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- Method Development Strategies for Impurity Control in Late-Phase API Manufacturing
- NEW! Accompanying White Paper
Learn how to navigate the regulatory landscape utilizing current method development technologies for impurity control in late-phase API manufacturing. We will review the application of various laboratory techniques, including LC, LCMS, GC, ICP-OES/MS, and other methodologies. We will consider the advantages and challenges posed by each analytical technique and:
- Provide an understanding of the regulatory landscape for impurity control and late-phase APIs.
- Review of the analytical technologies used for impurity assessment.
- Examine method development and validation strategies.
Key Learning Objectives
- An understanding of different method development approaches.
- How to select the proper analytical technique for the separation.
- How to approach challenging separations.
Who Should Attend
- Chemistry Manufacturing Control (CMC) and regulatory leaders.
- Analytical scientists working in method development.
- Scientists with interest in the determination of API impurity control.
- Scientists with an interest in HPLC or GC separations and mass spectrometry.
Reviews of the Webcast
“I learned a lot of new relevant information – the speaker and slides were great.”
“…Enriched my knowledge about method development.”
“The speaker clearly is knowledgeable and comfortable with the topics presented and discussed.”
“I appreciated the speaker’s knowledge and use of real-life examples he’s worked on…”
- Genotoxic Impurities (webinar)