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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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ASQ FD&C Division Elected Officer Nominees For The 2022 Term

The ASQ Food, Drug, & Cosmetic (FD&C) Division nominating committee is pleased to announce the nomination of the following elected officers for the 2022 term: Paul Mignon – Chair Lance Harding – Chair-Elect Lisa El-Shall – Treasurer Shelly Coggins – Secretary Tim Parrent – Immediate Past Chair/Nominating Committee Chair Additional ... more

Posted by Amanda Gainey on Food, Drug, & Cosmetic Division Oct 11, 2021 2:45 PM CDT

Mentoring Program Update

The FD&C Division is partnering with the NextGen Mentoring Group to bring qualified mentors and interested mentees together. If you are interested in having a mentor or being a mentor to someone or would just like to learn more about the program, please contact Karina Rodriguez ( karina.c.rodriguez@gmail.com ). Applications for anyone ... more

Posted by Timothy Parrent on Food, Drug, & Cosmetic Division Sep 29, 2021 4:54 PM CDT

ASQ Certified Food Safety and Quality Auditor Handbook, Fourth ed.

We're happy to announce that The ASQ Certified Food Safety and Quality Auditor Handbook, Fourth Edition , is now available for order ahead of schedule! The new edition includes FSMA updates, preventive control principles and the importance of food system support programs such as product traceability and recall, facility design, and environmental ... more

Posted by Paul Mignon on Food, Drug, & Cosmetic Division May 7, 2021 10:14 AM CDT

Upcoming Events

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Recent Discussions

GMP Training Materials Required

9 62

Hi Everyone, I am new to this community. Am interested in GMP of pharmaceuticals. It will be helpful for me if ...

Harischandran S Apr '21

Apr '21

I suggest you start with the ASQ Pharmaceutical GMP Professional Handbook, H1386, or the current second edition ...

Apr '21

Hello,
I am also a member of SQA and actually will be attending a Quality College course on GMP Fundamentals next ...

Apr '21

I am currently in the process of studying for CPMP. In addition to buying ASQ book, I recommend purchasing the ...

Apr '21

Wonder if you've details of the
SQA Quality College course on GMP Fundamentals.

Thanks

Apr '21

I am leading a virtual workshop on excipient GMP auditing in 2 weeks. You can get details at ipec-americas.org

Apr '21

Harischandran - Thanks for asking the question. All of the replies are good. It is an open book test, so you will be ...

Apr '21

A lot depends on your goal for GMP materials. Is it to study for the CPGP exam or to learn basic GMPs. Either way just ...

May '21

Deal fellow members,

I am from Canada. Touching the same topic of studying for cGMP. Is there any initiative from ...

May '21

Please contact Toronto section for study group.

Chaitanya

Introducing Me...

10 104

Who am I? Tim Parrent, Senior Member and CQM/OE What do I do? I lead the Corporate Quality Team at Mary Kay ...

Timothy Parrent Jul '19

Jul '19

Hello team!

Who am I? Tatiana Miranda, Leader, CoE Foods and CHA/CFSQA
What do I do? I am a Principal Quality ...

Oct '19

Who am I? Paul Mignon, currently Secretary of Division
What do I do? I am a Supplier and Internal Auditor at Central ...

Dec '19

Who am I? Stephanie Gaulding, CQA and CPGP
What do I do? I work for a consultancy, Pharmatech Associates, Inc., ...

Dec '19

Who am I? Jose Luis Ruiz G. LSSBB.

What do I do? I work for a LINCRECE consultancy, to Pharmaceutical sector, Food and ...

Dec '19

Who am I? Janeen Skutnik-Wilkinson
What do I do? Head of Quality Intelligence @ Biogen, Chair of IPEC Americas, ...

Dec '19

Who am I? Harika Kotu, CSSGB
What do I do? Manager, Technology Transfer at Matrivax Corporation with a focus on ...

Dec '19

Who am I? Jeremiah Genest, CPGP, CMQ/OE
What do I do? Head of Digital Quality at Thermo Fisher Scientific, ...

