Ensuring Integrity and Security of Electronic Records for FDA Compliance - Webinar By GlobalCompliancePanel November 27, 2012

Overview: FDA has found and reported about multiple cases where companies manipulated electronic records to bring out-of-specification results into specifications. Since then FDA inspectors have focused during GLP, GCP and GMP inspections on security, availability, accuracy and integrity of 'complete' records.

FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors. Just in the last three years FDA issued over 30 warning letters and 483 form inspectional observations related to electronic records. The industry is unsure how to comply with FDA inspection requirements. This seminar will give a good understanding of FDA requirements and provide recommendations and tools for effective implementation.

Reference material for easy implementation:
SOP: SOP: Integrity and Security of Electronic Records
SOP: Electronic Audit Trail - Specification, Implementation, Validation
SOP: Review of Electronic Audit Trail
Checklist: Security and Integrity of Electronic Data for Part11/Annex 11 Compliance

Areas Covered in the Session:
Eight key FDA/EU requirements for integrity and security of electronic data
How FDA inspectors check integrity and security of data
Most frequent security and integrity issues: going through recent 483's, EIRs and warning letters?
The importance of limited access to 'individual users' rather than to groups
FDA compliant definition, acquisition, maintenance and archiving of raw data
Critical integrity and security issues during the entire life of data: from data acquisition through evaluation to archiving
Examples how to ensure and document data integrity
Documenting changes of data: paper, hybrid systems, electronic
The importance of electronic audit trail to document data integrity
Review of electronic audit trail: who, what, when and how
Ensuring timely availability through validated back-up and archiving
Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions

Who Will Benefit:
IT Managers and System Administrators
QA Managers and Personnel
QC and Lab Managers
Regulatory Affairs
Training Departments
Documentation Department
Consultants

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

Webinar By GlobalCompliancePanel

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

[email protected]
http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Event Link - http://bit.ly/O9AgNP