This seminar deals with assembly of technical documentations and gives advices for
compliant documentation structures required within quality management systems.
Furthermore generation of stability data for identification of expiry dates is illustrated.
Technical Documentations typify total documentation data for medical products and are
obligatory for quality assignment and approval. Therefore every medical product has
to possess such a documentation compilation. Here completeness and correctness of
technical documentations is important because this file is subject of investigations of
authorities responsible for quality assignment (CE label) or approval.
Prospective project managers dealing with technical documentations, especially quality
managers, have to consider presence and completeness of this management file. Here
responsible person often acts as contact person for audits of local or global authorities.
This seminar deals with assembly of technical documentations and gives advices for
compliant documentation structures required within quality management systems.
Furthermore generation of stability data for identification of expiry dates is illustrated.
