Where to get meddev FSCA (Field Safety Corrective Actions) trainings

J

Josh84

I have been trying to find training for meddev Field Safety Corrective Actions but have not found much luck. Most of what I have found deals with vigilance and monitoring. I have looked at sights such as ASQ but have not had success. Does anyone have suggestions as to where to look for such trainings?
 
Ronen E

Ronen E

Problem Solver
Moderator
Hello Josh and welcome to the Cove :bigwave:

Have you combed the FDA website? They have various training materials.

Cheers,
Ronen.
 
J

Josh84

Thanks Ronen, I have checked the FDA website but we are searching for EU specific training for FSCAs as it seems that they are handled a bit different from how the FDA handles recalls.
 
T

Tara.

Hello Josh84,

The only training that I have been able to obtain is through External Audits with my NB. I don't know of any formal trainings, although complex MEDDEV 2.12 does seem to lay it out pretty clearly. I had to read it several (10+) times in order to get the picture though!! Have you also read GFTH/SG2/N36? This is a guidance on Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices. P.S. if you find any training, please forward onto me if you don't mind!
Regards,
Tara.
 
J

Josh84

Tara,

I have actually had some luck with QARAD over in Europe being willing to conduct a FSCA training. Unfortunately we are awaiting upper management sign-off so it has not yet happened. I was working with Maurizio Suppo, he was willing to conduct a Webinar or in-person training, he was really easy to deal with and I was looking forward to working with him prior to the roadblock on my end. Let me know if you would like his contact info. Hopefully this will help...
 
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