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Timothy Parrent
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
Hello team!

Who am I?
  Tatiana Miranda, Leader, CoE Foods and CHA/CFSQA
What do I do?   I am a Principal Quality ...
Who am I? Paul Mignon, currently Secretary of Division
What do I do? I am a Supplier and Internal Auditor at Central ...
Who am I?   Stephanie Gaulding, CQA and CPGP
What do I do?    I work for a consultancy, Pharmatech Associates, Inc., ...
Who am I? Jose Luis Ruiz G. LSSBB.

What do I do? I work for a LINCRECE consultancy, to Pharmaceutical sector, Food and ...
Who am I?   Janeen Skutnik-Wilkinson
What do I do?   Head of Quality Intelligence @ Biogen, Chair of IPEC Americas, ...
Who am I?   Harika Kotu, CSSGB
What do I do?   Manager, Technology Transfer at Matrivax Corporation with a focus on ...
Who am I?   Jeremiah Genest, CPGP, CMQ/OE
What do I do?   Head of Digital Quality at Thermo Fisher Scientific, ...
Adam Brock Adam Brock Dec '19
Who am I? Adam Brock, CQPA-CQA-CSSGB

What do I do? I am the Director of Food Safety, Quality & Regulatory Compliance ...
Who am I?  Linda Marcoot, Registered Dietitian, Masters in Business Administration, ASQCHA, FSPCA Lead ...
Who am I? Tracy Nwonyimi, BSc Biochemistry, MSc Quality Assurance, HACCP certification. 
What do I do?    Still ...
Luz Tatiana Miranda
AUDITING IN THE DIGITAL AGE Thursday, October 6 and Friday, October 7, 2022 CALL FOR SPEAKERS: For the 2022 ...
Harischandran S
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
I suggest you start with the ASQ Pharmaceutical GMP Professional Handbook, H1386, or the current second edition ...
Hello,
I am also a member of SQA and actually will be attending a Quality College course on GMP Fundamentals next ...
I am currently in the process of studying for CPMP. In addition to buying ASQ book, I recommend purchasing the ...
Wonder if you've details of the
SQA Quality College course on GMP Fundamentals.

Thanks
I am leading a virtual workshop on excipient GMP auditing in 2 weeks. You can get details at ipec-americas.org
Harischandran - Thanks for asking the question. All of the replies are good. It is an open book test, so you will be ...
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 ...
Deal fellow members,

I am from Canada. Touching the same topic of studying for cGMP. Is there any initiative from ...
Please contact Toronto section for study group.

Chaitanya
Mark Green
Does anyone have any insight they could share concerning their experience with Enterprise Quality Management ...
Mark Green Feb '21
Norm Howe
NSF International is presenting a free webinar “Poka Yoke Awareness” on March 30, 9am EDT. How can you improve ...
Norm Howe Mar '22
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 Jan '21
Hi:

I focus on auditing and leave the FDA Compliance generating and establishing up to others who are more current ...
Norm Howe Norm Howe 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 ...
Welcome Norm!
Shamantha Gunawardena
Wondering about the process of getting supplier into the Approved Vendor Listing (AVL), and ensuring supplier ...
I would recommend you refer to the GHTF SG3/N17:2008 Supplier guidance. You can find this excellent document ...

Thanks, Edwin. That's a fabulous source for great information.

Hello Bill,
Thanks for the post. May I request posting on LinkedIn on the RISK Management. I think the members of the ...
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 ...
Lauren Stephenson
Hello FDC Division! I am currently working on the QMS for our small biotech company. I am looking to iron out our ...
Jason Zuch Jason Zuch Dec '21
Has your organization discussed the concept of "pre-defined" Incidents (less than Deviation investigations) ...

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

  1. Predefined events, ...

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

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 ...

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 ...

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 ...

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