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Good Laboratory Practices for Pre-Clinical Testing
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This three-day GLP training course is designed for all Scientists (managerial and laboratory), Regulatory Affairs and Compliance personnel who are active in regulated laboratory studies. It will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance and submission of laboratory data to regulatory agencies. Principal Investigators, Study Directors, Study Monitors and professionals aspiring to these positions will derive benefit from this course.

4/13/2015 to 4/15/2015
When: April 13-15, 2015
Where: Desmond Hotel and Conference Center
Malvern, Pennsylvania 
United States
Presenter: The Center for Professional Innovation and Innovation
Contact: 855.752.9320

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Good Laboratory Practices (GLP) for Pre-Clinical Testing

Good Laboratory Practices (GLP) generally refers to a quality system of management controls for laboratories and research organizations that regulates how non-clinical safety studies are planned, performed, monitored, recorded, reported and archived. Many Bioanalytical laboratories have also chosen to follow GLP as the quality system for the control of testing for pharmacokinetic and other clinical studies. This ensures the consistency and reliability of results for submissions to the USFDA, the OECD and other national organizations.

This three-day GLP training course is designed for all Scientists (managerial and laboratory), Regulatory Affairs and Compliance personnel who are active in regulated laboratory studies. It will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance and submission of laboratory data to regulatory agencies. Principal Investigators, Study Directors, Study Monitors and professionals aspiring to these positions will derive benefit from this course.

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.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

 

Learn more about the course and register.


CfPIE is a preferred provider and offers MichBio members a 15% discount on course registration fees. Click here for more information.

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