RAPS RAC - Regulatory Affairs Certification Tips

arbela said:

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

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arbela said:

<snip> 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. <snip>

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Marcelo Antunes said:

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.

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