SBS - The best value in QMS software

RAPS RAC - Regulatory Affairs Certification Tips

Marcelo

Inactive Registered Visitor
#1
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.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
<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

#3
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
#4
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

#5
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

#6
Hey Marcelo.

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

Eve08

#8
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

#9
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

#10
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:
 
Thread starter Similar threads Forum Replies Date
G RAPS RAC - Regulatory Affairs Certification Help Professional Certifications and Degrees 3
S RAC (Regulatory Affairs Certification) from RAPS vs. a University Professional Certifications and Degrees 4
Z RAPS RAC without Regulatory Experience - Break into the regulatory affairs industry Professional Certifications and Degrees 2
K RAPS RAC - Resources to prep for the RAC exam that don't cost an arm and a leg Professional Certifications and Degrees 3
L RAPS RAC EU Certificate: is anyone going to put hands on? Professional Certifications and Degrees 4
F What is the duration of the RAPS RAC (EU) Exam? Professional Certifications and Degrees 11
cscalise RAPS/Med Dev EU MDR Guidebook - Reviews or Opinions? EU Medical Device Regulations 0
M Informational From RAPS – Danish Medicines Agency Ramps Up Capacity in Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – 27% Will be Compliant? Survey Highlights Lack of Readiness for EU MDR Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – Novartis Inhaler is First Device to be Certified Under MDR Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – Prep for Brexit: UK Seeks £25M Freight Service to Deliver Medicines, Devices Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay Medical Device and FDA Regulations and Standards News 3
M Informational From RAPS – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’ Medical Device and FDA Regulations and Standards News 2
M Informational From RAPS – UK NB Will Not Apply for EU MDR/IVDR Medical Device and FDA Regulations and Standards News 11
I Should I get IRCA ISO 13485 certification or RAPS certification? Career and Occupation Discussions 3
S RAPS Regulatory Affairs Certificate Program Training - Internal, External, Online and Distance Learning 1
S Mathematics for Regulatory Professionals - RAPS Focus Article Other Medical Device Regulations World-Wide 0
R RAPS Certification Exam Prep Study Group for Spring 2014 Professional Certifications and Degrees 2
S 1st AHWP-RAPS Joint Conference @ KL, Malaysia 2-3 Dec 2013 Other Medical Device Regulations World-Wide 2
S RAPS Article on STED (Summary Technical Documents) Other Medical Device Regulations World-Wide 1
Hershal Just for fun raps Coffee Break and Water Cooler Discussions 0
S FDA Enforcements for 2011 - RAPS article on FDA Inspections and Enforcements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L RAPS (Regulatory Affairs Professionals Society) books - Are they worth it? Professional Certifications and Degrees 8
R RAPS Certification Relevant to IT Business Analyst? Professional Certifications and Degrees 4
N RAPS Certification and RAPS Testing Professional Certifications and Degrees 1
F RAPS Annual Conference & Exhibition 2010 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
F RAPS Qualification - How Difficult to get are they? Professional Certifications and Degrees 4
M RAPS (Regulatory Affairs Professionals Society) Brazil LinkedIn Network Other Medical Device and Orthopedic Related Topics 0
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 1
K Regulatory Affairs Certification (RAC) Exam - November 2020 preparation Professional Certifications and Degrees 0
P RAC-US Spring 2020 Study group_Discussions Professional Certifications and Degrees 19
T RAC US certification - Study group Professional Certifications and Degrees 7
S Regulatory Certification Exam (RAC) - Global Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
E RAC EU preparation aids - Tips on how to prepare for RAC EU exam Professional Certifications and Degrees 2
W RAC EU/Global focus certification - Study Group for Spring 2015 Professional Certifications and Degrees 4
M RAC (US) Exam - Fall 2014 - Study Group? Professional Certifications and Degrees 4
C Suggestions for the RAC Regulatory Affairs Spring 2014 - US exam Professional Certifications and Degrees 1
D RAC Regulatory Affairs Spring 2014 EU or Global Exam Study Group Professional Certifications and Degrees 15
P RAC (Regulatory Affairs Certification) US Spring 2013 Preparation Study Group Professional Certifications and Degrees 3
G Preparing for RAC Exam - Need to take online-course at RASP? Professional Certifications and Degrees 2
AnaMariaVR2 Preparing for the RAC Examination -- Developing an RAC Study Plan Professional Certifications and Degrees 1
R Information on RAC US Test Preparation Material Training - Internal, External, Online and Distance Learning 1
F Regulatory Affairs Certification (RAC) April/May EU Exam - Anyone doing it? Professional Certifications and Degrees 10
P Regulatory Affairs Professionals Society RAC exams - Information Request Professional Certifications and Degrees 6
N Preparation time for the 'spring' RAC Exam - sufficient time? Professional Certifications and Degrees 1
C Regulatory Affairs Certification (RAC) Certification Professional Certifications and Degrees 83
M RAC Certification - R.A. Specialist in a Medical Device company Professional Certifications and Degrees 16
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5

Similar threads

Top Bottom