam will be administered on the final day.
Who should attend:
This course is vital for medical device quality professionals with responsibility for conducting or implementing internal audits, supplier audits, corporate audits or third-party audits. Quality directors, regulatory managers and those responsible for managing internal, corporate, supply chain or registration audit programs will also benefit from this course.
Registration fee includes:
- All resource material
- All training materials
- ISO 13485:2016 Medical Device QMS Standard (hard copy)
- Final Exam Administration
- Certificate of Completion* (with Passing exam score of 70% or above)
- Lunch daily
Location:
Reston Town Center
1818 Library Street
Suite 500
Reston, Virginia 20190
United States
Registration contact:
Click Here to Register or Visit: https://www.regonline.com/builder/site/Default.aspx?eventid=1963187
Phone: 202-822-1850
Email Us
If you want to proceed to the registration later : You can create a personal account on biopharma-training.com. Then you can add this training to your space and contact NSF in time by using their electronic formular or a direct e-mail to our marketing contact.
Learning oucomes:
After completing this course, you will understand how to :
- Plan, conduct, report and follow up on a QMS audit in accordance with ISO 19011, ISO 13485:2016 and MDSAP
- Apply the MDSAP audit strategies adopted by Auditing Organizations in the MDSAP program
- Identify nonconformities, grade nonconformities and prepare an audit report in accordance with the MDSAP criteria
Prerequisites:
Students must have prior knowledge of the following concepts :
- The plan, do, check, act (PDCA) cycle in the context of processes
- The structure, content and requirements of ISO 19011 and ISO 13485:2016
- The relationship between quality management and regulatory compliance
- Regulatory requirements of at least one MDSAP participating country or the EU
- Commonly used terms and definitions and the seven quality principles of ISO 9000
- The process approach used in quality management
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James Pink
MCQI, CQP
Instructor
Resume
James Pink has over 20 years of experience in the medical device industry, which includes auditing medical device manufacturers worldwide (formerly for the British Standards Institute), as well as managing development and quality assurance programs for the orthopedic, cardiovascular and dental sectors. He has been providing training and education globally on medical device technologies, quality systems and auditing for over 15 years.