Overview: This session will discuss key considerations for Good Documentation Practices that would impact product quality, safety, efficacy and/or data integrity. Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed as the basis of documentation standards. It will also cover different types of records and how it would affect quality systems. Why Should You Attend: Documents are part of Quality Management System to record the information pertaining to a study or process. It demonstrates the integrity of the data collected. Most of the observations are based on poor documentation practices, thus the work can’t be reconstructed nor defended in an inspection. This session will cover the regulatory requirements of documentation and record management system.Areas Covered in the Session:Key factors of Documentation and Record ManagementRegulatory Expectations to DocumentationReview of Warning Letters and ObservationsTypes of Records in the pharmaceutical laboratoriesFundamentals of Good Documentation PracticesGlobalCompliancePanel Price: $225.00Phone: 800-447-9407Fax: 302-288-6884