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Compliance: Analytical Labs


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Building in Compliance in the Analytical Laboratory:
Lab Bench to Market Production 

Approximate Time: 2 hours

Who Should Attend:

This course is designed to provide an overview of issues regarding GMP compliance in an Analytical Laboratory setting.  Topics will cover specifics to consider to support all phases of drug development. Personnel in QA, QC, Regulatory, and Analytical Development involved in ensuring laboratory GMP compliance should attend. Course assumes the attendee has a basic understanding of the GMP regulations. 

Course Description: 

Analytical Laboratories play a critical support role to manufacturing products.  Test results must be reliable even at the earliest phases of development.  This course discusses a phased in approach to GMP compliance that will provide reliable test results to support process development and process validation and will lead seamlessly to a fully validated, fully compliant laboratory by the time late phase Clinical Trials materials are being tested.  Course Topics include:

bulletRegulatory Requirements 
bulletTesting to Support Process Development 
bulletTesting to Support Clinical Manufacturing 
bulletTolerances and Uncertainties 
bulletAssay Qualification/Validation 
bulletTechnology Transfer 
bulletQuality Assurance Involvement


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FDA on Methods Validation

While analytical methods performed to evaluate a batch of API for clinical trials may not yet be validated, they should be scientifically sound.

November 2000
Section 19.80

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