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Membership in the Food, Drug, and Cosmetic Division helps you enhance your professional knowledge and gives you access to people and tools that can help you continually improve your effectiveness on the job.

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ASQE Certification is in the process of becoming ISO certified to ANSI/IE 17024 Accreditation - Personnel Certification Body. more
Posted by Paul Mignon on Food, Drug, & Cosmetic Division Dec 3, 2020 12:03 PM CST

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Norm Howe
Excited to be a new member of ASQ and the FD&C Division.  I've been in the quality and manufacturing business ...
Norm Howe 10h
Michelle McGuinness
Pharmaceutical Compliance Partners, LLC (PCP) is a boutique management consultancy focused on delivering ...
Hi:

I am only interested in GMPs for medical device manufacturers domestically. Thanks,,,Bob
Jeremiah Genest
I'd appreciate hearing of your best practices for maintenance and archiving of org charts.
Jeremiah Genest Dec '20
Timothy Parrent
We all agree 2020 has been a unique year.  I thought it would be fun for people to share a few thoughts on something ...
Timothy Parrent Nov '20
Tim:  So true! Giving thanks that both my personal and work families are safe and free from Covid, keeps the ...
Hello Timothy and Rosemarie,

2020 has been a paradigm shift in the way we conduct business due to Covid 19.
Internet ...
Thoughts : I didn't know that we could all be so productive working from home; technology has evolved so much to ...
Jeremiah Genest
Anyone have some good guidelines for writing a good GxP job description they can share?
Jeremiah Genest Jul '20
HI Jeremiah - can you please be more specific at what you are looking at for a job description in terms of years of ...
Kim,

Thanks for replying.

I am looking for the rules of building a good GxP job description to include in a writing ...
Amanda Pape
Hi Everyone, I'm new to ASQ and the group! I thought I'd reach out to the group to see if anyone could recommend some ...
Amanda Pape Jun '20
IPEC-Americas has issued a guideline on stability testing of excipients. You can find the guideline on the ...
Hi Amanda,

WHO also has Annex 10, published in 2018:
...
Hi 
Amanda 
Iam familiar with what you have discussed there also COTS which essential for the food safety ...
Hi Amanda,

I am new to this community and the world of Quality- so this suggestion could be quite useless, and you may ...
HI Amanda,

I am in the clinical world but also use expiration and retest dates for small molecules based from the ...
Jeremiah Genest
I need to write a new image/video policy fairly quickly (just discovered my company doesn't have one and that I was ...
Jeremiah Genest Mar '20
Here's some ASQ stuff that may be helpful.
Thanks David, I should have been clearer.

I'm looking for policy statements from GxP facilities on the use of ...
Hi Jeremiah,

Below is verbiage I often use when creating 3rd party or regulatory inspection SOPs for my clients:

...
Thank you. That aligns nicely with what I am used to in the past. A little surprised we didn't have that here, but ...
We do not have any details for video conferencing requirements at this point. Health Authorities can insist upon ...
Okay here is a verison that we approved. Thanks to everyone who provided wording I appropriated. Any typos ...

Krista Anderson
All, This is my very first post so I apologize in advance if this is not the correct forum for this type of question.  ...
Krista Anderson Feb '20
Okay, I think it is important to have established  a rigorous supplier management program, here's a flowchart to ...
Jeremiah -

This is fabulous and is similar to what we're doing currently so that's reassuring.  Thanks so much.  ...
This is great. Reminded me of a table in a slide by Ferrante at ASQ in 2003.
dc832202fb1c9685c84ae811b9e38ea3-huge-fe
 

 Might I ask what was considered full vs reduced sampling?  And also whether there was any justification for using ...

This may or may not directly relate to the thread, but thought this would shed some valuable light on Incoming ...
The Cosmelab Warning Letter is a great example of why this is so important.

A recent, last half of 2019, 483 that ...
Jeremiah Genest
I would appreciate getting folks thoughts on the below table. Trying to ensure alignment ...
Jeremiah Genest Jan '20
Jeremiah Genest
In November, PIC/S published draft 1 of PI 054-1 “ Recommendation on How to Evaluate / Demonstrate the ...
Jeremiah Genest Dec '19

Community Information

Category:
Technical
Description:
The ASQ FD&C Division is the resource of choice for quality systems and leadership development in the Food, Drug, & Cosmetic industries. 
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Amanda Gainey
Division Chair

Tim Parrent
Chair-Elect

Lisa El-Shall
Immediate Past Chair & Voice of the Customer (VOC) Chair

Paul Mignon
Treasurer

Lance Harding
Secretary

Rosemarie Christopher
Scholarship and Membership Chair

June Morita
Audit Chair & Midwest Discussion Groups

Communities of Excellence (COE)
Food COE Leader: Tatiana Miranda
Drug COE Leader: Mark Durivage
Cosmetics COE Leader: Tim Parrent

Cathelene Compton 
Social Media/Internet Liaison Chair

Certification Chairs  
CFSQA: Kyle Tatum/Todd Jacobs
CPGP: Sandra Storli
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