Selection and Use of (Certified) Reference Material in Analytical Laboratories

This webinar will provide an in-depth understanding of anti-kick back and stark laws, and discuss how marketing activities can trigger either or both. It will show how to implement mandatory internal controls to reduce exposure to risks.

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.

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
• Analysts
• Consultants