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ORA LABORATORY PROCEDURE Document No.: Version No.: …

FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS ORA LABORATORY Manual Volume II Document Number: Revision #: 02 Revised: 05/15/2019 Title: Personnel training and Competency Management Page 1 of 11 For the most current and official copy, check QMiS. Sections in This Document 1. Purpose .. 2 2. Scope .. 2 3. 2 4. 3 5. References .. 3 6. PROCEDURE .. 4 training and Competency Requirements .. 4 training Technique .. 4 Assessment tools .. 5 Demonstration of Competency .. 6 Authorization of Personnel .. 7 training and Competency Records .. 7 Retraining and Reverification .. 8 Retraining: .. 8 Reverification: .. 8 Required training .. 8 Facility Orientation .. 8 Agency-mandated training .. 8 New-Hire training often includes.

This training procedure is used to ensure that training has taken place with each employee for procedures and methods that the employee performs.

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