Approaches to Improve Regulatory Information Policies and Procedures

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Deadline: April 22, 2014 | Date: April 22, 2014

Venue/Country: 38868 Salmon Ter, Fremont, California, U.S.A

Updated: 2014-04-16 18:47:07 (GMT+9)

Call For Papers - CFP

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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