2011 - Good Laboratory Practice Regulations: Introduction and Strategies for Implementation

Why to attend:

Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, or what procedures are required and how to implement GLP regulations. This seminar gives a good understandibng of GLP requirements. Attendees will receive toolkits such as SOPs and Examples for easy implementation.

Contents:
* FDA and International GLP regulations: 21 CFR Part 58, OECD
* Examples for FDA 483 inspectional observations and warning letters
* Special organizational requirements
* Responsibilities: Management, Study director, QA, analysts
* SOP requirements: type, formats and enforcement
* Conducting studies: preparation, implementation, documentation
* Key requirements for equipment, facilities reference material, people
* GLP compliant data generation and evaluation
* Records keeping: format, length of time, archiving and reprocessing
* Strategies for Multi-site GLP Studies
* Preparing for FDA inspections

Date: September 22,2011

Who should attend
* Lab Supervisors and Managers
* QA managers and personnel
* GLP auditors
* Analysts
* Consultants
* Teachers

Weblink: http://www.labcompliance.com/seminars/audio/275/de...

Presenter: Dr. Ludwig Huber