Looks like this event has already ended.
Check out upcoming events by this organizer, or organize your very own event.
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
Thursday, November 15, 2012 from 10:00 AM to 11:15 AM (PST)
Palo Alto, CA
This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.
Why Should You Attend:
FDA's guidance on OOS test results requires 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.
This session will equip you with the knowledge and comprehensive understanding of FDA requirements for Out-of-Trend Results in pharmaceutical quality control.
For easy implementation, attendees will receive
- Handling OOT results
- Handling OOS results
- Out-of-Specification Data Trending
- Checklist: Handling OOT Situations
Areas Covered in this Webinar:
- FDA regulations and guidelines.
- FDA's final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
- Difference between OOS and OOT results.
- Developing SOPs for OOT situations and laboratory failures.
- 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.
Date: November 15, 2012
Time: 10:00 AM-11:15 AM PDT
Cost: $299 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.