Laboratory equipment validation is the latest conference stream to be announced at Lab, the new European trade fair and conference devoted to analysis, bio and laboratory equipment
Laboratory equipment validation is the key to ensuring reliable results, and the topic raises many questions about laboratory procedures, which will be debated throughout the day.
Organised by Leipziger Messe, the conference stream will be chaired by Penelope Bearne, chairman of the British Association of Research Quality Assurance (Barqa), and will take place on 2 October 2007.
From establishing operational qualification (OQ) and installation qualification (IQ), the conference will examine issues raised by ISO 17025: Testing and calibration laboratory requirements (formerly known as ISO 9002 Guide 25), featuring presentations from industry specialists which will facilitate discussion from an expected audience of about 250 people.
Penelope Bearne comments: "I am pleased that Lab 2007 will be hosting a conference stream dedicated to laboratory equipment validation, and that Leipziger Messe recognises it as an area that should be on the public agenda.
"We are going to see the key issues in this area discussed by some of the most experienced people in the industry during the day, and we aim to move some important debates forward".
The conference will examine the following areas of laboratory equipment validation.
Designing effective validation protocols: examining the requirements of an effective protocol through to developing templates, writing and executing.
Roles and responsibilities of vendors and laboratories in validation processes.
Selecting the right supplier and developing the vendor assessment process, determining the type of assessment, preparing and reporting the findings.
Validation and qualification of laboratory IT and computer systems, from audit trails and data archiving to maintaining network qualification and security requirements.
Maintaining validation throughout the instrument lifecycle from procurement planning to decommissioning.
Dealing with validation auditing, including practical approaches to the audit process, the regulators approach to audits and preventative procedures.
Risk-based qualification and systems validation, from applying Gamp (good automated manufacturing practice) to tools for equipment validation.
Understanding and responding to the regulatory environment, evaluating FDA (Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) expectations and strategies to mitigate immediate compliance risks.
Bearne continues: "The variety of subjects being presented throughout the day shows how much progress is being made in the area of validation, but also the number of issues that are currently being raised by professionals in the laboratory sector.
"I am particularly looking forward to the discussions on effective validation protocols and regulators' expectations within this challenging field".
The biennial Lab is taking place at Excel London international conference and exhibition centre from 2-4 October 2007, and will provide professionals from a diverse range of industries with the chance to attend specialist presentations, meet with manufacturers and network with industry colleagues.
