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Selection and Use of (Certified) Reference Material in Analytical Laboratories
This training on using certified reference material in analytical laboratories will cover FDA and international requirements for selection, purchasing, testing, storage and use of (certified) reference material.
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, 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.
For easy implementation, attendees will receive
- 4 SOPs
- Handling (Certified) Reference Material
- Purchasing and Receipt of Supplies for Laboratories
- Quality Assessment of Laboratory Suppliers
- Preparation of Laboratory Working Standards
- Checklist: Handling (Certified) Reference Material
- 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
- Lab Supervisors and Managers
- QA managers and personnel
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 has authored 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, 21CFR Part 111, and validation around the world. This includes seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national healthcare agencies.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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Dr. Ludwig Huber
Understanding and Implementing USP <1058>: Analytical Instrument Qualification Change Control for Computer Systems - strategies and tools for FDA compliance Master Planning for Computer System Validation Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation