G M Butcher
Total Contributions 31
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Nov 7, 2017Yes the approach is the same, only the considered parameters/factors/attributes....
Nov 7, 2017. . . are different....
Nov 3, 2017Does the organization have an SOP for risk management/RA?...
Nov 1, 2017Improper is a bit vague. Is there an established protocol (SOP, etc.) that calls for...
Oct 9, 2017Expand the risk assessment from intended use to actually identify the GxP feature/process/data affected for...
Oct 9, 2017Probably not, not enough info given to give a good answer.More important is the reliability...
Oct 9, 2017The question also indicates that it may not be best to begin ones consulting career...
Oct 5, 2017There is no validation/use-at-will. The finance dept. is subject to the continuing requirements after completed...
Oct 4, 2017It is not a question of validate or not validate. The question is do we...
Sep 21, 2017Not that I am aware. Sometimes copies find their way to the internet, so you...
Sep 19, 2017continuation . . . Perhaps consulting effectiveness is an unrecognized concern? Have you considered, for...
Sep 19, 2017You may be asking about two topics, economics and ethics. In the ethics arena, do...
Sep 19, 2017ISO catalogue indexed by field of interest https://www.iso.org/standards-catalogue/browse-by-ics.html ...
Sep 16, 2017The old/continuing confusion between certification/registration and accreditation has risen again in one above answer. The...
Sep 12, 2017Cannot speak for others but this question goes beyond the knowledge for which I can...
Sep 5, 2017Yes of course, but the point is to get you to properly use the DS,...
Sep 4, 2017Here we go again. Back in sixth grade Mrs. Perkins taught me to read a...
Sep 4, 2017Karen Boyd - the usage for 'or' can be either inclusive or exclusive, but I...
Sep 4, 2017In as much as this is an english language forum, perhaps a version in that...
Sep 4, 2017what does the validation plan call for? was SMBS considered during IQ? ...
Sep 4, 2017This and the other question really belong in another forum. how closely does the vendor...
Aug 31, 2017When entering the medical device marketplace the foresight of including a cost for regulatory conformance,...
Aug 31, 2017Try searching on the phrase 'manufacturing representatives in medical devices'....
Aug 29, 2017Before applying your own detailed knowledge of what constitutes 'validation' to a suppliers use of...
Aug 23, 2017My reply just above suggests that you refer to the regulatory authority of concern. That...
Aug 21, 2017The regulatory authority itself establishes both requirements and provides for what to do when deciding...
Jul 31, 2017Perhaps it would be wise to read (or re-read) the posted letter, as it states...
Jul 27, 2017Agree with Julie O. because -The meaning is straightforward, including definitions of to whom the...
Jul 25, 2017The Dietary Supplement Health and Education Act of 1994 is a predicate rule so 21CFR...
Jul 9, 2017As the diameter of the small intestine, presumably the target organ, is about one inch...
Jul 6, 2017ISO - if it is not part of the anticipated scope of registration it is...
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