Approaches to Improve Regulatory Information Policies and Procedures

Duration: 60 Minutes
Gathering and maintaining records to support submissions to government regulatory organizations for marketing approval and clinical trials support can consume a lot of resources. Since most records are now created electronically, the role of the records room clerk has been largely replaced by specialized software.
Regulatory Information Management
Instructor: Charlie Sodano
Product ID: 500274

This has resulted in automated, more uniform and standardized submissions. However, there has been little improvement in the life cycle management of regulatory records. It still is common practice to retain most if not all related information indefinitely and store it in a collection that is poorly organized.

Why Should you Attend:
Solving document and information management issues by buying specialized software packages will not resolve everything. There is a systematic approach to managing the life cycle of records that should be executed before the purchase and installation of software. This strategy will help in composing RFPs that will help you select the best solutions and compose a records management policy that will improve information management efficiency.

Objectives of the Presentation:
  • Records Management Fundamentals
  • Creating a Records Policy
  • Creating RFPs
  • FDA Records Retention Requirements
Who can Benefit:
  • Research & Development
  • QA
  • QC
  • Regulatory
  • Clinical Operations
  • Manufacturing
  • Records Management
  • Legal
  • Information Technology
  • Validation
$375
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Instructor Profile:
Charlie Sodano began his career as a discovery research chemist at Pfizer. And since1985 has specialized in the management of electronic information as well as paper based records. He managed Information Services departments at RJR Nabisco, Berlex Biosciences and Bayer HealthCare Pharmaceuticals, and holds BS and MS and Ph.D. degrees in Chemistry.

Charlie has more than 20 years experience in the design, improvement and roll-out of Electronic Laboratory Notebooks and electronic records management and archiving systems. He has made numerous presentations at US and international meetings of the American Chemical Society, ARMA International, AIIM, Institute of Food Technologists, EMC Documentum User Meetings and conferences sponsored by leading training and education organizations.

Member of the American Chemical Society and ARMA International. President of ARMA, Mt Diablo Chapter and Regional Coordinator for ARMA International, Pacific Region.
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