Selection and Use of (Certified) Reference Material in Analytical Laboratories
Instructor:
Dr. Ludwig Huber
Product ID: 702550
- Duration: 75 Min
Why Should You Attend:
Most important for getting correct analytical results is the use of accurate standards or (certified) reference materials. No matter how skilled the analysts are or how sophisticated and automated the equipment is, if the calibration of the system is incorrect, the analytical result will always be wrong. Because of this FDA inspectors expect companies to have validated processes for the selection, purchasing, testing, storage and use of (certified) reference material.
This webinar will cover FDA and international requirements for reference material used in analytical laboratories. We will discuss practical approaches that you can implement for the selection, purchasing, testing, storage and use of (certified) reference material.
Learning Objectives:
- The role and importance of reference material in chemical measurement
- FDA and international requirements
- Requirements of ISO 17025 and ISO 34
- Official and industry guidance documents
- Hierarchy of reference material
- Preparation and Testing of Certified Reference Material
- Traceability of primary/secondary standards and reference material
- Preparing working standards from primary and secondary standards
- Developing an SOP for preparation of working standards
- Assessment of suppliers of reference materials
- Practical approaches for qualification of incoming material
- Optimizing the uses and the costs of reference materials
- Documentation for the FDA and ISO
Who Will Benefit:
Pharmaceutical development companies, API manufacturers and contract laboratories will benefit from this training. Personnel who will benefit include
- Analysts
- Lab Supervisors and Managers
- QA managers and personnel
- Consultants
Dr. Ludwig Huber
Director and Chief Editor, Labcompliance
Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.
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