Understanding the recent FDA Guidance on Computerized Systems Used in Clinical Investigations

Instructor: Robert J. Finamore
Product ID: 700842

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Last Recorded Date: Apr-2008

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This webinar will provide valuable assistance to all companies that utilize computerized systems to generate, process, and maintain regulated information as part of a clinical investigation.


This presentation will review the key recommendations from the guidance and will emphasize specific topics that are providing compliance challenges within industry.

In May of 2007, the FDA published a new edition of the guidance on Computerized Systems Used in Clinical Investigations. This document outlines the FDA's current recommendations for ensuring the compliance of systems used for the generation and maintenance of electronic data in clinical investigations. It supplements both the Part 11 regulations and the 2003 Guidance on Scope and Application. Potential solutions for these critical issues will also be discussed.

Areas Covered in the seminar:
  • Differences between the draft and final guidance’s.
  • The key recommendations from FDA.
  • The primary compliance challenges that originate from the guidance
  • Finding potential solutions for identified issues.
  • Necessary procedural controls to support the validation and compliance of clinical systems.
  • Where to find further industry guidance to improve clinical systems compliance.

Who Will Benefit:
This webinar will provide valuable assistance to all companies that utilize computerized systems to generate, process, and maintain regulated information as part of a clinical investigation. The people who will benefit include:
  • End-users responsible ensuring the compliance and validation of clinical systems
  • Study Sponsors
  • Contract Research Organizations(CROs)
  • Data Management Centers
  • Clinical Investigators
  • Institutional Review Boards
  • Vendors who develop computerized systems to be used in clinical investigations

Instructor Profile:
Robert J. Finamore, is a Sr. Validation Manager with CSSC, Inc., a Q Pharma company that provides regulatory compliance consulting services to life science industries. In his 9 years at CSSC, Rob has executed and managed over 100 compliance projects including both large and small scale validation efforts, audits and assessments, global training programs, and quality management system development. Rob is an active speaker on Part 11 and Computer System Validation topics, and has published several articles and white papers in these domains. His most recent whitepaper on Efficient Validation for PDMA Systems is available at CSSC, Inc.

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