Welcome!
Quality Driven,
Excellence Delivered.
This is the second in a series of posts that I’m writing to fully explain the “new” Competency Testing in Aseptic Manipulation assessment in the latest revision to USP <797>. In this article we’re going to talk about media fills. This always seems to be a topic that people scratch their hands and ask, “should […]
I have had many people ask about USP Chapter <797>’s “new” Competency Testing in Aseptic Manipulation. Why do I put “new” in quotes? The truth is, this actually isn’t necessarily new. It is the way this should have been performed all along. USP has done a much better job of spelling this out for sure. […]
When the U.S. Food and Drug Administration (FDA) conducts an inspection of a pharmaceutical facility, they might issue a Form 483 if they observe any conditions that, in their judgment, may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related laws. Receiving a Form 483 can be concerning for a pharmaceutical company, […]
I’m not sure why this is but USP’s Chapter <797> section on Quality Assurance and Quality Control (QA/QC) has always been almost like an afterthought. It’s at the very end of the chapter and doesn’t take up much space. The revision coming in November follows suit with previous iterations. Quality Assurance, just one person’s opinion, […]
About
Can we be your guide?
The great aim of eduation is not knowledge but action. If you have been led down the wrong road, you don’t need motivation or encouragement, just the right information to put you on the right path. Compliance is not a one time event, but a continuous (and ever changing) process. Sometimes all we need a little help (or a lot); to get our operations producing quality above and beyond what we could have ever imagined. Let us help you get there.
What we do
Consulting Services
Remote Consulting
This option is for anyone of course, but saves on travel - just about anything on-site, I've figured out a way to do remotely. However, if needed more than willing to come to you!
Operations Analysis
Need a second set of eyes from outside your organization to look under the hood? I got this. It's a great way to get an overall, fairly quick assessment of exactly what needs improvement - prioritized by risk.
M&A Due Diligence
Who likes to waste money? I'm with you. Don't pay for a Ferrari when you're receiving...anything other than a Ferrari. And it doesn't stop there; also avaialbe to ensure everything is remediated prior to the final sale.
Productivity Improvement
I'm not sure there are many people, particularly in this area, that like to waste time for no reason. But, no one knows everything and no man is an island. It's for that reason, sometimes it's a good idea to have someone help you get from where you are to where you need to be.
On-site Consulting
I'll find everything - before (or after) anyone with regulatory authority does. But that's a good thing. No one's perfect, but what we should be striving for when lives are on the line. Better I find it than anyone else - in a relaxed, friendly manner and without consequence.
Personnel Training/DP
While this isn't anything new, the demand has increased. Someone to literally be the trainer, train the trainer or actual designated person to oversee your entire Quality program.
