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.
Areas Covered in the Session :
- FDA Guidance document for dealing with OOS, its intention and its applicability
- When and at which stage can you confirm the OOS test result?
- Root Cause analysis aids at different phases of the investigation?
- Various challenging OOS scenarios and how can one deal with them successfully
- QA/QC responsibilities in dealing with OOS
- Resampling and Retesting Guidance Requirements for different phases of OOS
- How do you handle aberrant test results?
- When can you and should you call an OOS investigation inconclusive?
- Strategy for reporting the final result
- Minimizing time spent on OOS investigations
- What is expected for successful handling of OOS during measurements, product release and in follow up audits?
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Laboratory Staff
- Quality Analysts and Technicians
- Regulatory Affairs Departments
- Training Departments
- GMP Auditors