74 2014 - Approaches to Improve Regulatory Information Policies and Procedures

Instructor: Charlie Sodano
Description:
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.
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
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