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Limited Availability until January 9, 2025
This accredited course provides a comprehensive overview of essential principles and practices related to method validation in regulated environments. The course covers key topics including revalidation, method revisions, and compliance issues in method validation. You will explore FDA-mandated updates, changes
in drug substance, product, method/site, and technology that require revalidation. Additionally, the course addresses common compliance challenges such as inadequate validation, robustness issues, errors in validation plans, and improper instructions (SOPs), as well as the importance of maintaining equipment and ensuring proper training to minimize non-compliance.
In addition, we will delve into life cycle management of analytical methods, examining real-world examples of method development and validation. Topics include a comparison of UHPLC vs. HPLC methods, ligand binding assays, and the application of advanced techniques such as LC-MS-MS.
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 3: Process, Application, and Data Analysis for Analytical Method Validation
Upon completion of this course, you will be able to:
COURSE OUTLINE
Revalidation and Method Revisions
Validated Method Compliance Issues
Life Cycle Management of Analytical Methods
Examples of Approaches to Method Development and 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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