USP Certificate of Document and Reference Standards
The USP Certificate of Document and Reference Standards provides prospect with the knowledge of the effective use of USP standards in the Pharmaceutical industry for the development and manufacture of medicines. Prospects will understand the legality and the science behind the standards, as well as the required industry collaboration in the revision process of the USP Standards. The certificate also provides best practices for the practical application of the USP–NF, USP–NF Supplements, Pharmacopeial Forum and USP Reference Standards - highly characterized chemical specimens.
There will be a knowledge assessment at the end of each course in this certificate. 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.
Upon completion of the USP Certificate of Document and Reference Standards, you will be able to:
Introduction to USP-NF:
- Find and use the sections, content, publication cycles, and official dates information found in the
USP–NF. - Discuss the regulatory status of the USP–NF
- Describe the proper use for the Pharmacopeial Forum in the Standard Setting Process
- Use the General Notices to more efficiently navigate the USP–NF
- Explain the General Chapters and their relation to monographs
- Describe the types of USP–NF monographs
Introduction to USP Reference Standards:
- Upon completion of this course, you will be able to:
- Explain Reference Standard changes over time (then to now)
- Describe the importance of the Reference Standard Development Process
- Determine why USP RS—Regulatory Directives are used
- Describe the proper use of USP Reference Standards
Target Audience
QC/QA personnel and management, regulatory compliance personnel and management, analytical scientist and workbench chemists responsible for quality assessments, regulatory agencies
Access Duration:Access to this course expires 2 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.