Discover Classes. Earn Rewards.

Design Control: Documentation, Implementation & Improve

at Quality & Productivity Solutions, Inc - Marlborough

Course Details
Price:
$595 15 seats left
Start Date:

Tue, Mar 03, 8:30am - 5:30pm

Location:
Marlborough
28 Lord Road, Ste 205
At Elm Street
Marlborough, Massachusetts 01752
(Map)
Share:
Purchase Options
Description
Class Level: All levels
Age Requirements: 18 and older
Average Class Size: 15

What you'll learn in this business training:

Design Control: Documentation, Implementation, and Improvement

This course has been designed to learn design control, design verification, design validation, Design History File (DHF), use concepts and implement, learn about planning (inputs/outputs), and risk analysis to ensure your organization\'s devices meet intended uses / user needs and specified requirements. Learn about control of design changes and their results as well as transfer (design to product manufacturing).

Course Benefits
Participants will understand FDA, design control, the life cycle of the product, the Design History File (DHF) and Device Master Record (DMR).

Who Should Attend?
The target audience for this course consists of managers and professionals work in quality (QA/QC), compliance / regulatory affairs, manufacturing (operations), or engineering (design).

Topics Covered:

  • Control of design in the Medical Device Industry
  • Design control process elements
  • ISO 9001vsISO 13485
  • The Design Control Team
  • Techniques for Design Verification & Validation
  • QSR
  • FDA Warning Letters related to design control
  • The content of design history file (DHF) & Device Master Record (DMR)
  • Process Model – approach to design control
  • Project Management: product life cycle in relation to design control
  • Exercises

Prerequisites:

Medical Device background, those in quality / regulatory affairs responsible for design control.

Please Note: Price includes materials, and certificate of attendance.

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.

Map

Google Map

Quality & Productivity Solutions, Inc

All classes at this location

Start Dates (1)
Start Date Time Teacher # Sessions Price
8:30am - 5:30pm TBD 1 $595

Benefits of Booking Through CourseHorse

Booking is safe. When you book with us your details are protected by a secure connection.
Lowest price guaranteed. Classes on CourseHorse are never marked up.
This class will earn you 5950 points. Points give you money off your next class!
Questions about this class?
Get help now from a knowledge expert!
Questions & Answers (0)

Get quick answers from CourseHorse and past students.

Similar Classes

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...

Read more about Quality & Productivity Solutions, Inc

CourseHorse Approved

This school has been carefully vetted by CourseHorse and is a verified Boston educator.

Ready to take this class?
BOOK NOW
Taking this class for work? Get exclusive perks & discounts for free.
Loading...