By Anonymous on Tuesday, May 13, 2003 - 07:41 am:
2 short questions:
Anyone knows where in the CFR is the part that define the education of the analyst working with HPLC in QA/QC labs?
An associate chemist in U.S is one with a college degree? or is the same as applied chemical technician in Canada and Europe?(a post high school short course; 2 years).
Thanks
By Tom M. on Tuesday, May 13, 2003 - 12:52 pm:
There is no part of the CFRs that define the educational requirements of someone working in pharmaceutical QA/QC labs.
21CFR part 58.29 requires personnel have adequate education,training, and experience or any combination thereof necessary to perform the study. This is the requirement throughout the FDA guidance documents http://www.accessdata2.fda.gov/google/fda_search.pl?searchselector=&restrict=cder&q=education+training+experience&client=fdagov&site=fdagov&sa=+Go
It is common in pharmaceutical companies to have BA/BS requirements for entry level QA/QC positions. In US companies it is hard to tell from the title what the educational requirements of the position are. In one company an Associate Chemist might need a phd while in another company it could be a high school grad. If a position requires an associate degree or A.A., this is a two year post high school program.