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Auditing to ISO 13485/FDA QSR

at Quality & Productivity Solutions, Inc - Marlborough

(22)
Course Details
Price:
$1,495
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Location:
Marlborough
28 Lord Road, Ste 205
At Elm Street
Marlborough, Massachusetts 01752
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Description
Class Level: All levels
Age Requirements: 18 and older
Average Class Size: 8

What you'll learn in this audit class:

This course has been designed to help you understand the requirements for auditing to ISO 13485 and FDA QSR. Understand the requirements of the auditing process; planning, auditing and reporting and follow up.

Course Benefits:

Participants will learn ISO 13485 standard in details, understand how to develop a checklist, plan and execute the audit. Furthermore, they will also acquire knowledge on FDA inspection processes and procedures.

Topics Covered:

  • Principles of quality management
  • Auditing process
  • ISO 13485 requirements and evidence requirements
  • Developing audit checklist and documentation
  • FDA perspective on the audit
  • FDA inspection process
  • Inspection report and analysis
  • Conducting the audit
  • Developing the audit report
  • Corrective Actions and Root Cause Analysis
  • Improving the system
  • Who Should Attend?
  • Anyone interested in learning ISO 13485 standard/ FDA QSR and how to audit and improve their QMS.


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Refund Policy
REFUND POLICY: (AS PER M.G.L. CHAPTER 255, SECTION 13K)
  1. You may terminate this agreement at any time.
  2. If you terminate this agreement within five days you will receive a refund of all monies paid, provided that you have not commenced the program.
  3. If you subsequently terminate this agreement prior to the commencement of the program, you will receive a refund of all monies paid, less the actual reasonable administrative costs described in paragraph 7.
  4. If you terminate this agreement during the first quarter of the program, you will receive a refund of at least seventy-five percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  5. If you terminate this agreement during the second quarter of the program, you will receive a refund of at least fifty percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  6. If you terminate this agreement during the third quarter of the program, you will receive a refund of at least twenty-five percent of the tuition, less the actual reasonable administrative costs described in paragraph 7.
  7. If you terminate this agreement after the initial five-day period, you will be responsible for actual reasonable administrative costs incurred by the school to enroll you and to process your application, which administrative costs shall not exceed fifty dollars or five percent of the contract price, whichever is less. A list of such administrative costs is attached hereto and made a part of this agreement.
  8. If you wish to terminate this agreement, you must inform the school in writing of your termination, which will become effective on the day, such writing is mailed.
  9. The school is not obligated to provide any refund if you terminate this agreement during the fourth quarter of the program.

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School: Quality & Productivity Solutions, Inc

Quality & Productivity Solutions, Inc

Quality & Productivity Solutions, Inc. is an international firm dedicated to providing practical and effective consulting and training to achieve client objectives. Whether it’s improvement in process, product, service, or overall performance, exceptional results are our business. We partner with...

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