Handling OOS Test Results As Per Latest FDA Guidance -2022

Out of Specification (OOS) Test Results presents a major challenge to several in house and contract testing laboratories as FDA and other regulatory agencies’ expectations in this area are very rigid and specific. Successfully interpreting regulatory expectations in this area and practically dealing with OOS results for pharmaceutical, cosmetic, Vitamins, minerals and supplements and medical device industry based on USP, non USP chemical, microbiological and physical test measurements will be described in this presentation.

Based on Meena Chettiar’s vast experience in dealing with OOS results in pharma, food and medical device testing and questions raised on OOS in several FDA and regulatory audits, many practical examples will be presented from which you can lay a strong foundation for Successfully Dealing with Out of Specification (OOS) Test results in FDA Regulated Industries per the latest Guidance document.

The speaker will incorporate several examples based on the FDA Guidance Document for dealing with OOS Test results so you can integrate them 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 presentation to dissect and deal your OOS test results successfully, and document it perfectly in your quality system and avoid unnecessary 483’s in this area.

Areas Covered in the Session :

The speaker has first hand experience dealing with FDA on OOS test results in food, pharma and medical device industries for over 25 years and hence will share her experience with several examples during this webinar.

• 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
• Core responsibilities of Personnel involved in testing, releasing and receiving FDA regulated products
• Acceptable path forward on encountering aberrant OOS test results
• FDA Guidance document on dealing with out of specification/failing test results
• Understanding do’s and don’ts of retesting as per latest guidance
• Criticality for product release
• What is allowed and what is not
• Areas to be looked at for a thorough investigation

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Research and Development Departments
• Quality Control Inspectors
• Quality Control Lab Technicians
• Scientists working in Testing labs in food, pharma and medical device industries
• Compliance auditors in FDA regulated industries
• Everyone working in FDA regulated industries involved in testing, releasing products and accepting products at all levels.

Course Director: 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.