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Regulatory Affairs Training in Food

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Posted 07 August 2018 - 02:03 PM

I am looking for the best opportunities to move my knowledge forward in order to be successful as a Regulatory Manager in a food/spice plant. Here is my quick back story. I have a BS in Cell Molecular Biology from Missouri State University, a MS in Biotechnology – Bioinformatics from University of Maryland, and about 10 years of experience in a food safety lab and  have recently moved to being the Regulatory Manager for a spice company in the midwest. After starting here I got my HACCP certification, and it sounds like I should be getting the training for SQF and Food Defense Coordinator within the next year.


If you were to advise someone in my position on training to obtain, what would you suggest? What do you perceive the benefits would be to add the certificate in Food Laws and Regulations to my repertoire?


All recommendations are appreciated.




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Posted 07 August 2018 - 05:17 PM

You need to be able to understand what they "law" is trying to actually say, and how it affects your process. You need a firm understanding on import/export regs for each country (if applicable)

IMHO you cannot learn that part in a class room.... it is something experience dealing with regulatory stakeholders (and maybe shareholders) will teach you overtime


For example, my CFIA inspector was here last week, she flat out said to me..."traditionally 165F for 15 minutes" now, there is no regulatory enforcement that comes from her statement, but she was trying desperately to enforce it. It will be your job to know all the regs better than the inspectors (state/feds/other countries) as well or better than they do


I would urge you to develop and photographic memory, and know whats worth fighting, and whats worth just saying "ok fine, we'll do it your way"


I wouldn't spend a cent of food law and regs training....regs are not final neither is the guidance so you'd be wasting your money

Please stop referring to me as Sir/sirs

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Posted 08 August 2018 - 11:43 AM

I'd echo Scampi's comments - I'm responsible for regulatory affairs and have virtually no formal training in it whatsoever (my undergrad/postgrad is in Physics...) barring a few 1-day courses for briefings on e.g. new labelling regs. Almost everything I know I've learnt on the job - started as an office admin to pay the bills, did a lot of reading, asked a lot of questions and got promoted three times in the first three years this way.


Read the relevant regs and guidance until you know all the important parts by memory, or at least know where to go in which reg to find the right answer. Use questions that come up at work as a way to "revise" by forming an opinion based on what you think you know, and then referring to the regs/guidance to check this - you should find that with some practice the two start becoming quite well aligned ;)
Form as strong a relationship as you can with your regulators - we've hosted training days for our local equivalent of the FDA, and regularly let them bring students around as part of their induction process as there aren't many other manufacturers in the area. In return we get genuinely collaborative visits for official inspections and plenty of open discussion about regulatory matters, as well as the opportunity to candidly talk through regulatory matters to better understand how they're actually being interpreted by the people enforcing them, rather than the best guess based on the somewhat arcane language in which such things always tend to be written.

As Scampi noted, you'll also get a feel for which bits they view as important and which are areas where there is room for genuine debate, as long as you can substantiate your position.

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