Wrapping up our series on Medical Device Process Validation, Josh and Keith discuss the meat of the final step: Performance Qualification.
Writing Operational Qualification (OQ) protocols? In this episode, Keith and Josh walk through elements of an operational qualification protocol template!
While we all wish operations and suppliers were perfect, nonconforming material is a typical part of daily work for any quality professional. In this article, we’ll discuss the risk associated with the various dispositions for nonconforming material, and some expectations for each of the dispositions.
We will start with the lowest risk, and then work our way up the scale to the highest risk disposition for nonconforming product.
In Episode 1, Keith and Josh discussed a general overview of Process Validation. In this Episode, they dive into the first step in Process Validation: Installation Qualification.
Have a question on this episode? Contact Us with your question, comment below, or find us on Twitter @AppliedQARA and we may answer it on air!
In this episode, we have a general discussion about process validation – what it is, why we do it, and a general overview of Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ).
Have a question on this episode? Contact Us with your question, and we may answer it on air!
Getting a new podcast off the ground takes a considerable amount of effort and support, and I want to take a moment to thank those that have helped launch the Applied QA/RA podcast:
Stone House Recording in Grand Rapids, Mi
Stone House Recording was willing to work with us, giving us studio time and editing at a fair rate for Saturday mornings (we work during the week), and we really appreciate all of their help. Without them, this podcast would not have gotten off the ground – very cool.
BarbarAdWriter at Fiverr.com
The sweet podcast cover art that we use was made by barbaradwriter at Fiverr.com, and it only cost $6 (of which they clear like $3). Big shout out to all of those that help us bootstrap up this podcast for low cost.
The podcast intro with the sweet guitar baseline is courtesy of this site. Thanks for getting us off to a rocking start!