analyticavietnam.com
Workshop - Understanding and Implementing ISO 17025
analyticavietnam.com
analytica-330-19_2The 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


vortrag_2About the Presenter
Ludwig 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).




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