This blended learning program consists of the full day live webcast and one (1) self-paced module which will be pushed to your education account prior to the live session.Course Description:This course will explore the nature of excipients and how they differ from active pharmaceutical ingredients and pharmaceutical finished products. An introduction to excipients and review of USP–NF General Chapters related to pharmaceutical excipients will be covered. An explanation of recent updates and developments to excipient GMP chapters will also be covered. Real-world scenarios will be used to apply USP General Chapters information along with some industry best practices and guidance.
Upon completion of this course, you will be able to:
- Demonstrate knowledge of what pharmaceutical excipients are and what they are not.
- Identify differences and diversities associated with pharmaceutical excipients.
- Describe reasons for using pharmaceutical excipients.
- Explain the significance of USP General Chapters relevant to excipients.
- Summarize important elements of:
- USP–NF General Chapters <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients
- USP–NF General Chapter <1195> Significant Change Guide for Bulk Pharmaceutical Excipients
- USP–NF General Chapter <1080> Bulk Pharmaceutical Excipients – Certificate of Analysis
Who Should Participate:
- Analytical scientists
- Excipient manufacturers
- Compounding pharmacy staff
- Quality assurance
- Quality unit personnel
- Pharmaceutical scientists
- Regulatory professionals
- Chemistry and manufacturing control Reviewers