Waters Data Integrity Seminar Turkey


  • Overview
  • Venue
Date(s): October 17, 2017
Time: 08:30-16:00
Location: Istanbul
Language: English

Waters and Likrom invites you to our free seminar to learn how you can increase your workflow efficiency, develop best practices and preserve the quality of your data throughout the data life cycle.

Managing electronic data and chromatography data systems has introduced new challenges to the modern laboratory. With companies under increased security by regulatory authorities, lab managers are under pressure to have a thorough understanding of their regulated systems as well as increasing laboratory efficiency.
Waters will provide insight on the current focus on data integrity. In addition, we will take look at Waters Empower®3 compliance tools, and overview of NuGenesis® LMS informatics solutions.

Agenda

08:30 Registration and Welcome
09:00 Regulatory guidance's and what's new
The regulators including the US FDA, UK MHRA and WHO have come out with guidance documents on data integrity.
10:00 Informatics Roadmap
New developments on our key Informatics products and related services, including important information on Microsoft Windows support status.
10:30   Coffee Break
11:00 Audit trails and how to use them
  • How should you review the audit trails?
  • How frequently should the audit trails be reviewed?
  • How do you create an evidence that you have reviewed the audit trails?

These and similar questions related to CDS audit trails will be discussed.
11:45 Empower for Data Integrity - Theory and Demo
Configuring Empower 3 for Data Integrity and Regulatory Compliance. A more in-depth introduction into the capabilities of Empower with respect to Compliance and Data Integrity.
13:00 Lunch
14:00 Computer Software validation
Computer software validation is a much-debated topic. 
  • What is CSV?
  • Who and how should this be done?
  • How much of CSV is good enough? 
14:45 Data Archive versus Backup
These two subjects are gaining importance, because of their recent references in the guidance documents published by the regulators.
  • How is data archive different from data backup?
  • Can one replace the other?
  • How do you assure data integrity of archived date? 
15:30 NuGenesis LMS
A detailed overview... What else is possible with NuGenesis LMS. An overview of all the options to work towards a paper-less laboratory.
 16:00 End of Program

We are looking forward to meet you!