Successfully Dealing with Out of Specification (OOS) Test results in the Pharmaceutical and Medical Devices Industry

Duration: 60 Minutes
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.
Out of Specification Test Results
Instructor: Meena Chettiar
Product ID: 501515
Objectives of the Presentation
  • 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.

Areas Covered
  • 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?
Who can Benefit
  • Quality Control Lab Technicians
  • Analysts, Scientists
  • Managers
  • QA personnel
  • Auditors in medical device and pharmaceutical industries
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Instructor Profile:
Ms. Chettiar has a very strong background in Quality in the FDA regulated industries. Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A. SC in Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar is also very knowledgeable in Clinical Research auditing for medical devices and pharmaceutical products.

Meena is currently working as a Senior Associate at NAMSA and is the Founder and Principle Consultant of MNQ Consulting Services LLC. Meena has worked as Quality and Regulatory Manager at ProMed Pharma, Medical and combination device manufacturer, a Senior Supplier Quality Engineer for Covidien with drug coated balloons and guide wires, for Baxter Bio Surgery, as a Senior Quality Manager at Teva Pharmaceuticals for over 10 years and as QC lab supervisor at Land O' Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years. Meena has performed mock QSIT Audits and has responded to several FDA 483s.

Meena has played a key role in quality system implementations in the food, pharmaceutical, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US, Canada, Puerto Rico and Costa Rica. Meena is the Chair elect for MNASQ (American Society for Quality) this year. Meena 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).

Meena has served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana and is very passionate about Installation and growth of Quality Systems in general.
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