Faculty: Meena Chettiar
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.
Based on Meena Chettiar’s vast experience in dealing with OOS results in pharma, food and medical device testing and questions raised on OOS in several FDA and regulatory audits, many practical examples will be presented from which you can lay a strong foundation for Successfully Dealing with Out of Specification (OOS) Test results in FDA Regulated Industries per the latest Guidance document.
The speaker will incorporate several examples based on the FDA Guidance Document for dealing with OOS Test results so you can integrate them into your company SOPs and ensure that your OOS investigations are able to withstand the strong audit scrutiny when you are questioned at FDA and other key audits of your OOS test results.
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.
Areas Covered in the Session :
The speaker has first hand experience dealing with FDA on OOS test results in food, pharma and medical device industries for over 25 years and hence will share her experience with several examples during this webinar.
Who Should Attend: