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Getting into biotech QA from aerospace - Is it practical?

Mike S.

An Early 'Cover'
Trusted
#1
I have roughly 30 years of broad experience in QC/QA in electronic components and aerospace manufacturing environments (ISO9001/AS9100). Many of those jobs in my area are going away, but the biotech/pharmaceutical industry is growing nicely, and looks like it will for some time to come.

I see a lot of employment ads for people with experience with standards and regulations such as FDA, GMP, GxP, cGMP, CBER, CDER, CDRH, etc. I admit I don’t know anything about those regulations, and I am wondering how hard it would be to adjust to biotech. I am sure some of my experience is transferable, but not sure how much.

Has anyone else here made this type of a switch, or been in both fields, or otherwise have knowledge about whether this kind of field-switch is practical? I would appreciate any advice, experiences, thoughts, etc. that anyone has to offer on this subject.
 

yodon

Staff member
Super Moderator
#2
Basic electronic QA/QC skills are absolutely transferable. ISO 9001 parallels, in many ways, the ISO equivalent for medical devices, ISO 13485 but there are definitely some key and critical differences. Same goes for AS9100. Your familiarity with these standards will certainly help.

On the other hand, FDA doesn't YET recognize 13485 (they just announced their intention to do so but didn't give any dates). The Quality System Regulation (QSR) which, effectively, defines cGMP (the 'c' is for 'current' and you'll see cGMP and GMP often used interchangeably). That's free to review (eCFR — Code of Federal Regulations). If you read through that, you'll recognize the similarities to 9001 (requirement for a QMS, doc/record control, etc.).

(Note: CBER, CDER, and CDRH are just divisions in the FDA and they have their own guidance documents and such.)

I don't know how easy it will be to break into the space, though. Definitely being able to talk the language will be helpful.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
Having floated in and out of various industries with different regs it seems the "easiest" transfer to make from aerospace and electronics would be to medical device - or a company that makes components for medical devices.
There is a lot in common and ISO13485 and MDD are not that hard to pick up if you are used to other regulated industries.

I've had the most trouble working with pharma customers with a device background... Pharma folks (in the US) only care about FDA 21 CFR 210 and 211. (314, 600 if you're in drug development).

But I easily worked with aerospace and automotive folks. And semiconductors.

Get hold of a copy of ISO13485 and see what's similar to what you've done. I guarantee you're most of the way there. And check out 21 CFR Part 820 for the Medical Device Quality System Regulations. CFR - Code of Federal Regulations Title 21
 
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