
The program of the workshop was dedicated to quality and laboratory
management and provides an excellent opportunity to middle and senior
management of all private and public organizations seeking or
maintaining ISO 17025 accreditation. The workshop gave attendees
the background to understand the requirements and even more importantly
it focused on strategies and provided tools to implement critical
requirements. Practical examples and interactive exercises have been
dispersed into and between the presentations. About 50% have been
dedicated to practical sessions with life examples.
Following have been the topics of the workshop:
• Benefits and scope of ISO 17025
• Accreditation processes and procedures in Asia, Europe and United States
• Management requirements
• Organizational requirements
• Corrective and preventive actions
• Control of records
• Technical requirements
• Calibration, sampling, assessment of supplies and subcontractors
• Validation of analytical methods and procedures
• Documentation requirements
• Steps towards ISO 17025 laboratory accreditation
• ISO 17025 and the FDA
• Recommendations for implementation
• Dealing with multiple quality systems
• Possible pitfalls and how to avoid them
• Preparation for an ISO 17025 audit
• The role and responsibility of laboratory suppliers
• Going through an example quality manual
• Going through example procedures
Target Audience• Food, chemical, environment, clinical and pharmaceutical testing laboratories
• Directors
• Laboratory managers, supervisors and senior analysts
• QA managers and personnel
• Consultants
• Laboratory suppliers of material, equipment and services
• Suppliers of laboratory equipment and materials
About the PresenterLudwig Huber, Ph.D., is Director for global FDA compliance at
Labcompliance. He is the author and editor of www.labcompliance.com,
the on-line resource for validation and laboratory compliance and Chief
Compliance Advisor for Agilent Technologies. He is also the author of
ISO 17025 Accreditation Package
and of the books „Validation of Computerized Analytical
Systems“ and „Validation and Qualification in Analytical
Laboratories“, Interpharm Press 2002 and 2007. He has been a
team and review member of PDA`s task force „Validation of
Laboratory
Data Acquisition Systems“. He also is on the executive advisory
board
of IVT Journals and of the European Compliance Academy (ECA).