Course Description:This course integrates ICH Guidance and FDA policy for impurities, relevant USP General Chapters about impurities, and USP’s approach to impurities in monographs. It also provides insights to USP‒NF General Chapters <476> and <1086> and include case studies for impurities in the development and revision of USP monographs.
Upon completion of this course, you will be able to:
- Discuss the origin and classification of impurities in pharmaceuticals.
- Explain global guidance's for impurities.
- Describe the USP approach to impurities in drug substances and drug products.
- Discuss the USP general chapters on impurities.
• - Explain the USP approach to harmonization across pharmacopeia.
- Demonstrate knowledge of USP’s approach for impurities in documentary standards via case studies.
Who should participate:
- Analytical scientists
- QA/QC
- Formulators,
- Manufacturing scientists
- CMC submission and review scientists
- Regulatory professionals
COVID-19 Policy:For Classroom registrations, onsite attendees must be
fully vaccinated, as defined by the CDC, adhere to CDC guidelines on social
distancing, and state, local and USP mask requirements. We will continue to
monitor the COVID-19 pandemic as the course date approaches, and there is a
possibility that the in-person Classroom offering will be cancelled. If
this occurs, we will offer the option for a full refund or we can transfer your
registration to the virtual option. Registration Cancellation/Refund Policy: A USP Education course may be cancelled due to lack of enrollment, inclement weather or other unavoidable factors. In the event of a course cancellation for such reason, USP will provide a full refund to all registered participants. We will do our best to provide at least a two (2) week notice for classroom course cancellations. Please know that the USP-US office follows the closing policy of the federal government in the Washington DC metro area which can be checked here.