Effectively Using Reference Standards

Course Title:

Course Description:

The course will make extensive use of the USP General Chapter <11>, the European Pharmacopeia General Chapter 5.12, the ISO-REMCO Guidelines, and the FDA documents on Reference Standards. It will stress the growing significance of statistics in modern metrology, and it will discuss the importance of international harmonization and of the collaboration with other standards–setting organizations. The correlation between Reference Standards and Compendial Methodology will be discussed in the context of the development, characterization and uses of the materials. All concepts presented in the course will be exemplified with real-life cases.

Who Should Attend:

Scientists and quality control staff employed at Pharmaceutical manufacturers (innovators and generic), regulatory agencies, contract laboratories, manufacturers and distributors of dietary supplements, compounding pharmacies, FCC users.

Duration:

One-day lecture only

Learning Objectives:

Gain a better understanding of the process of establishing USP Reference Standards
Connect the use of USP reference standard materials to the efficient use of in–house working standards
Be able to promote a closer cooperation with USP and your organization

Contact Information:

pharmed@usp.org

Product Sheets

Effectively Using Reference Standards