Ensuring Integrity and Security of Laboratory Data

Aug. 24, 2011 - PRLog -- Why to attend:
   
Because of severe manipulations of computerized laboratory data by industry FDA inspectors focus on integrity and security of electronic records. This seminar will provide all information on how to demonstrate integrity and security of laboratory data. Attendees will also receive strategies and tool kits such as SOPs, examples and Case Studies for easy implementation.  

Contents:
*  Eight key FDA/EU requirements for integrity and security of laboratory 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
* Examples how to ensure and document data integrity
* Documenting changes of laboratory 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
* Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions


Date:  September 8,2011

Who should attend
* Laboratory managers and staff
* Analysts
* QA managers and personnel
* Quality control unit staff
* Regulatory affairs
* Training departments
* Documentation department

Weblink:  http://www.labcompliance.com/seminars/audio/274/default.aspx

Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, laboratory, FDA, validation