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Date: 3rd - 4th December, 2012

Location: Berlin, Germany

Summary:
Pharmaceutical - Training

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 methodology. Special attention will be paid to the critical compliance aspects of gathering pre-clinical data in a regulated environment.

Also included is a discussion of functions related to quality assurance unit responsibilities and the need to effectively audit 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.

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