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Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 134

FDA Compliant Electronic Records Management

Requirements, Strategies and Tools for Implementation

Recorded

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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 one hour seminar, the speaker will present strategies and give concise practical recommendations. More than 10 SOPs, templates and examples will help immediate and cost effective implementation.

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
  • 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.

  • - 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

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.