Webinar Duration: 75 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Ludwig Huber

FDA’s guidance on OOS test results and the updated Chapter 6 of the EU GMPs require failure investigations and other steps for Out-of-Specification (OOS) and Out-of-trend (OOT) results. While most companies are familiar with and have procedures for OOS results, this is not the case for OOT situations. The guide states: “Although the subject of this document is OOS results, much of the guidance may be useful for examining results that are out of trend”. Managing OOT results also helps to avoid time consuming OOS results. The industry is unsure how to interpret and implement the FDA guidance and the EU GMP Capter 6 This webinar will give a good understanding of EU and FDA requirement and provide recommendations and tools for effective implementation.

For easy implementation, attendees will receive
– SOP: Handling OOT results
– Checklist: handling OOT situations
– SOP: Out-of-Specification Data Trending

Areas Covered in the Session:
– FDA regulations and guidelines
– FDA’s final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
– OOT requirements of the new EU GMP Chapter 6 on quality control
– Difference between OOS and OOT results
– Developing SOPs for OOT situations and laboratory failures
– Setting OOT limits
– Investigating OOT results: what and how
– Retesting of OOT results
– Using historical data for OOT evaluation
– Using QC samples and product control charts for evaluation
– Developing corrective and preventive action plans
– Finding the root cause for OOT results
– Strategies to avoid OOS situations BEFORE they occur
– FDA compliant documentation of OOS, OOT, failure investigations, root causes and CAPA
– Examples: different types of case studies

Who Will Benefit:
– Analysts
– Lab Supervisors and Managers
– QA managers and personnel
– Consultants
– Teachers

Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems, Informa Healthcare”. He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com