This 3-day course is designed to walk you through all aspects of the Method Validation Manager option in Empower. It is designed to logically follow the steps in the Method Validation Workflow Process from creating a validation method protocol to reporting and signing off validation results. This instructor led hands-on computer course guides the attendee through the topics

 Overview of Method Validation

• Definitions and purpose
• USP & ICH Guidelines
• 13 valdation tests
• MVM workflow
• MVM functionallity

Administering Method Validation Activities

• Project types
• Custom fields for MVM
• Default strings
• Sample editor
• Users and user types

Manager and Validation Review

• Validation protocol method
• Validation study
• Anatomy of validation review
• Anatomy of validation review

Validation Protocol Methods

• Creating a validation protocol method
• Configuring Validation Tests (i.e., linearity, repeatability, accuracy, etc)
• Approvals and singOffs
• Creating a sample set method

Workflow of a Validation Study

• Creating a validation study
• Adding or modifying tests
• Create or attach sample set method
• Create or attach samle set
• Create or attach result set
• Creating validation results
• Method validation test status

Viewing Validation Results

• Anatomy ofValidation review
• Common plots and tables
• Test specific plots and tables

 Reporting Validation results

• MVM report groups
• MVM composite groups

Method Validation Troubleshooting

Empower software users or managers who want to use, set-up or administer the Method Validation Manager to automate the entire chromatographic method validation process

MVM only works with the Empower Pro Interface.  Therefore, attendees must be familiar with Empower Pro Interface and know how to acquire process and print chromatographic data.  A basic understanding of method validation theory is assumed

Each attendee will receive a course manual to keep for future reference and a Certificate of Attendance.

För att utveckla kursverksamheten i Sverige har Waters från och med 2004 en heltidstjänst med ansvar att leverera kurser samt tillsammans med dig utveckla nya kurser utifrån dina önskemål.

Mats Johansson, tidigare serviceingenjör, har en bred kemisk och biologisk bakgrund. Tveka inte att ta kontakt med Mats om du har några funderingar om befintliga kurser, eller vid önskemål om kurser som idag inte finns i kursprogrammet.

För att på bästa sätt komma i kontakt med Waters Kursavdelning, sänd ett e-mail till vår kursadress: training_sweden@waters.com

eller ring: +46 8 555 115 00