GOOD LABORATORY PRACTICE (GLP) SEMINAR (GLP SEMINAR)
Venue: Nippon Hotel
|Event Date/Time: Jul 05, 2007||End Date/Time: Jul 05, 2007|
|Early Registration Date: Jun 15, 2007|
•Quality Control staff
WHY TO ATTEND
•Good laboratory practice is a part of the total quality management system that any pharmaceutical company must have.
•In order to maintain a safe and efficient analytical laboratory there are many individual issues that must be monitored and controlled.
•In addition, should there be a potential problem with a product, in most cases the investigation starts in the analytical laboratory and certainly outside inspections whether government or client based fo concentrate on the functioning of the laboratory.
•Over the years various sets of rules have been introduced to help laboratories meet the expectations and these will be reviewed.
•In particular we will look at accuracy, integrity and traceability of data.
•One area that has received considerable attention is the requirement to have a system for dealing with results that are outside specification [OOS].
•The course will look at the new guidance and how an OOS should be established-the significant steps in carrying out an OOS investigation and a review of some audits in which OOS procedures featured.