2022 - Validation Sampling Plans

OVERVIEW
This webinar will discuss setting up statistically justified sampling plans for process validation. The discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.
WHY SHOULD YOU ATTEND?
All companies in the pharmaceutical and medical device space are required to implement formal and statistically justified sampling plans and acceptance criteria for validation. Many companies do not have dedicated statistics departments, so it is up to the validation or quality engineer to develop sampling plans. This training will be a simple step-by-step method of developing statistically justified sampling plans and acceptance criteria.
This webinar will discuss methods for setting up sampling plans depending on the risk profile of the final product or production step. It will go into using the sampling plan to set statistically justified acceptance criteria for the validation. Also presented will be setting confidence levels and spreading that confidence level out over multiple runs. Setting statistically justified acceptance criteria for test method validation will also be discussed.
AREA COVERED
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
Pre-Sampling Determinations
Steps to setting up sampling plans
Variables vs Attributes Sampling Plans
The concept of Acceptance Criteria
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
WHO WILL BENEFIT?
QA professionals
Technical scientists
Production staff
Statisticians involved in validation
from Medical Device and Pharmaceutical Companies
SPEAKER PROFILE
Alan M Golden 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.
For more detail, please click on this below link:
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Email: info-AT-247compliance.us
Tel: +1-661-336-9555
https://www.linkedin.com/in/whitney-jones-87357317...