Regulatory Open Forum

Hello everyone,

Is anyone currently doing the RAC course for Medical Devices?

If yes, I would like to connect with you to discuss, ask questions etc.

Please contact me @ v_saritha@yahoo.com or reply to this mesg.

thank you,

Saritha

Hello everyone,

Is anyone currently doing the RAC course for Medical Devices?

If yes, I would like to connect with you to discuss, ask questions etc.

Please contact me @ v_saritha@yahoo.com or reply to this mesg.

thank you,

Saritha

Hi Saritha,

I think you may be confusing two differed RAPS learning opportunities.  It took me a while to sort them out as well.  I am currently RAC-US and seeking a Certificate in Medical Devices. 

The RAC (Regulatory Affairs Certification) is obtained by studying the regulatory requirements of a region of the world and sitting for a 4 hour exam on a specified day.  There are 4 RAC options, US, EU, CAN, and Global.  This is an intense exam that requires months of preparation and it is helpful to have a study group. 

The Regulatory Affairs Certificate Program is a series of on-line courses that allow you to specialize in learning the regulations regarding product types.  The three types of Certificates are Medical Devices, Pharmaceuticals, and Dual Track for Medical Devices and Pharmaceutical.  The certificate program allows you to take on-line courses on nine topics (you get to select some topics, others are required) related to the product type you are studying.   Each course can take from 2-12 hours to complete and you must complete all nine courses in a 6-month period to obtain the Certificate.  These courses have an exam at the end of each one, but if you fail you are allowed to review the areas where you struggled and then retake the exam.  

For someone relatively new to Regulatory Affairs, I would recommend considering obtain one or more Certificates first and then working towards getting RAC.  These on-line classes are a great source of study material that is required knowledge for the RAC.   The Certificate Program was not available when I obtained my RAC.   

Saritha, I hope this has been helpful, and Good luck!

Sara

Hello everyone,

Is anyone currently doing the RAC course for Medical Devices?

If yes, I would like to connect with you to discuss, ask questions etc.

Please contact me @ v_saritha@yahoo.com or reply to this mesg.

thank you,

Saritha