ECA - New USP & FDA Approaches for HPLC

Art-No.: A-918
Date: 13 - 17 Mai 2018

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
11690Introduction: Overview of HPLC in a GMP Laboratory016
11691Sampling Practices and Pitfalls for HPLC Analysis060
11692QbD and Lifecycle Approach to pharmaceutical analysis012
11694Method Design and understanding026
11695Workshop 1: From analytical target profile to HPLC assay performance criteria04
11696Translating from traditional to fast Chromatography030
11697Out of Specification HPLC results026
11698Risk Based HPLC instrument Qualification027
11699Metrics for HPLC Data Integrity025
11700Integration and Interpretation of HPLC chromatograms030
11701Workshop 2: HPLC Instrument Qualification04
11702Validation and Verification of HPLC procedures020
11703EP and USP system suitability requirements for HPLC039
11704Workshop 3: Common Method Validation Problems and how to troubleshoot them02
11705Second person Review of HPLC Analysis including Audit Trails032
13128Ensuring HPLC and CDS data integrity031
13129Reference Standards for HPLC027
13130Practical Interpreatation ofelectronic records for a CDS013
13131Effective Analytical Method Technology Transfer035
13132Risk Based Validation of a CDS including Implementing Electronic Signatures for Productivity038
13133Workshop 5: Identifying the common pitfalls in the validation of a chromatography data system03
13825Workshop 4: HPLC System Suitability Tests016

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