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Public webinars

Control Charts

Applying Control Charts for Visualizing and Detecting Trends

Online webinar - 8 June 2020


Course description:

Have you ever accused your associates of over-reacting to the slightest changes in production, corrective actions, complaint monitoring, or servicing? Or worse yet, have folks in your organization over-looked obvious trends in those key areas? This webinar will provide a valid statistical procedure that is so simple, you won’t even know that you are applying statistics -- all the time. Statistical process control (SPC) charts are highly graphical tools applied in world-class organizations.

Applying SPC charts are invaluable for detecting trends in Process Validation, CAPA, complaint monitoring, technical support issues, and product servicing. This graphical tool is a very efficient way to present data on the front lines and at management reviews. FDA regulatory requirements and the recommendations of the guidance documents developed by the FDA and the Global Harmonization Task Force (GHTF) will be discussed. Best practices applied in a wide variety of industry settings will be illustrated.

This webinar will cover the details of application without the burden of statistical complexity. Analysis results from popular statistical software programs will be illustrated. The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do not need to have a background in statistics.

Program objectives

At the end of this webinar, participants will be able to:

  • Describe the statistical background for control charts
  • Apply Statistical Process Control (SPC) charts in a variety of settings
  • Know how to select the appropriate SPC chart given the intended use
  • Discuss how FDA regulatory and ISO requirements are satisfied using SPC charts

Program-at-a-glance

  • Background
    • Decision Making and Assessing Risk
    • Statistical Concepts
    • Applying SPC charts to Detect Trends
  • Selection & Demonstration of Five Popular SPC Charts
    • Scenario & Appropriate Chart
    • Interpreting Charts
    • Statistical Software Output
    • Other Considerations
  • Regulatory and Other Considerations
    • US FDA Quality System Regulation
    • ISO 13485
    • GHTF Guidance on Process Validation
    • Warning Letters
  • Wrap Up and Q&A
    • Key Takeaways
    • Important Considerations for Application
    • Q&A

Who should attend:

This webinar is targeted to professionals concerned with the application of Sampling Plans to meet the requirements of the FDA's Quality System Regulation. The content should have great value to individuals in industry and the FDA who are involved with: new product development; process development; manufacturing, process, and quality engineering; operations; quality assurance; quality control; and regulatory compliance. Through this overview of sampling, managers and members of the leadership team would see how value is added to a product or process.

Prerequisites

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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Course facts

Course no:
5817
Industry:
Medical Devices

Level:
Basic/Intermediate
CS region:
Global

Language:
English
Instructor:
Peter Knepell
Peter Knepell, PhD
President, Peak Quality Services

Date:
8 June 2020


Time:
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.


Equipment needed:
You need access to a computer, tablet or mobile phone with internet connection (preferably min 1MBit/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 7 days before the webinar will be charged 50% of the course fee.
Cancellations received less than 24h before the webinar will be charged 100% 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.