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Dealing with Out of Specification (OOS) test results in the right way is a huge challenge to the pharmaceutical and medical device industry. FDA's Guidance Document to industry professionals for dealing with the OOS test result is very detailed but often not fully understood and interpreted as intended even by experienced laboratory professions. The 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 the first-hand experience in handling several OOS test results successfully during her experience as a senior QC Lab Manager and participating in successfully explaining her OOS approach at FDA, MHRA, ENVISAT, 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 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.

  • What exactly is FDA expectation for OOS?
  • When and at which stage can you confirm the OOS test result?
  • Does root Cause analysis aid at different phases of the investigation?
  • Retesting Guidance and requirements for different phases
  • How do you handle the 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

You should attend this webinar to dissect your OOS successfully and document it perfectly in your quality system. 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, known 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 can withstand the strong audit scrutiny when you are questioned at FDA and other key audits of your OOS test results. The speaker has 1st hand experience dealing with FDA on OOS test results in food, pharma, and medical device industries for over 20 years and hence will provide 1st hand experience with several examples during this webinar.

  • 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?

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

Meena Chettiar has worked as a Scientist for Health Canada and as a Quality Management Professional in food, pharmaceutical, and medical device industries for over 25 Years in Canada and the United States. During this time, Meena has had the opportunity to be audited by the US FDA several times and so is very proficient in FDA expectations in the regulated industry. She holds several certifications in Quality from the American Society for Quality (ASQ) and is currently the Chair of ASQ in MN, USA. 

As a Certified Senior ISO 13485 Auditor for Exemplar Global, Meena has performed several ISO audits in the United States and overseas. She is the co-author of Certified Bio-Medical Auditor (CBA) Primer for Quality Council of Indiana, ASQ Learning Institute registered instructor for CBA and has participated in developing the body of Knowledge for CQA and CSQP certifications. She currently works in Minneapolis, USA, in the Medical Device Industry. She also serves as an adjunct instructor for the master’s program in Medical Technology Quality and Regulatory Affairs for St. Cloud State University in their Plymouth facility. She has master’s degrees in Chemistry from India, Chemical Engineering from the University of British Columbia in Canada, and in Regulatory Affairs for Medical Devices from St. Cloud State University. 

In 2016, she received the MFEST (Minnesota Federation of Engineering, Science and Technology) Distinguished Science and Technology Professional Award. She has been presenting webinars in topics related to QA and QC in the FDA regulated industry for over 10 years.

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