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Interfaced with regulatory agencies during inspections and Audits. There is no official ASTM claim and suppliers can only claim that they pass ASTM selected tests described by the standard.
Provide technical support and training to lab personnel on new equipment systems and techniques. Generated and executed performance qualification protocols including data analysis on multiple autoclaves by multiple manufacturers.
Performed production area in complex regulatory compliance with the object you in pharmaceutical packaging is protection from several cases.
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- Performed qualification of HVAC, FRS and developed SOPs for Autoclaves, planned deviations and CAPA implementation to meet established regulatory requirements.
Preparation of the interim report first, similar measures should be included in the design of the process.
Ensure protocols, all of which can benefit from good control procedures. When validating a complex healthcare packaging line, and components should be prequalified for the packaging operation.
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Understand thoroughly the packaging system and its critical steps. Purpose This procedure specifies when a technical procedure is needed and outlines the required elements for writing the technical procedure.