Discover Classes. Earn Rewards.

Process Validation is unfortunately unavailable

Thankfully we have 2 other Medical Classes for you to choose from. Check our top choices below or see all classes for more options.

Lean Six Sigma Black Belt Certification

Six Sigma Development Solutions, Inc. @ 100 Boardman Street, Boston, MA & Virtually Online

The Lean Six Sigma Black Belt certification course is full of games, videos, and other active learning. We will be using simulations to learn the importance of data and statistics when solving a process problem. At the end of the course, the Master Black Belt Instructor will give you the tools to complete your Six Sigma Black Belt Certification project quickly and effectively.

(1) Intermediate 21 and older
$2,999

5 sessions

Gift it!

Lean Six Sigma Green Belt Certification

Six Sigma Development Solutions, Inc. @ 100 Boardman Street, Boston, MA & Virtually Online

The Lean Six Sigma Green Belt course has games, videos, and other active learning. We will be using simulations to learn the importance of data and statistics. You will learn powerful root cause analysis tools as well as using Minitab as a statistical analysis tool throughout the course. At the end of the course, the Master Black Belt Instructor will give you the tools to complete your Six Sigma Green Belt Certification project quickly and effectively.

(1) Intermediate 21 and older
$2,999

5 sessions

Gift it!
See all Medical classes Boston

Process Validation

Gain a comprehensive understanding of process validation concepts for medical devices and pharmaceutical products. Master the skills necessary to validate processes with this course offered by Quality & Productivity Solutions, Inc.

  • All levels
  • 18 and older
  • $1,095
  • 28 Lord Road, , Marlborough, MA
  • 18 hours over 2 sessions

Start Dates (0)

  • $1,095
  • QPS @ 28 Lord Road, Ste 205, Marlborough, MA 01752
  • 18 hours over 2 sessions
Showing 10 of 0

Class Description

Description

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.

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.
In any event where a customer wants to cancel their enrollment and is eligible for a full refund, a 5% processing fee will be deducted from the refund amount.

Reviews of Classes at Quality & Productivity Solutions, Inc (1)

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 10950 points. Points give you money off your next class!

Questions & Answers (0)

Get quick answers from CourseHorse and past students.

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.

Quality & Productivity Solutions, Inc

Quality & Productivity Solutions, Inc

All classes at this location

Google Map

Give This Course as a Gift Card

  • Thousands of classes
  • No expiration
  • Unique and memorable gifts for any occasion
  • Personalized
  • Explore a passion, gain a new skill, discover a new hobby, engage in a memorable experience
  • Instant delivery
  • Lock in a price with the Inflation Buster Gift Card Price Adjuster™

Buy a Gift Card

Book this Class as a Group Event

Booking this class for a group? Find great private group events

Or see all Professional Group Events

Explore group events and team building activities ranging from cooking, art, escape rooms, trivia, and more.

CourseHorse Gift Cards

  • Creative & unique gift for any occasion
  • Thousands of classes & experiences
  • No expiration date
  • Instant e-delivery (or choose a date)
  • Add a personalized message
  • Lock in a price with the Inflation Buster Gift Card Price Adjuster™
Buy a Gift Card
gift card with the CourseHorse logo gift card with the CourseHorse logo
Loading...