EFFECTIVE FAILURE
INVESTIGATION

Conference Date: 08-09 Dec 2009
Conference Ref: M12-6209
Fee: £1080 + VAT
Venue: Harrington Hall Hotel, London

OVERVIEW

The results from the analysis of ‘Warning Letters’ arising from FDA systems based inspections for their fiscal year 2004 (October 2003 - September 2004) indicates two very clear points:

• The most frequently cited aspect in ‘Warning Letters’ over this period is failures associated with CFR §211.100 (Written Procedures; deviations)

• Although the number of ‘Warning Letters’ issued in the FDA’s last fiscal  year is less than the previous year, the number of ‘Warning Letters’ issued to Pharmaceutical Companies outside of the US has increased.

Similarly, recent events in Europe have indicated that the Agencies also have concerns in respect to the investigation of failure (deviations), their subsequent correction and what actions are instigated to prevent their reoccurrence.

It is recognised that one of the most important elements in the Quality System itself is the effective evaluation, investigation, correction, prevention and monitoring of deviations/failures during the manufacture of a pharmaceutical product.

Management Forum have brought together two Consultants who are recognised for their expertise in the area of failure investigation. Through discussion and the use of workshops, they will review how a failure investigation system should be organised, what methods can be used in the investigation of failure, what a Corrective and Preventative Action (CAPA) system should look like and how to effectively monitor, follow-up and close out CAPA’s.

Click here to book your place on this important Annual Event.