Raps Pre-approved Webinar Onensuring Integrity And Security Of Electronic Records For Fda Complia

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

oSOP: Electronic Audit Trail Specification, Implementation, Validation

oSOP: Review of Electronic Audit Trail

oChecklist: Security and Integrity of Electronic Data for Part11/Annex 11 Compliance

Areas covered in the session:

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

oHow FDA inspectors check integrity and security of data

oMost frequent security and integrity issues: going through recent 483's, EIRs and warning letters

oThe importance of limited access to 'individual users' rather than to groups

oFDA compliant definition, acquisition, maintenance and archiving of raw data

oCritical integrity and security issues during the entire life of data: from data acquisition through evaluation to archiving

oExamples how to ensure and document data integrity

oDocumenting changes of data: paper, hybrid systems, electronic

oThe importance of electronic audit trail to document data integrity

oReview of electronic audit trail: who, what, when and how

oEnsuring timely availability through validated back-up and archiving

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

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When:November 27, 10:00 AM PDT | 01:00 PM EDT

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By whom:

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.

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For whom:

This webinar will benefit

oIT Managers and System Administrators

oQA Managers and Personnel

oQC and Lab Managers

oValidation Specialists

oRegulatory Affairs

oTraining Departments

oDocumentation Department

oConsultants

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Duration:75 minutes

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To enroll for this webinar, contact

webinars@globalcompliancepanel.com

Phone: 800-447-9407

ARTICLE LINK

by:GlobalCompliancePanel

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