Auditing Laboratory Data Systems

The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met.
 
FREMONT, Calif. - Dec. 29, 2014 - PRLog -- Description:

The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with laboratory computer systems with an understanding of the controls that are necessary to ensure the integrity of analytical data.

Why Should you Attend:
The webinar will teach participants the importance of correct data system configuration and what to look for during the audit. Businesses will benefit by reducing the risk of regulatory action as a result of failure to comply with current expectations.

Objectives of the Presentation:
The objectives of the presentation are to cover areas such as:
Categories of laboratory data system (GAMP)
Lifecycle management, archiving and backup
What counts as raw data?
Protecting the integrity of analytical data
General guidance on assigning user privileges
Operating system configuration.
Application configuration
Controls appropriate for chromatography data systems
Practices that aid compliance with data integrity requirements
Examples from recent FDA warning letters

Who can Benefit:
Staff who are required to audit analytical operations who do not have a chemical QC background.
Auditors who require updating on current regulatory expectations.
QC staff who needs help in regulatory compliance.
Staff who would like to understand the implications of data integrity for laboratory data systems.

Contact
Online Compliance Panel
***@gmail.com
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Email:***@gmail.com
Tags:Gamp, chemical QC background.
Industry:Biotech, Health
Location:Fremont - California - United States
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