"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Public webinars

Medical Device Process

Statistical Techniques for Process Validation - Made Easy

Part 1 of 2    Click here for Part 2 »

Recorded webinar
Completed 22 March 2019. Available as streamed video.

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.

Prerequisites

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

 

Gate2GMP®

Get FREE access to Gate2GMP®, our document library and search tool.
Watch this short video to learn more about what Gate2GMP® offers »

 

Bring this course in-house?

Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?

 If so, running the course in-house is probably the best and most cost effective solution.

Make an enquiry

 

Order recording  

 

Course facts

Course no:
5806
Industry:
Medical Devices

Level:
Basic/Intermediate
CS region:
Global

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

Date:
Recorded 27 January 2020.

Order recording


Time:
120 min

Price (excl. local VAT):

Recording: 250 Euro
The video is available for 30 days.
Course handouts (PDF) included.
No certificate.


How to access the video:
You will receive a private link by email to the video at Vimeo.com. The video can only be streamed online (not downloadable).