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GMP/ISO System Documentation

at Quality & Productivity Solutions, Inc - Marlborough

Course Details
Price:
$995 15 seats left
Start Date:

Wed, Dec 04, 8:30am - Dec 06, 5:30pm (3 sessions)

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: 15

What you'll learn in this business training:

This course has been designed to learn add value to your company’s QMS by effectively and efficiently deploying GMP/ISO documentation (required documents, levels, etc.)

Course Benefits
Participants will understand ISO documentation, its requirements, process mapping / flowcharting, and Standard operating procedures (SOPs) / System-level procedures (SLPs).

Who Should Attend?
The target audience for this course consists of quality, engineering and manufacturing who are involved in the development, implementation and use of GMP / ISO Documentation.

Topics Covered

  • Introduction / Background
  • Definitions / terms
  • GMP / ISO
  • Standard operating procedures (SOPs)
  • System-level procedures (SLPs).
  • FDA: regulations / standards.
  • Job Instructions
  • Required Documentation: document control, how to document, all levels of documentation
  • Procedural requirements
  • Corrections
  • Flowcharting
  • Process mapping / maps
  • Checklist
  • Forms
  • Management System (structure)
  • Exercises
  • Workshop

Prerequisites: GMP / ISO background

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.

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Quality & Productivity Solutions, Inc

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Start Dates (1)
Start Date Time Teacher # Sessions Price
8:30am - 5:30pm TBD 3 $995
This course consists of multiple sessions, view schedule for sessions.
Thu, Dec 05 8:30am - 5:30pm TBD
Fri, Dec 06 8:30am - 5:30pm TBD

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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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