General

Hi Sarah

I'm pinning this to the top so it stays at the top of the newsfeed. I also suggest that you post this on our ASQ ...

I answered the survey, but based on some of your survey questions and I am curious what directions your literature ...

Thanks Trish! I will post it today!

Thanks Jeremiah! There really isn't a lot of information from an academic side when it comes to GMP pharma / FDA ...

are you just looking for companies that have FDA related products?

Where I am, we have 4 levels: Manual, SOP, Work Instructions, Forms. As far as the Manual, we still utilize ours and ...

Sounds good. Thanks for taking the time to share Janine! Greatly appreciated!

I'm referring the hierarchy different from traditional way of policy,manual,procedures and records- this will ...

Hi Michelle,

Your list of documents is pretty much standard. Initially a lot of companies were Gung Ho about ...

Hi David ,

I agree with you ,initially many thought that they get rid of the quality manual with 2015 version of ISO ...

Probably not. I believe student membership is only for people who are currently enrolled as a student.

If the body of knowledge (BOK) for the CQA exam changes, which it did, then the Handbook is updated to keep it aligned ...

MediaLab has several modules including Doc Control, CE, and event management, which is called IQE (I think). You ...

We utilize the QMS product from EtQ. They have improved it over the 13 years and have great options plus ...

Trackwise was one I used to run in a lot, especially in FDA regulated industries.

Hi Ramil

I also was looking for something to manage the CAR more effectively. Later we ended up using a sharepoint ...

SmartSolve is a good system for CAPAs and NCs. I think that it is more user friendly than Trackwise.

Like everything, this is an “it depends.” Temporary personnel need to be trained on the aspect of the job they will ...

As Jeremiah Genesh said, “ it depends” . If due to special circumstances you need temp employees and do not have the ...

Hi Mark,

As I'm sure you are aware, equipment validation is a critical component of manufacturing; even slight ...

Hello Mark,

Lisa brought up some good points about equipment used to manufacturer medical devices. If you have not ...

Thank you Lisa. Very helpful.