Course Description:
This course discusses in detail, with examples, the USP <41> requirements on balances and USP perspectives of Weighing on an Analytical Balance – USP General Chapter <1251>. The course is developed by USP liaisons with support from the USP Physical Analysis Expert Committee.
Through this course, the audience will achieve an accurate understanding of the requirements in the revised USP General Chapter <41>, USP perspectives on USP General Chapter <1251>, and good weighing practices.
Upon completion of this course, you will be able to:
- Outline the scope of <41>
- Understand the risk-based approach for qualification activities (calibration, performance checks)
- Explain the requirements of assessing balance performance according to <41>
- Understand the requirement of calibration and determination of measurement uncertainty
- Perform the repeatability assessment
- Calculate the minimum weight of analytical balances
- Understand the difference between minimum weight and smallest net weight
- Perform the accuracy assessment
- Outline the scope of <1251>
- Assess environmental impact on the balance performance and understand its mitigation
Who Should Participate:
- QA Staff
- Personnel who write SOPs for good weighing practices
- QC scientists
- Analytical scientists
- Formulators who conduct accurate weighing practices or use analytical balances
- Lab managers in charge of lab compliance
- Instrument specialists who conduct instrument operation/performance qualifications.
There will be a knowledge assessment at the end of the course. If this course is taken as part of the USP certificate program, you will be required to pass this knowledge assessment with a score of 80 percent to determine if your comprehension of the topics presented meets USP’s minimum requirements.
Access Duration:
Access to this course expires 6 months from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
USP Approved Instructor
Klaus Fritsch, Ph.D.