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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

Process Validation Training for Medical Devices:
Principles and Protocols

The FDA and ISO 13485:2016 require process validation, but don’t offer much guidance. Over 3 days of interactive discussions and workshops, you’ll take a simple process through the entire validation cycle – writing protocols, determining key operating parameters, and identifying data analysis strategies. You will learn how to interpret the regulations, standards, and guidance documents; correctly apply the principles of risk management; create qualification protocols (IQ, OQ, PQ); and identify statistical methods and tools when implementing and maintaining process validation activities.

You’ll also evaluate real-world process validation examples and warning letters, as well as learn best practices for the practical application of process validation in medical device manufacturing.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
San Francisco Area, CA 08/13/2019 3 $2895.00 Add to Cart CONTACT US
Orlando, FL 09/10/2019 3 $2895.00 Add to Cart CONTACT US
Minneapolis, MN 10/01/2019 3 $2895.00 Add to Cart CONTACT US
San Diego, CA 10/22/2019 3 $2895.00 Add to Cart CONTACT US
Boston, MA 11/12/2019 3 $2895.00 Add to Cart CONTACT US
Chicago, IL 12/03/2019 3 $2895.00 Add to Cart CONTACT US

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Explain the purpose of process validation, understand its life cycle, and describe key concepts needed to successfully conduct process validations.
  • Identify the available guidelines and sources of requirements.
  • Create a validation master plan (VMP).
  • Explain the intent of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
  • Describe the requirements for IQ, OQ, and PQ and create associated protocols.
  • Identify and manage sources of variation in measurement systems.
  • Articulate the role of quality management systems, metrology and measurements systems, risk management, and quality tools and analysis in process validation.

Who Should Attend

Recommended for quality, regulatory, engineering, manufacturing, and other technical professionals who plan, execute, report, maintain, review, or manage process validation activities, and who have basic knowledge of statistics or statistical tools. 

Number of Days: 3
CEUs: 2.5
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Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

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