Good-Life-Science-Practices, Validation and Risk-Assessment
supported by HTML-based Process Documentation

Our presentation (lecture) will show special requirements located to pharmaceutical (process-) documentation, like these take place e.g. in context of GxP validation (good life science practices). Official examinations, the clear context of pharmaceutical work flow, production and logistic-alter-natives will be the main focus of all (FDA-) Inspections.
Frequently we have to accept only little free capacities and/or resources in medium-sized enterprises; in order to fulfill regulatory requirements “additionally” to daily events; rising costs, temporal or personnel bottlenecks must be considered. At the same time customers place highest requirements into the quality of the products. Own Business Management concurs with long lasting prevention requirements to provide late reaction.

In-plant processes will be brought together e.g. in accordance with the Businesses Process Modeling notation (BPMN, holistic open standard for the modeling, implementation and execution of business processes) into comprehensive reports. The admission of the business processes takes place gradually or stepwise, according to responsibilities or to refer field-activity. All individual elements are assigned by applicable documents. The depth of the documentation takes place in relation to the risk-assessment-analyses.

from office binder ...

to HTML-Documents!

 This lecture (see here or print-version ) had been part of
"Medical Conference, Cardiology, Pediatrics, Surgery and Medical Techniques -

© 2006-11-01 (vW)

November 2 – 11, 2006 in University of Damascus, Homs, Aleppo (Syrian)