Auditing the QC Microbiology Laboratory for FDA Compliance

This microbiology laboratory training will provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance, test failures and resolution of audit findings.

Why Should You Attend:

Microbiology analytic testing is designed for the detection of pathogenic and non-pathogenic microorganisms that are prevalent in materials subject to human and animal exposure, and in the environment. In order to ensure safety and hygiene the testing procedures and the laboratories where they are performed are impacted by defined regulatory guidelines at non-clinical testing and manufacturing facilities.

An important aspect of compliance includes periodic internal and external inspections to ensure the enforcement of quality policies. These regulatory requirements broadly comprise management systems that enforce rules and monitors standard operating procedures, methods validation, organizational structure, qualifications and training of personnel, facilities, biosafety precautions, equipment validation and performance, reagent certification, document control including the recording, reporting, and archiving of information, and laboratory information management systems (LIMS). Preparation for inspections is a fundamental aspect of routine operations.

This webinar based on FDA guidelines will provide a comprehensive overview of the infrastructure of a compliant microbiology testing laboratory, preparation for an inspection, potential areas for nonconformance, test failures, resolution of audit findings, and examples of issuance of 483s and warning letters.

Event Details:

Date: October 17, 2012
Time: 10:00 AM-11:15 AM PDT
Cost: $299 per attendee per computer terminal
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