subject: Raps Pre-approved Webinar Onensuring Integrity And Security Of Electronic Records For Fda Complia [print this page] Description: Description:
Lack of data integrity has posed a serious concern for regulatory authorities. The FDA has detected and reported hordes of cases where companies have manipulated electronic records to show Out-of-Specification (OOS) results as specifications. This has made FDA inspectors concentrate on critical parameters such as security, availability, accuracy and integrity of 'complete' records during GLP, GCP and GMP inspections.
This webinar will give participants an understanding of how to effectively bring about integrity and security into their electronic records. This session will be useful to those in the industry who are unsure about how to implement these elements into their records. As result of this learning, they will be able to successfully pass an FDA inspection instead of inviting 483s and Warning Letters as most others do.
It will provide tools and recommendations for effective implementation of electronic records that have integrity and stability and comply with FDA requirements. It offers these materials to help bring about easy implementation:
oSOP: SOP: Integrity and Security of Electronic Records
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. Ludwig is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of many books, including Validation and Qualification in Analytical Laboratories and Validation of Computerized Analytical and Networked Systems.
He also has more than 100 literature publications and conducts online tutorials regularly. His works speak of his erudition and deep understanding of everything that goes into FDA compliance. That Dr. Huber is a renowned expert on not only the FDA but also other regulatory bodies is evident from the fact that he has been Chief Advisor on Global ISO 17025 and FDA Compliance.
