2011 - FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control

This seminar will discuss how to manage Out-of-Trend (OOT) results for FDA compliance.

Why to attend:

FDA requires trending test results and to intiate failure investigations and other steps in case of Out-of-trend (OOT) results. Well managed OOT results can also sinificantly reduce the number of Out-of-Specification (OOS) results. This seminar will discuss most recent FDA requirements and inspectional observations. It also will go into detail on what exactly to do in case of an OOT results. Attendees will receive a toolkit with SOPs, Case Studies and Examples for easy implementation.

Areas Covered in the Seminar:

* FDA regulations and guidelines
* 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, and failure investigations
* Examples: different types of case studies

Date: December 15,2011
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide (oder USA, nicht Germany, fall das möglich ist)

Who should attend
* Laboratory managers and supervisors
* GMP auditors
* QA/QC managers and personnel
* Qualified persons (for EU compliance)
* Analysts and other laboratory staff
* Regulatory affairs
* Human resources (HR) managers and staff
* Training departments
* Consultants

Weblink: http://www.labcompliance.com/seminars/audio/281/de...

Presenter: Dr. Ludwig Huber