Page 1

Toll Free Number: 800-447-9407

RAPS Approved Webinar on

Ensuring Integrity and Security of Electronic Records for FDA Compliance Date: Wednesday, November 28, 2012

Time: 10:00 AM PST | 01:00 PM EST

Course "Ensuring Integrity and Security of Electronic Duration: Records for FDA Compliance" has been pre-approved Instructor: by RAPS as eligible for up to 1.25 credits towards a participant's RAC recertification upon full completion. Location: Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies

75 Minutes Dr. Ludwig Huber Online

Register Now

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. ...more

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.

Areas Covered in the Session: l

Eight key FDA/EU requirements for integrity and security of electronic data

l

How FDA inspectors check integrity and security of data Most frequent security and integrity issues: going through recent 483's, EIRs and warning letters?

l

l

l

l

l

l

l

l

l

l

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 backup and archiving Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions

Who Will Benefit: l

IT Managers and System

l

Administrators QA Managers and Personnel

l l

More Webinars

QC and Lab Managers Regulatory Affairs

l

Training Departments Documentation Department

l

Consultants

l

Suggest a Topic

Click here to register for this webinar


It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com

1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Ensuring Integrity and Security of Electronic Records for FDA Compliance  

Overview: FDA has found and reported about multiple cases where companies manipulated electronic records to bring out-of-specification resul...

Read more
Read more
Similar to
Popular now
Just for you