Medical Devices Regulations/QSR

at Quality & Productivity Solutions, Inc - Marlborough

Course Details
Price:
$1,295 15 seats left
Start Date:

Thu, Aug 20, 8:30am - Aug 21, 5:30pm Eastern Time (2 sessions)

Next start dates (1)

Location:
Marlborough
28 Lord Road, Ste 205
At Elm Street
Marlborough, Massachusetts 01752
(Map)
Important:
Price includes materials, class supplies.
Description
Class Level: All levels
Age Requirements: 18 and older
Average Class Size: 10

What you'll learn in this medical training:

This course has been designed to help you understand the Quality System requirements including FDA perspective and how to implement.

Course Benefits

Participants will understand the QSR, FDA requirements and how ISO 9001 and QSR can be deployed.

Topics Covered:

  1. What are QS Regulations
  2. The FDA Philosophy
  3. Medical Device Overview
  4. Relationship to ISO standards
  5. The Quality System Regulations
  6. Quality Records
  7. Regulatory Requirements and FDA expectations
  8. Impact of QS Regulations on other industries
  9. The Quality System Inspection Technique
  10. Design Controls Understanding Medical Devices Regulations

Who Should Attend?

Individuals interested in learning the Medical Device Regulations which includes engineers, quality professionals, auditors, managers etc.


Remote Learning

This course is available for "remote" learning and will be available to anyone with access to an internet device with a microphone (this includes most models of computers, tablets). Classes will take place with a "Live" instructor at the date/times listed below.

Upon registration, the instructor will send along additional information about how to log-on and participate in the class.

Still have questions? Ask the community.

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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Quality & Productivity Solutions, Inc

All classes at this location

Start Dates (2)
Start Date Time Teacher # Sessions Price
8:30am - 5:30pm Eastern Time TBD 2 $1,295
This course consists of multiple sessions, view schedule for sessions.
Fri, Aug 21 8:30am - 5:30pm Eastern Time TBD
8:30am - 5:30pm Eastern Time TBD 2 $1,295
This course consists of multiple sessions, view schedule for sessions.
Fri, Oct 16 8:30am - 5:30pm Eastern Time TBD

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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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