RAPS RAC - Regulatory Affairs Certification Tips

Marcelo

Inactive Registered Visitor
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.
 

Marc

Fully vaccinated are you?
Leader
<snip> 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? <snip>
Excellent point for many standards and regulations. Where people lose it is in the aspect of interpretations, which is why Elsmar is here - To ask others for help in interpreting standards, specifications and regulations for free.

Thanks for the post!
 
A

Auriel619

Hi Mmantunes,

Thanks for the tips regarding the General Scope exam. When you mention the Exam Prep books sold at the RACs store as a good resource, did you mean "Fundamentals of International Regulatory Affairs"?



I'm concerned that the textbook is only a reference book and not a test prep book. The website says "Please consider these materials to be simply a reference guide and not your sole preparation for the exam."

So if the book above isn't the book you used to prep for the exam, can you point me in the right direction or specify which book you thought was helpful in preparing you?

Thanks!


 

Marcelo

Inactive Registered Visitor
Hello Auriel, and welcome to the Cove.

Yes, I meant "Fundamentals of International Regulatory Affairs".

You are correct, it´s a textbook explaning the regulations and other documents for the test, and it´s not really a test prep book. Anyway, I would still recommend it for the reasons I cited on the original post.

There´s a 2010 RAC (General Scope) Practice Exam available from the RAPS website, but i did not use it, so I can´t recommend it.
 
C

cocowu1175

Hi: I would like to know is that sufficient that I just read the book"fundamentals of international regulatory affairs"only? Thank you very much.
 
A

abhaykumar

Hey Marcelo.

Can you please suggest any online site where I can get materials related to RAC.
 
E

Eve08

Hello all,

I am new here and plan to take a RAC (US) exam this fall.

I am looking for a study buddy and/or a study guidance and experience from those who have already passed this exam.

I went through the RAP webpage, found that 3-4+ books (?) are recommended to read/study for this exam - are they all really necessary? Does anybody have any experience with online courses?

Thanks.
 
B

Bee808

I am also taking the oct/nov 2012 exam. I feel that the online exam is a good way to see how the exam is structured. However what I have issues with is getting to really understand and talk through the different processes. That is why I am looking for a study partner. Though I have completed reading the fundamental book and take online exam once a week, I feel I could really use a study partner to bounce ideas and questions off of. Can someone recommend a study group.
I contacted the regulatory affairs for professionals via email and they recommended the San Francisco chapter. I have yet to see any groups that will be held by the sf chapter.
I am actively looking for a study partner or group and am taking recommendations. Thank you:bigwave:
 
A

Ajayreddy

Hai Bee,

I am also looking for study partner. I am plaing to take RAC (GS) in coming months. Do you have any materials or modal questions? Lets plan...

Thanks,
Ajay:agree1::agree1:
 
Top Bottom