Validation Sampling Plans and Setting Acceptance Criteria

Live Webinar
Date: Thursday February 21, 2019
Time: 11:00 AM ET | 8:00 AM PT
Duration: 90 mins with Q&A

Share on: Linked In  |  Facebook   |  Twitter

This webinar will describe How to set up sampling plans for process validation and how to determine appropriated acceptance criteria for both process and test method validation protocols. It will also cover use of statistical process controls to maintain a validated state.

Areas Covered During The Session

  • What is Sampling
    • Sampling is the ability to make a quality determination on a large number of things without direct examination of each thing
  • Validation Sampling
    • Not the same as lot acceptance sampling
    • Differences
  • Setting up a Validation Sampling Plan
    • Five step method
  • Using sampling plans to set acceptance criteria for process validation
  • The concept of Acceptance Criteria in Test Method Validation
    • Variance, how much is too much
    • How to measure variance and why
  • Use of Process Capability
    • The concept of process capability
    • Cp vs CpK
    • How to use process capability to set acceptance criteria for test method validation
  • Statistical Process Controls

Alan Golden, Principal, Design Quality Consultants, LLC

Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.

Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.

Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.

Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.

Why you should attend the session

Obtain a basic understanding behind setting up statistically valid sampling plans based on product risk and design stage. Learn practical ways to set up statistically justified acceptance criteria.

Who should attend
Personnel involved in process and test method development, Quality Operations, Manufacturing, Engineering, Facilities and equipment qualification, and process development.

Register Today!

 

Single Registration
Single Attendee: $208.00 + HST CAD per session
Single attendee refers to single participant at a single computer/login.


Group Registration
Group of 5 or less per location: $518.00 + HST CAD per session
Group of 6 to 10 attendees per location: $768.00 + HST CAD per session
Group of 11 to 20 attendees per location: per location: $1250.00 + HST CAD per session

Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.


Please contact us at enquiry@ipacanada.com for any other enquiries.