HCR and QM at the June DIA meeting

Dr. Antje Dahlen, QA Manager of Harrison Clinical Research, will be giving a talk on Quality management at this months DIA meeting in Boston, USA.

Her talk entitled "Knowing the system: Quality management according to ISO 9001", will be held on June 25 at 3-30 p.m. at the "Quality without compromise " session, chaired by Steven Steinbruech, President of Stonebridge GCP Consulting, Inc.

Dr. Dahlen will discuss effective QM systems and particularly ISO 9001:2000 and its implications on resource management, process approach, customer focus and continuous improvement. The inherent success of ISO 9001 is the capacity of the system to measure, analyse and continually improve the system and processes.

The summary of her talk can be found below. Dr. Dahlen looks forward to meeting you in Boston.

Knowing the system: Quality management according to ISO9001

The environment in which clinical research is carried out is very complex and governed by rules, local laws as well as sponsor and CRO requirements. Implementation of a Quality Management System facilitates adherence to the applicable rules and standardises the processes.
CROs and pharmaceutical companies may decide to create and establish either their own QM system or to adapt a standardized QM system such as ISO9001:2000.
This presentation will examine important principles of ISO9001:2000 applicable to a GCP environment within a CRO such as resource management (qualification and training), process approach, customer focus and continuous improvement.
The implementation of ISO9001 requires the support of top management, implementation of an independent QM department as well as quality objectives and QM tools for e.g. for corrective and preventative actions, as well as the definition and documentation of key and supporting processes in SOPs, definition of quality metrics and many more.
The inherent success of ISO9001 is the capacity of the system to measure, analyse and continually improve the system and processes.