Live Air Date: Wednesday, September 24, 2014
Deploying an Enterprise Chromatography Data System in your laboratory is a major undertaking. Not only should you design the architecture to support the deployment, but you need to design good, robust SOPs for all aspects of data integrity: IT SOPs for data security, analyst SOPs for secure data creation, and reviewer/manager/QA SOPs to ensure that all data from all tests are reported and reviewed before official release of product.
A number of key deficiencies in this review process have been identified by pharmaceutical regulators in the last two years which challenge the quality and accuracy of test data. In this webinar we will review these deficiencies and how to address them.
As an attendee, you will learn more about:
- What the US and EU regulators will ask about data integrity in your CDS data.
- What data they will want to see and in which format.
- The need to demonstrate that your robust review SOPs examine data to the same level of detail as the forensic investigation in a regulatory inspection.
- The typical deficiencies you need to consider when reviewing CDS data and how to address them.
Speaker
Heather Longden is the senior marketing manager for informatics and regulatory compliance at Waters. Heather's current role is as a specialist in compliance to e-record regulations, acting as a resource to the global informatics community at Waters and the users of all Waters Informatics products. This involves helping design the compliance into our Informatics products and services, attending and presenting at specialist conferences, keeping up to date on the latest interpretations and amendments to the regulations and disseminating this information to the Waters field and corporate organizations.
Sponsor
