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Limited Availability until January 2, 2025
This accredited course offers a streamlined overview of analytical method validation, focusing on key regulatory requirements set by ICH, USP, and FDA. Participants will gain practical knowledge of essential validation elements, including accuracy, precision, specificity, linearity, range, robustness, LOD/LOQ, and system suitability.
The course covers method development processes, from test selection and experimental design to the distinction between development and validation. Emphasis will be placed on writing up methods and creating standard operating procedures (SOPs).
Further topics include the validation process and application, such as product specifications, validation protocols, instrument qualification, and analyst training. The course concludes with statistical analysis of validation data, common acceptance criteria, and recommended approaches for setting criteria.
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 3: Process, Application, and Data Analysis for Analytical Methods Validation
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
ICH/USP/FDA Validation Requirements
Method Development
Method Validation Process and Application
Methods Validation Statistics and Acceptance Criteria
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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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