Onsite Audit (Shenzen, China) - Anyone have any experience with a consultant?

L

labjunkie

#1
Hello everyone!

First time I've browsed through this website and it's been an amazing source of information so far.

I was hoping that someone here can offer some direction. I work with a medical device manufacturer and we seek help regarding preparation for the 21 CFR 820.

Anyone have any experience with a consultant? We're looking for someone with experience to help guide us through the process, and be present for any potential audit/inspection from the FDA.

Thanks in advance!

Josh Novak
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: Consultant for Onsite Audit - Anyone have any experience with a consultant?

It's a big world out there. Since you didn't put information about where you live in your profile, you might want to state where you are looking for a consultant. Japan? Kentucky in the US? India? China? The more information someone puts in their profile, the easier it is for folks to help.
 
L

labjunkie

#3
Re: Consultant for Onsite Audit - Anyone have any experience with a consultant?

Hi Marc,

Thank you for reminding me! Our facility is in Shenzen, China.

Any help would be appreciated :)
 
M

maxenix

#4
Re: Consultant for Onsite Audit - Anyone have any experience with a consultant?

You can contact with SDATC (Training certer of State food&drug administration, belongs to SFDA), they often cooperate with FDA and have some good consultants.
 
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