Good Lab Practices (GLP) for Pre-Clin Testing

Berlin, Germany

This course will provide participants with a comprehensive understanding of the terminology, regulations and mandated practices for GLP testing and compliance. Those attending will get a thorough briefing of the relevance of accurate documentation, calibration and maintenance of instruments and validation of relevant methodologies. 

The course also covers in detail issues involving the roles and responsibilities of the Study Director in planning, supervising and managing pre-clinical studies. Also, the analysis and reporting of study results will be discussed. Also included is a discussion of functions related to quality assurance unit responsibilities and the need to effectively audit laboratory activities and data for regulatory compliance. Successful audits are often a result of good planning and interaction between QA staff and management. This course will cover a range of audit activities (internal and external) including responsibilities and requirements for compliance including those required at collaborator sites, records management, GLP special requirements, archiving of data and inspections.

The roles and responsibilities of Quality Assurance in the control of daily activities, data collection, analysis and archiving of study information will be discussed. The roles of the Study Director and QA in regulatory and client inspections will also be presented.

The course also discusses how to manage regulatory inspections, and how to respond to regulatory findings and audits. Inspection results for sponsoring companies and CROs are included in these discussions.

Více: http://www.cfpie.com/ProductDetails.aspx?ProductID=207