Anonymous: The many hats we sometimes wear often don't fit as well as others, do they?
I would familiarize myself with the FDA
Quality Systems Inspection Guide, and
QSIT Technique Manual. I see those are not specific to Inventory Control but the principles are very relevant to the design of the Inventory System.
Take a look at some FDA WLs on Inventory Control to see what NOT to do, and what FDA looks for. Under the horrendous new FDA web reorganization, you can no longer sort these letters by particular QMP/QSR (or even find the older letters at all). But you can Google them by
"inventory control" "warning letters" and site:fda.gov, e.g.:
Cache commodities of 2018 and
Syfrett Feed of 2014.
The letters are also for sale in private industry. Here is one that put some letters on its blog:
FDA Sent These 9 Warning Letters for Food Companies | October 2018 - Govzilla
Good luck!
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Andrea Chamblee Esq., RAC, FRAPS
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.
Silver Spring MD
United States
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Original Message:
Sent: 09-Apr-2020 10:39
From: Anonymous Member
Subject: Ask Me Anything Session: The Strategic Role of the Regulatory Professional
This message was posted by a user wishing to remain anonymous
As a regulatory professional working in a device startup that is still in early product development, 90% of my time is dealing with quality questions and manufacturing operation questions like inventory control. We don't have a dedicated manufacturing department. So by default, I am the go-to person for anything that is not engineering or business in the company. Engineering is handled by the engineers, and business is handled by the CEO and an assistant. I have no experience in manufacturing. I always have trouble answering questions on manufacturing. In the past companies, this was handled by a production manager or a process engineer. I know the general outline of manufacturing (e.g. from receiving to shipping). I would think my role would be more regulatory focused and more strategic rather than focusing on QA 90% of my time, but given what I've been doing, I am not sure what regulatory means. Does anyone have suggestions on what I can do? Anyone have a better definition of a regulatory professional?
Original Message:
Sent: 08-Apr-2020 14:30
From: Annie O'Brien
Subject: Ask Me Anything Session: The Strategic Role of the Regulatory Professional
Thanks for joining us for this wonderful session, and a big thank you to our experts @Amaris Ajamil and @Adriana Gavrilciuc.
As a reminder, you can find the Regulatory Focus Article Series, The Strategic Role of the Regulatory Professional HERE.
Feel free to keep the conversation going by adding your question to this thread.
Thanks again!
Annie
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Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
Original Message:
Sent: 08-Apr-2020 13:27
From: Annie O'Brien
Subject: Ask Me Anything Session: The Strategic Role of the Regulatory Professional
Hi Members,
Recently, RAPS released it's quarterly article series focusing on the strategic role of the regulatory profession. Today, we have two experts, Amaris Ajamil and Adriana Becker, who will be discussing the article series and available to answer your questions in real time.
Please use this thread to ask the experts your questions.
Can't wait to read the discussions!
Best,
Annie
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Annie O'Brien
Community Manager
Regulatory Affairs Professional Society
regex@raps.org
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