Dealing with Out of Specification (OOS) test result the right way is a huge challenge to the pharmaceutical and medical device industry. FDA's Guidance Document to industry professionals for dealing with OOS test result is very detailed but often not fully understood and interpreted as intended even by experienced laboratory professions. Presenter of this webinar has over 20 years of experience in various industries (Food, Pharma and Medical Device) industries managing and responding to regulatory audits. The presenter has first-hand experience in handling several OOS test results successfully during her experience as senior QC Lab Manager and participating in successfully explaining her OOS approach at FDA, MHRA, ENVISA and PMDA audits. In this webinar, several practical scenarios will be visited so you can walk away with a clear approach to Successfully dealing with out of specification (OOS) Test results in the Pharmaceutical and Medical Devices industry right from confirmation of the OOS, investigation of the OOS in different phases and concluding the OOS satisfactorily so it can withstand scrutiny by regulatory bodies for years to come.

Course Objectives:

• What exactly is FDA expectation for OOS?
• When and at which stage can you confirm the OOS test result?
• Root Cause analysis aids at different phases of the investigation?
• Retesting Guidance and requirements for different phases
• How do you handle aberrant test results?
• When can you and should you call an OOS investigation inconclusive?
• Strategy for reporting the final result (which test results can be averaged?
• Why testing into compliance is a major mistake that must be avoided?
• Minimizing time spent on OOS investigations and maximizing throughput in your laboratory testing during investigative testing for OOS

Why Should You Attend:

Dealing with OOS presents a major challenge to several laboratories. Successfully interpreting regulatory expectations in this area and practically dealing with OOS results from USP, non USP chemical, microbiological and physical test measurements will be described in this valuable webinar. Several practical examples will be presented from which you can lay a strong foundation for "Successfully Dealing with Out of Specification (OOS) Test results in the Pharmaceutical and Medical Devices Industry" in your company and incorporate the examples or lessons learned 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 webinar to dissect your OOS successfully and document it perfectly in your quality system.

Course Outline:

• FDA Guidance document for dealing with OOS, its intention and its applicability
• Various challenging OOS scenarios and how can one deal with them successfully
• QA/QC responsibilities in dealing with OOS
• Resampling and retesting requirements for different phases of OOS
• What is expected for successful handling of OOS during measurements, product release and in follow up audits?

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Control Lab Technicians
• Analysts, Scientists
• Managers
• QA personnel
• Auditors in medical device and pharmaceutical industries