Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)

see that corrective action taken to correct existing product nonconformity or quality problems and Prevent recurrence of the problem The corrective action should Include explanations for how the firm will meet the requirements for all elements of the CAPA subsystem Gain working knowledge of the firm’s CAPA procedure before beginning evaluation of this subsystem Have Read more about Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)[…]

FTC Online Ad Guidance – what will FDA do ?

Yesterday FTC has come up with a set of guidelines for online advertising aiming in particular,  to address the myriad questions surrounding the use of such tools as Twitter and Facebook to promote products and disseminate messages.The key question is , FDA going to follow it, copy it if yes to what extent. The various Read more about FTC Online Ad Guidance – what will FDA do ?[…]