B Christine Park's Page

A Subject Matter Expert (SME) or domain expert is a person who is an expert in a particular area or topic. When faced with the FDA or another regulatory agency, we tend to call on SMEs that are most intimate or familiar with the details of the process or product in question. In some cases, we reach too deeply into the organization to an individual that has comprehensive knowledge of technical/processes, but not effective at explaining this information. Thus, we open the door to unnecessary…

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During one of my early inspection experiences with the FDA,  I found myself working with a team who felt they didn’t need a backroom setup to review documents prior to bringing them to the investigator.  Naively, I agreed to let the team move forward with the inspection. As the observer, I watched as things spiraled out of control.



The investigator requested a specific document which was brought into the room. During the review, the investigator asked to speak to the individual…

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When was the last time an inspector from the FDA

showed up at your site? While many FDA inspections are scheduled with some

advance notification, there is always a possibility that an inspector from the

Agency could show up at your door any time. Are you prepared?

It is a standard practice to have a Standard

Operating Procedure (SOP) defining what your organization should do when the

FDA (or other government agency) shows up at your site. Some of…

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Do we really need process validation?   ABSOLUTELY!

My last blog on design verification and validation triggered a lot of comment and response. In fact, some of you started bringing process validation into the discussions. Related to FDA definitions of terms, 21 CFR 820 defines process validation as:



“(z)Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be…

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