RAPS RAC - Regulatory Affairs Certification Tips

V

virpatel

I am preparing for RAC US exam. I started reading 21 CFR 210, 211,312,314, 600 and 610. For medical device i am going to read 810 and 820.
any usefull online regulation for risk assesment?
Any other special part of 21 CFR that i should read? your suggestion are most wel come.

Thanks
 
S

Seattlehiker

Hey all,

I am new to the forum. I am interested in forming a study group for RAC General scope. If anyone interested in discussing and making a study plan please leave your emails.
 
B

Bee808

I am located in Los Angeles and am looking to see about study groups in this area. Please contact me if you are in the area and would like to form a study group for the RA certification exam spring 2013
 
B

Bee808

A while back I contacted the SF chapter and they did not have anything at the time. I am at a loss right now. Would you have any other suggestions?
 
D

Deb simpson

Hi I am new here and preparing to take the RAC---is this an open book exam like ASQ exams? please advise ---thank you :rolleyes:
 
A

arbela

Having recently passed the exam for the RAPS RAC certification - GS - Global Scope, i felt it could be great to point out some tips for those who wish to be certified.

First i would advise on buying the RAC exam preparation book available in the RAPS bookstore...although expensive, they are really, realluy worth it. It?s interesting to note that, generally, the contents of the exams are free regulations, so why spend a lot of money on a book when you could read the regulation for free?

Well, try to read them all (which includes medical devices, pharma, cosmetics and other healthcare products) and try to make sense of the systems for youorself and you will understand what i mean. One of the problems of the regulations is the difficulty to understand several documents written by different people on different timeframes. What the RAPS books do is condense all this info in a practical and easy to understand way.

Second, i cannot stress enough the need to fully understand two concepts: device lifecycle and risk management. I was happilly surprised to see that, of the exam questions that i took, more than a half was somehow related to risk management, if not directly citing the process. It?s great to know that this basic principle of healthcare regulations has a great treatment on the exame and on certified professionals.

That?s the two main tips i remember at the moment, if i remember anything else i will reply to this thread.
hi marcelo.
i'm sort of new to the cove, so i'm not sure my question is appropriate. it concerns the raps exam preparation book. as you noted, it is indeed rather expensive, so i was wondering if it is ok to ask if people who already passed the exam and have no more use for it would be interested in selling it as a second hand book.
arbela
 

Marcelo

Inactive Registered Visitor
Hello Arbela, and welcome to the Cove!

i'm sort of new to the cove, so i'm not sure my question is appropriate. it concerns the raps exam preparation book. as you noted, it is indeed rather expensive, so i was wondering if it is ok to ask if people who already passed the exam and have no more use for it would be interested in selling it as a second hand book.

I don't think it's a problem, but I?m going to ask the other moderators.
 
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