Why Should You Attend: This course is designed to provide participants with an understanding of the USP, including both the organization and the published standards, and strategies for assuring conformance to USP standards. The course will cover the major USP publications, the type of content in each and regulatory expectations regarding their use.
In addition, the course will cover when deviations from the published standards are acceptable, and the mechanisms for being aware of pending changes to the USP, and how to influence the changes.
The speaker will actively solicit questions from the participants and address them by the end of the webinar.
Duration: 4 hours of instruction, and breaks as appropriate.
Learning Objectives: Upon completion of this course the learner should be able to:
- Understand the USP, including the organization and information it provides, and the relationship to FDA.
- Be familiar with the sections of the USP/NF, including General Notices, General Chapters and Monographs.
- Use USP procedures and reference standards as provided, and be aware of alternative options.
- Understand that the PF is the primary communication tool used by USP to inform the public of changes, and that it is now readily available for free.
- Know how to influence the USP and be aware of current Hot Topics
