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  • I agree with the prior comments with one caveat. I think the organization will be better off if you have your own staff immerse themselves in the 2016 standard, compare it side-by-side with the 2003 standard, and write your own prescription (Gap Analysis and Quality Plan) for your Quality Manual and procedure renovations. This is the responsibility ...

  • Hi Raja: On ISO 14971 the European Commission DG SANCO found conflict between the standard and Medical Device Directive some years ago. While this was based on a "letter" rather then "spirit of the law" interpretation there are philosophical pros and cons on many of the issues raised, for example:  - whether negligible risks should be eliminated ...

  • Dear colleagues, FDA does not have a list of claims it deems to be acceptable or not and as such, I struggle with weather our cosmetics, though intended to improve appearance and beautify, could make the claims of "anti-aging" and "rejuvenation". I understand that these are just words, but are these terms to FDA more of a claim that is intended ...

Rainer Voelksen, FRAPS, Talks Volunteering and European Advisory Committee

"Regulatory professionals need to hear the voices of those working in other countries. Just helping others to get used to hearing other languages is important, and you can be a cultural representative at the table in any stage of your career. The regulatory industry is increasingly global, but all regulators work differently. We must all work harder to become comfortable sharing information in an international space so that the industry can successfully continue to develop."

Rainer Voelksen, FRAPS


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