Dear Colleagues, I am seeking confirmation on the following queries regarding the forthcoming Windsor Framework regulation: Will the regulation require changing the testing and batch release activities read more
They are referring to this document FAQ 2.1 and 2.2 2017_11_CTFG_Question_and_Answer_on_Reference_Safety_Information_2017.pdf (hma.eu) However, it clearly says that using the SmPC is acceptable if used read more
The technical documentation structure for nonmedical devices can be found in the EMC directive in Annex II (2014/30/EU) ------------------------------ Jacqueline Jean-Baptiste Director, RA/QA ----- read more
The structure of your technical documentation for nonmedical electric instructions is in the Annex II of the EMC directive (DIRECTIVE 2014/30/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 26 February read more
This is a great opportunity for those looking for positions within FDA and even those just wanting to spruce up their resume! DC/Baltimore Area Chapter Virtual Event: Tools and Tips To Enhance Your FDA read more
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Dear Colleagues, I am seeking confirmation on the following queries regarding the forthcoming Windsor Framework regulation: Will the regulation require changing the testing and batch release activities currently performed in Ireland to Northern ...
This is a great opportunity for those looking for positions within FDA and even those just wanting to spruce up their resume! DC/Baltimore Area Chapter Virtual Event: Tools and Tips To Enhance Your FDA Career Application| RAPS ------------------------------ ...
Hi everybody, I would like to know if there is any in person training to be a Quality (such as ISO) or Regulatory inspector for drug making companies and you are called to various companies for inspections. Winston Costa Pereira Sent from my iPhone
This message was posted by a user wishing to remain anonymous Requesting kind advice : A fictional pilot scale interventional study with health supplements. Is it mandated that the name of the investigational product that appear in product description ...
Dear All, We are developing parenteral solution for injection with generic buffer, and require information about the requirement of the ranging (excipients ranging study) for the parenteral ANDA. Could you please help us with this? Thanks ...
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