Recent Topics

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

What do I do? I am a Supplier and Internal Auditor at Central ...

What do I do? I work for a consultancy, Pharmatech Associates, Inc., ...

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


What do I do? Manager, Technology Transfer at Matrivax Corporation with a focus on ...


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


What do I do? Still ...


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


SQA Quality College course on GMP Fundamentals.
Thanks




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

Chaitanya

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




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

Thanks for the post. May I request posting on LinkedIn on the RISK Management. I think the members of the ...


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



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


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

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



Forum Topic List
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Do you have the 'right' skills needed during the Pandemic?
by Luz Tatiana Miranda - Mar 10, 2021 4:44 pm - 3
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Re: Do you have the 'right' skills needed during the Pand...
by Wanda Sturm
Apr 6, 2021 6:57 pm
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Do you have the 'right' skills needed during the Pandemic?
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FDC at the WCQI
by Luz Tatiana Miranda - May 26, 2022 4:41 pm - 0
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FDC at the WCQI
by Luz Tatiana Miranda
May 26, 2022 4:41 pm
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FDC at the WCQI
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ASQ Audit Division Conference Call for Speakers!!!
by Luz Tatiana Miranda - May 26, 2022 4:10 pm - 0
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ASQ Audit Division Conference Call for Speakers!!!
by Luz Tatiana Miranda
May 26, 2022 4:10 pm
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ASQ Audit Division Conference Call for Speakers!!!
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2022 WCQI - FDC Division Events?
by Diane Kulisek - May 10, 2022 4:14 pm - 0
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2022 WCQI - FDC Division Events?
by Diane Kulisek
May 10, 2022 4:14 pm
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2022 WCQI - FDC Division Events?
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Good Distribution Practices (GDP) in Pharmaceuticals
by Shamantha Gunawardena - Mar 24, 2022 10:22 pm - 2
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Re: Good Distribution Practices (GDP) in Pharmaceutic...
by Shamantha Gunawardena
Mar 28, 2022 3:13 pm
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Good Distribution Practices (GDP) in Pharmaceuticals
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Poka Yoke Awareness
by Norm Howe - Mar 24, 2022 10:06 am - 0
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Poka Yoke Awareness
by Norm Howe
Mar 24, 2022 10:06 am
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Poka Yoke Awareness
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FDA Latest Plan for Manufacturing
by Jeremiah Genest - Mar 9, 2022 3:50 pm - 2
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Re: FDA Latest Plan for Manufacturing
by Jeremiah Genest
Mar 10, 2022 3:41 pm
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FDA Latest Plan for Manufacturing
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Webinar Opportunity
by Daniel White - Mar 7, 2022 2:26 pm - 0
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Webinar Opportunity
by Daniel White
Mar 7, 2022 2:26 pm
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Webinar Opportunity
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Supplier Vetting and Approved Vendor Listing
by Shamantha Gunawardena - Feb 23, 2022 8:42 am - 3
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Re: Supplier Vetting and Approved Vendor Listing
by Jack Dhuwalia
Feb 25, 2022 9:22 am
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Supplier Vetting and Approved Vendor Listing
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Looking for a CQIA in Tempe, AZ
by Luz Tatiana Miranda - Feb 2, 2022 4:50 pm - 2
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Re: Looking for a CQIA in Tempe, AZ
by Luz Tatiana Miranda
Feb 4, 2022 11:21 am
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Looking for a CQIA in Tempe, AZ
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Seeking Resources on Minor Quality Events/Deviations
by Lauren Stephenson - Dec 21, 2021 2:27 pm - 6
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Re: Seeking Resources on Minor Quality Events/Deviati...
by Jeremiah Genest
Jan 15, 2022 5:38 pm
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Seeking Resources on Minor Quality Events/Deviations