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Public webinars

Medical Device Process

Statistical Techniques for Process Validation - Made Easy

Part 1 of 2    Click here for Part 2 »

On-line webinar

Note. It is not a requirement to attend both PV webinars.

Course description:

The goal of these two webinars is demonstrate how valid statistical techniques contribute to Process Validation efforts. The application of valid statistical techniques is encouraged by the US FDA’s Quality System Regulation, cGMP, and ISO Standard 13485 for medical devices. The content reinforces the topics covered in the Process Validation Guidance document endorsed by the Global Harmonization Task Force (GHTF). Emphasis will be placed on best practices for quality systems in industry.

These fast-paced webinars will cover the details of application without the burden of statistical complexity. The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do not need to have a background in statistics.

While most webinars cover the “What and Why” for a subject, these webinars will also give ideas on the “How To” for valid statistical techniques. This “How To” will cover actual examples of application and discuss methods for writing protocols and reports. The discussion of documentation is especially important for FDA-regulated companies.

You will hear directly from an industry expert on this important topic and you can ask questions and get answers. The presenter has over 20 years of experience helping a broad variety of firms apply statistical tools and techniques .

Program overview

  • Explore valid statistical techniques for Process Validation
  • Provide a mapping of tools and techniques to IQ, OQ and PQ activities
  • Provide examples of industry best practices in each area
  • Discuss options for documentation
  • Demonstrate how these tools support regulatory compliance, especially if mandatory or voluntary action is required

Program-at-a-glance - Part 1

  • Setting the Stage for FDA-requirements and expectations
  • Test Method Validation for IQ
  • Exploring Historical Data for OQ
  • Process Capability Measures for OQ & PQ
  • Question and Answer Period

Who should attend:

This material will appeal to quality professionals and managers in large and small companies.
Instruction is targeted to: quality engineers, process & manufacturing engineers, regulatory compliance professionals, and members of the leadership team.


There are no prerequisites for these webinars. No background in statistics is necessary. That is the foundation of our "keep-it-simple" approach.



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Watch this short video to learn more about what Gate2GMP® offers »


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Course facts

Course no:
Medical Devices

CS region:

Peter Knepell
Peter Knepell, PhD
President, Peak Quality Services

27 January 2020

14.30 - 16.30 (120 min) CET (Central European Time)

Price (excl. local VAT):
250 Euro for the first participant.
115 Euro for the following participants on the same registration and invoice.
Course handouts (PDF) and certificate of attendance is included.
For larger groups, please contact us for an offer.

Need of equipment:
You need access to a computer, tablet or mobile phone with internet connection (preferably min 700kB/s) and audio capabilities (speakers or headphones).
We are using the easy to use application "GoToWebinar".
See more about how to join a session and the system requirements here »

Instructions will be attached to your order confirmation.

Cancellation policy for webinars:
Cancellations received less than 24 hours before the webinar will be charged 50% of the course fee.

If you for any reason is unable to attend, substitution is always possible and preferred. All cancellations and/or substitutions must have been communicated with and confirmed by us.

In case of failure to cancel before the course, the course fee will be charged in full.

Cancellation of webinars:
Courses may be cancelled by the organizer if bookings fail to reach minimum numbers. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value.