Ensuring Integrity and Security of Electronic Records for FDA Compliance

April 12, 2012 - PRLog -- This seminar will discuss how to comply with FDA's ongoing Part 11 inspection program  

Why to attend:
   
FDA has found and reported about multiple cases where companies manipulated electronic records.  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 50 warning letters and 483 form inspectional observations related to electronic records. Attendees of this seminar will learn how to comply with FDA Part 11 inspection requirements.        

Areas Covered in the Seminar:

*  Eight FDA/EU requirements for integrity and security of electronic records
*  How FDA inspectors check integrity and security of data
*  Most frequent security and integrity issues
*  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
*  Examples how to ensure and document data integrity
*  Documenting changes of regulated 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 10 representative case studies
                   
Date:  May 8,2012
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide

Who should attend
* All companies generating electronic records in regulated environments
* Pharmaceutical and Device Manufacturers
* API Manufacturers
* Documentation professionals
* QA/QC managers and personnel
* Analysts and lab managers
* Validation specialists
* Regulatory affairs
* Consultants



Weblink:  http://www.labcompliance.com/seminars/audio/290/default.aspx

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, Device Manufacturer, FDA, Records