Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements
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Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements Course
Introduction:
What you should know about the needs of the regulators
CDS - 1 validation: the essentials
CDs - 2 validation: specification and selection
Third-party vendor audits for CD validation
Qualification and reporting of the validation effort for CDS - 4
Creating pq tests for the validation of CDS - 4
CDS - 5 validation: preserving the validation
Course Objectives:
The easy part of CDS validation is a concept to operational release. The most difficult part is maintaining the validation status of your system through its operating lifetime of many years. This represents the greatest regulatory risk - so what do you have to do to ensure continued compliance? Establishing and maintaining the validation status of the system over its lifetime: backup, change control, configuration management, and disaster recovery. How to archive and approach ready recovery of electronic records and metadata So now you think you are compliant? The role of central IT in maintaining the validation status of a CDS.
Who Should Attend?
- Chromatographers in the Pharmaceutical and Medical Device Industries; contract research organizations that use chromatography data systems requiring validation; chromatographers working in laboratories accredited to 21 CFR 11 (FDA); quality assurance professionals responsible for ensuring compliance with regulations;
- information technology professionals responsible for supporting these applications in a regulated or accredited environment.
- Level of the Course: Experienced chromatographers who know how to use a data system but do not know much about the validation of the data system; chromatographers who want a reality check of their current approaches.
Course Outlines:
The regulator's requirements - what you need to know
- The fundamentals
- specification and selection
- vendor audits
- qualification & reporting the validation effort
- designing PQ tests
- maintaining the validation