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Equipment Validation 2021 - Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance



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Topics/Call fo Papers

FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision
Medical devices and pharmaceutical products must be safe and effective. Equipment used in assembly, test, or measurement must be able to be used for its intended purpose and result in a product that meets its required specifications.
Installation Qualification
Operational Qualification
Performance Qualification
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance

Last modified: 2021-05-31 17:54:34