Dec '19

Who am I? Adam Brock, CQPA-CQA-CSSGB

What do I do? I am the Director of Food Safety, Quality & Regulatory Compliance ...

Dec '19

Who am I? Linda Marcoot, Registered Dietitian, Masters in Business Administration, ASQCHA, FSPCA Lead ...

Jan '20

Who am I? Tracy Nwonyimi, BSc Biochemistry, MSc Quality Assurance, HACCP certification.
What do I do? Still ...

Insight Needed on a Particular Software - Enterprise ...

Does anyone have any insight they could share concerning their experience with Enterprise Quality Management ...

Mark Green Feb '21

New member

3 15

Excited to be a new member of ASQ and the FD&C Division. I've been in the quality and manufacturing business ...

Norm Howe Jan '21

Jan '21

Hi:

I focus on auditing and leave the FDA Compliance generating and establishing up to others who are more current ...

Jan '21

Nice to 'meet' you, Bob. Well, we all have our different roles and that's a good thing. One amazing thing that we ...

Feb '21

Welcome Norm!

2020 Year in Review - Thoughts & Thanks

3 20

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

Nov '20

Tim: So true! Giving thanks that both my personal and work families are safe and free from Covid, keeps the ...

Nov '20

Hello Timothy and Rosemarie,

2020 has been a paradigm shift in the way we conduct business due to Covid 19.
Internet ...

Dec '20

Thoughts : I didn't know that we could all be so productive working from home; technology has evolved so much to ...

Seeking Resources on Minor Quality ...

6 15

Hello FDC Division! I am currently working on the QMS for our small biotech company. I am looking to iron out our ...

Lauren Stephenson Dec '21

Dec '21

Has your organization discussed the concept of "pre-defined" Incidents (less than Deviation investigations) ...

Dec '21

Building on what Jason said there are really three buckets when you think of deviations

Predefined events, ...

Dec '21

No, we have not discussed this in particular, but have alluded to something similar during interdepartmental ...

Dec '21

This is exactly what I was looking for, and gives me a lot to think about! Do you have any further advice on how to start ...

30d

Lauren, I can't think of any specific articles, white papers that go deep on this. Its always a surface approach ...

I wrote more on my thoughts on my blog - Managing Events Systematically – Investigations of a Dog ...

Image/Video Policy (Benchmarking)

6 31

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

Mar '20

Here's some ASQ stuff that may be helpful.

Mar '20

Thanks David, I should have been clearer.

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

Mar '20

Hi Jeremiah,

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

...

Mar '20

Thank you. That aligns nicely with what I am used to in the past. A little surprised we didn't have that here, but ...

Mar '20

We do not have any details for video conferencing requirements at this point. Health Authorities can insist upon ...

May '20

Okay here is a verison that we approved. Thanks to everyone who provided wording I appropriated. Any typos ...

Help a Doctoral Candidate out!

1 9

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

Sarah Christie Jul '21

Jul '21

I'd be interested in participating and seeing what correlations you draw.
Rob

Quality Applicants/Candidates - Where do you post and ...

4 19

Is anyone having trouble getting quality applicants or over qualified, for an entry level ($40k-$55k doe) FSQA ...

Valerie Strong Apr '21

Apr '21

Valerie,

By definition, entry-level means no experience. Perhaps you mean relevant food experience but no QA ...

May '21

Suggestion for posting:
https://careers.asq.org/jobs

May '21

Yes, we are having similar challenges with FSQA and SQF Practitioner role that we are currently trying to fill. We ...

May '21

Can you elaborate a little on the basic quals you're looking for? For example, are you seeking someone with a 2-year ...

PIC/S Draft Guidance on Change Management

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/

Paul Mignon
Division Chair

Lance Harding
Chair-Elect

Tim Parrent
Immediate Past Chair & Nominating Chair

Lisa El-Shall
Treasurer & Voice of the Customer Chair

Shelly Hanson
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

OPEN
Social Media/Internet Liaison Chair

Certification Chairs
CFSQA: Kyle Tatum/Todd Jacobs
CPGP: Mark Durivage

Access:

Public

Members:

2495

Community Admins