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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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1
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
1
7
Pharmaceutical Compliance Partners, LLC (PCP) is a boutique management consultancy focused on delivering ...
Michelle McGuinness
Dec '20

Hi:
I am only interested in GMPs for medical device manufacturers domestically. Thanks,,,Bob
I am only interested in GMPs for medical device manufacturers domestically. Thanks,,,Bob
5
I'd appreciate hearing of your best practices for maintenance and archiving of org charts.
Jeremiah Genest
Dec '20
3
17
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 ...
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 ...
2
10
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 ...
Thanks for replying.
I am looking for the rules of building a good GxP job description to include in a writing ...
6
40
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
Iam familiar with what you have discussed there also COTS which essential for the food safety ...
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 ...
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 ...
I am in the clinical world but also use expiration and retest dates for small molecules based from the ...
6
26
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 ...
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:
...
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 ...

6
54
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


Jeremiah -
This is fabulous and is similar to what we're doing currently so that's reassuring. Thanks so much. ...
This is fabulous and is similar to what we're doing currently so that's reassuring. Thanks so much. ...


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


The Cosmelab Warning Letter is a great example of why this is so important.
A recent, last half of 2019, 483 that ...
A recent, last half of 2019, 483 that ...
11
I would appreciate getting folks thoughts on the below table. Trying to ensure alignment ...
Jeremiah Genest
Jan '20
29
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.
Follow us on LinkedIn https://www.linkedin.com/in/asq-fdc-division-039b9619b/
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
Follow us on LinkedIn https://www.linkedin.com/in/asq-fdc-division-039b9619b/
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
Access:
Public
Members:
1587
Community Admins