3 replies to this topic

[blopezh]

We promoted a QC lab tech to a regulatory tech. Can anyone advice where can I find certification for the regulatory tech. 

[Brothbro]

When you say regulatory, I assume you mean FDA regulations? To my knowledge there isn't certification program for knowledge of FDA code. Instead you may look for training programs to get their knowledge up to speed. If you hold any additional certifications (SQF, Organic, etc.) you may want to start by looking for training resources on the websites for these organizations. For FDA regulations, honestly I recommend reading the law itself. It's tedious but it's really the best place to learn exactly what the rules are. At the very least the GMP sections of the FDA code are a great read for someone looking to understand compliance.

 

Below is the FDA code, only certain parts will pertain to your operation. Typically, reading Part 110 is a great start.

https://www.ecfr.gov...-I/subchapter-B

[jfrey123]

I too cannot think of any certified type course one could take when handling the role of a regulatory tech.  It's often listed in the job descriptions for QA Managers and Supervisors, and the way I've handled it is to list out an expectation in the job description that the person performing the duties keep apprised of regulatory changes and be generally knowledgeable of the CFR's affecting your business.  We include things like adding the CORE outbreak table and a list of current recalls to our monthly meeting reports, we cite relevant CFR's in our SOP's.  To make it a trackable metric of their job, you could ask them once a month to email a memo showing something they've discovered from the press releases your relevant regulatory body publishes (FDA/USDA/what have you).  This person can sign up for email alerts or RSS feeds from their websites to have updates and important information delivered directly to their inbox for dissemination as needed.

[blopezh]

thank you so much for your answers they were very helpful.