On-Line Audio Seminar – FDA Compliant Electronic Records

Posted on October 31, 2005 By Corinne Jones News

Newsletter Special

LabCompliance-News
Newsletter Special 17-05

Information Service from Labcompliance, the global on-line resource for compliance and validation

 

FDA Compliant Electronic Records Management

Electronic records are more and more replacing paper records to demonstrate compliance with regulations. Advantages are more convenient search capabilities, easier communication across different sites and last but not least smaller storage volumes. While FDA regulated companies are quite familiar with compliance of paper records, there are many questions related to electronic records, especially when using more recent communication technologies, such as e-mails.. 

Key Questions related to electronic records management are:

  • What are current and future US FDA requirements for electronic records?

  • Are there different requirements in Europe or Asia?

  • What are inspectors looking for?

  • How to archive electronic formats: standard files or proprietary formats?

  • How to define raw data  and meta data?

  • What should be contents of a retention policy?

  • We scan paper documents for easier search, can we destroy the paper?

  • We  transcribe paper records into a computer, do we need to keep the paper?

  • We plan to purchase an electronic records management system, what should we care about?

  • What should we care about when we migrate to a new computer system

  • We want to use e-mails to communicate regulated activities, what should we care about?

  • What should I care about when I sign electronic documents?

How does the audio seminar help:

Answers will be presented  by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

On-line Audio Seminar
FDA Compliant Electronic Records Management
Requirements, Strategies and Tools for Implementation

on Thursday, November 3, 2005
with Dr. Ludwig Huber as presenter
 

During the interactive presentation you learn about:

  • FDA requirements for electronic records
  • International requirements: Europe, Japan
  • Industry recommendations: GAMP, ISO 15489
  • Type of records to be maintained and archived
  • The lifecycle of electronic records
  • Options to sign electronic documents
  • Converting paper into electronic records:
  • Developing a strategy and procedures for electronic records
  • Using e-mails for regulated activities
  • Best practices for long term archival and retrieval
  • Ensure and demonstrate integrity of electronic records
  • Electronic record maintenance during archiving period
  • Considerations for Electronic Document Management Systems
  • Migration of records to new systems
  • Record maintenance during archiving
  • Case studies

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOP: Retention and Archiving of Electronic Records
  • SOP: Validation of Electronic Document Management Systems
  • SOP: Scanning of Paper Records for GxP Compliant Archiving
  • SOP: Retirement of Computer Systems
  • SOP: Data back-up and Restore
  • SOP: Validation of Commercial Off-the-Shelf System
  • Checklist: Using computers in FDA regulated environments
  • Regulatory reference documents:
    – FDA Drug cGMP:  Requirements for Laboratory Records
    – FDA Drug cGMP:  Requirements for Manufacturing Records
  • Literature Reference papers. I
    – Implementing 21 CFR Part 11 – Data Migration and Long Term Archiving for Ready Retrieval
    – Risk-based Validation of Commercial Off-the-Shelf Computer Systems
  • Warning letters and Inspectional observations related to electronic records.
  • FDA guidance documents and predicate rules

Who should attend

  • Record managers

  • Documentation professionals

  • Archivists

  • QA managers and personnel 

  • Analysts and lab managers

  • Validation specialists

  • Regulatory affairs

  • Human resources (HR) managers and staff

  • Training departments

  • Consultants

To get more information on content and registration, visit

http://www.labcompliance.com/seminars/audio134

Share the Labcompliance Newsletter with a friend

Feel free to forward this newsletter to your colleagues. They can get free subscription through http://www.labcompliance.com/newsletter.htm

If you are not interested to receive this newsletter any more, send an e-mail to info@labcompliance.com, Re: sign off  newsletter

This e-newsletter may contain links to sites on the Internet that are owned and operated by third parties. Labcompliance is not responsible for the content of any such third-party site.

Copyright ©  Labcompliance,  All rights reserved
Last Updated: 24-10-2005
By accessing this site users (visitors) agree to the
Labcompliance terms of use (disclaimer)

<!– document.write('‘) // –>

by Corinne Jones

Website

Related Posts