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:
- Describe the types of USP–NF monographs
- Explain how the USP–NF is used to include sections, content and regulatory status, publication cycles, and official dates
- Describe the proper use for the Pharmacopeial Forum Notices
- Explain the General Chapters and their relation to monographs
Introduction to USP Reference Standards:
- 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.