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Course Details
Price:
$995
Start Date:

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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: 10

What you'll learn in this medical training:

This course has been designed to help you understand the process validation concepts for medical devices and pharmaceutical products. This also covers the following:

  • Determining which process must require validation
  • Evaluate if the process is capable
  • Monitors and controls for the process
  • Statistical methods
  • Software qualifications

Course Benefits

Participants will understand the validation process and master skills necessary to validate processes.

Topics Covered:

Module 1 – Validation Concepts, Terms, and Definitions

  • Understand the basic concepts of process validation, including the need to validate
  • Identify conditions when process validation is required
  • State the QSR definition of process validation
  • Compare and contrast process output verification with process validation
  • Describe additional process requirements for validated processes
  • Compare and contrast IQ, OQ, and PQ

Module 2 – The Requirements Framework

  • Understand the requirements framework from FDA, ISO 13485, and OSHA
  • State the requirements for process validation from the FDA QSR
  • State the requirements for process validation from ISO 13485
  • Explain the relationship between process validation and a) medical device reporting, b) corrections & removals, and c) risk management
  • Identify the guidance documents published by FDA that relate to process validation
  • Explain the role of sampling in determining the need for process validation
  • Compare and contrast Lock Out – Tag Out with Machine Guarding

Module 3 – Process Validation Approaches

  • Module 3.1 – Example
  • Understand the typical approaches to process validation, the approaches that generated them, and a unified approach to implementation
  • Compare and contrast the QSR and ISO 13485 requirements for process validation
  • Define subsequent verification and its role in process validation
  • Compare and contrast prospective, concurrent, and retrospective validation
  • Compare and contrast installation, operational, and performance validation
  • State the five interlocking parts of validation
  • Explain the four process steps for each part

Module 4 – Installation Qualification

  • Understand the elements typically included in Installation Qualification (IQ)
  • Define Installation Qualification and describe its role
  • State the QSR requirements for maintenance and describe how IQ contributes to conformity
  • State the QSR requirements to post inherent limitations or allowable tolerances for equipment
  • Identify the source for maintenance information
  • State why you should identify all energy sources

Module 5 – Statistical Methods & Exercises

  • Review three common statistical approaches required for process validation
  • Review the process capability indices Cp and Cpk
  • Review the fundamentals of the x-bar & R chart
  • Review the concepts of designed experiments, both full and fractional factorial

Module 6 – Operational Qualification

  • Understand the purpose and role of Operational Qualification in Process Validation
  • Compare and contrast the FDA and GHTF definitions of Operational Qualification
  • State the source of production specification in the QSR
  • Describe challenge tests and their role in Operational Qualification
  • Explain how challenge tests can be related to designed experiments

Module 7 – Performance Qualification

  • Understand the purpose and role of Performance Qualification in Process Validation
  • Compare and contrast the FDA and GHTF definitions of Performance Qualification
  • Explain how performance monitoring can be related to statistical control methods
  • Explain the role of action limits in performance monitoring

Module 8 – Software Qualification

  • Understand the QSR and ISO 13485 requirements for software
  • State the QSR requirements for production software
  • State the ISO 13485 requirements for software used in production or service provision
  • Describe the requirement for software validation in embedded systems in production equipment
  • Part 11 requires validation of software used in electronic records or electronic signatures

Who Should Attend?

Individuals interested in learning how to conduct process validation, including engineers, managers, and project leaders.

Please Note: Price includes materials, certification.

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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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