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  • Hi Everyone, One of the IDE application requirements relates to manufacturing (21 812.20): "(3) A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and, where appropriate, installation of ...

  • We're proud to announce the names of the 38 professionals who passed the second-ever Regulatory Compliance Certification (RCC) exams , which took place in spring 2024. Each professional listed at this link has earned ...

  • Today, RAPS released the names of the 108 professionals who passed their RAC exams in spring 2024! Congrat u l a t i o n s t o t h e s e professionals, who join the growing list of 4,500 global professionals who hold ...

  • Hello, Recently we have been advised that our Titanium Dioxide vendor can no longer supply their USP material. Would validation on sunscreen formulas be required when a new supplier of USP grade TiO2 is found, provide all specifications are equivalent. ...

  • Speakers at #RAPSEuroConvergence tackled pressing regulatory topics like AI, MDR/IVDR, and the EU pharma legislation, but they also tackled more esoteric subjects. For example: is regulatory affairs more art, or science? @Ferdous ...

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