Faculty: HitendraKumar Shah | Code: FDB3520
Out of Specification (OOS) Test Results presents a major challenge to several in house and contract testing laboratories as FDA and other regulatory agencies’ expectations in this area are very rigid and specific. Successfully interpreting regulatory expectations in this area and practically dealing with OOS results for pharmaceutical, cosmetic, Vitamins, minerals and supplements and medical device industry based on USP, non USP chemical, microbiological and physical test measurements will be described in this presentation. You should attend this presentation to dissect and deal your OOS test results successfully, and document it perfectly in your quality system and avoid unnecessary 483’s in this area.
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Who Should Attend: