Electronic Raw Data in Regulated Environments - Definition, Recording and Archiving - Webinar By GobalCompliancePanel 2011
17 Feb 2011
Webinar
Overview: All regulations have strict requirements for electronic raw data and other e-records.
The objective is to ensure accuracy, integrity, authenticity, security and availability of records during the entire life from generation to deletion. While the intent is the same for all regulations only FDA`s 21 CFR Part 11 and the EU equivalent Annex 11 have well defined requirements but still leave a lot of room for interpretations.
Reference material for easy implementation:
SOP: Recording of GLP and GMP Raw Data.
SOP: Retention and Archiving of Electronic Records
Checklist: FDA Record Retention and Retrieval
Areas Covered in the Session:
FDA Requirements for raw data and meta data
FDA Inspection and enforcement practices
Recommendations from industry task forces: GAMP/ISPE guides
Definition of raw data: original records vs. standard electronic formats, paper print-outs
Ensure and demonstrate integrity of raw data
The importance of risk assessment for the management of raw data
Electronic record maintenance during archiving period
Software to manage and archive raw data and other electronic records
Data migration to new systems
Developing a procedure for consistent raw data management
Examples from laboratories, offices and manufacturing
Who Will Benefit:
IT managers and system administrators
QA managers and personnel
QC and Lab managers
Validation specialists
Regulatory affairs
Training departments
Documentation department
Consultants
Past Events
Electronic Raw Data in Regulated Environments - Definition, Recording and Archiving - Webinar By GobalCompliancePanel 2011 - 17 Feb 2011, Webinar (11651)
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