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Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation
Thursday, January 17, 2013 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
The Clinical Laboratory Improvement Amendments (CLIA) training will outline the CLIA standards for frequency, methodology and also give examples of practical application.
Why Should You Attend:
The terms calibration, calibration verification and method validation are sometimes used interchangeably. The reality is that all of these are distinctly different processes and are all required by CLIA as related to medical laboratories. This presentation will explore the definitions, distinctions and rules of all three.
Areas Covered in the seminar:
- What do calibration, calibration verification and method validation mean?
- When each of these processes should take place.
- What systems are required to use these processes and which ones are not.
- Requirements for validation of new test systems.
- Remedial action if these processes are unsuccessful or have unexpected results.
- Reasoning behind each process and why they are necessary.
Who will benefit:
This webinar will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests. All automated non-waived systems fall under these regulations. Employees who would benefit include:
- Chemistry and special chemistry supervisors and techs
- Hematology and coagulation supervisors and techs.
- Blood bank supervisors and techs.
- Validation specialists
- Microbiology (automated) supervisors and techs
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.