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Sarah Christie
Please allow me a moment of your time. My name is Sarah Christie and I am a Doctoral Candidate at Florida Tech that is ...

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?

Mark Frey
Hello Everyone, I have a process for qualifying raw materials prior to manufacturing of a product using those raw ...
Michelle Hartman
I'm curious about the number of document hierarchy levels used in new or most Quality Management Systems today. ...

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 ...

Paulo Marcos Amorim Dos Santos
I was graduated in a two years college in Ontario in December 2020. Am I eligible to apply for Student Membership?

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

Shamantha Gunawardena
Just wondering what was the motivation for the 5th edition over the 4th? Has the auditing methods and practice ...

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

Michael Matuszewski
I am curious if there are some members that is familiar with developing sampling plans during process ...
Ramil Honrada
Hello Everyone, I am not sure if this is the right forum for my question, but I am looking for recommendations on good ...
Ramil Honrada Jun '21

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 ...

Duke Okes Duke Okes Jun '21

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.

Janine Clarkson
Hello everyone, I am just wondering how companies that use temporary employees handle training for them. We've ...

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 ...

Mark Frey
Hi Everyone, I'm developing a manufacturing platform from R&D for a medical device. Would I need to do ...
Mark Frey Jun '21
Hi Mark Frey ‍ - I'm just tagging a couple of members who might be able to help

Cinta Burgos ‍ , George Marcel ‍ , James ...
Mark Frey Mark Frey Jun '21
Thank you Trish.

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 ...

Mark Frey Mark Frey Jun '21

Thank you Lisa. Very helpful.

Michael Mladjenovic
What is in your opinion the best way for quality professionala to make transition to Quality 4.0? Join the ...