Dealing with Out of Specification (OOS) Test Results

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 Will Benefit:

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

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Meena Chettiar

Meena Chettiar currently works as a Quality and regulatory Manager at ProMed Pharma in Minneapolis. Meena has worked as a Senior Supplier quality engineer at Covidien, Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Control Manager at Teva Pharmaceuticals for over 10 years and as Instrumentation lab supervisor at Land O’ Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years before immigrating to the United States.

Meena made the transition to the medical device industry after completing a MS in Regulatory Affairs for Medical Devices through St. Cloud State University in 2010. Meena has played a key role in quality system implementations in the food, pharma, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several Compliance audits in the US and abroad. She has a strong auditing background in the pharmaceutical and medical device auditing. Meena is a senior member of ASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence). She has been serving as an instructor for these ASQ certification classes since 2006 and has conducted quality and medical device related training classes in her current position at Baxter.

Meena is a coauthor of the CBA (Certified Biomedical Auditor) primer for the Quality Council of Indiana. She is currently an adjunct instructor for the medical technology quality program at St. Cloud State University in Minnesota. Ms. Chettiar received her M.S Regulatory Affairs and Services for Medical Devices from St. Cloud State, Minnesota, M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is happy to teach webinars for the Compliance Trainings and continue to contribute towards quality and regulatory compliance.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.