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Limited Availability until March 18, 2025
This accredited course provides a comprehensive overview of key practices and regulatory requirements for method validation in pharmaceutical development. Focusing on data documentation, reporting, and compliance with FDA and USP guidelines, this session explores the essentials of experimental documentation, IND/NDA reporting, method verification (USP <1226>), and method transfer (USP <1224>). You will engage in workshops to develop validation plans and acceptance criteria. The course also covers FDA guidance on IND phase methods validation, highlighting timelines, real-world examples, and addressing common validation challenges.
Consider attending this course as part of the four-part series or as a stand-alone option for your personal career advancement and training. To deepen your understanding of analytical methods validation, the instructor recommends completing the entire series.
Part 1: Regulatory Guidance and Requirements for Analytical Methods Validation
Part 2: Development, Validation and Application for Analytical Methods
Part 4: Revalidation and Compliance in Life Cycle Management for Analytical Methods Validation
Upon completion of this course, you will be able to:
COURSE OUTLINE
Method Validation Data and Reports
Method Verification
Method Transfer
Methods Validation Workshop
IND Phase Methods Validation
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This course is tailored for professionals entrusted with ensuring the quality and reliability of pharmaceutical/biopharmaceutical products, medical devices, diagnostics, cosmetics, and food products.
Individuals working in Quality Control, Quality Assurance, Technical Operations, and Research and Development (R&D) departments stand to gain significant benefits.
Additionally, personnel involved in Regulatory Affairs and Regulatory Agencies responsible for reviewing quality data may also find this course valuable.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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