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Labcompliance On-line Audio Seminar

On-line Audio Seminar 146

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)

Increasing Productivity With Electronic Laboratory Notebooks

Selection, Implementation and Strategies for Compliance

Recorded

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Electronic Lab Notebooks are rapidly replacing conventional paper note books. They are expected to increase lab efficiency and help to protect IP. The real advantage comes from better sharing data within the laboratory, but also across the enterprise. There are many notebooks on the market with prices ranging from a couple hundred dollars to the 10 or hundred fold. And most of them sooner or later will be used in FDA regulated environments. So industry is unsure what to buy and how to use the in regulated environments.

Key Questions related electronic laboratory notebooks are:

  • What types of note books are on the market?
  • How should we select such notebooks: price, functionality, vendor reputation?
  • How can we get the most productivity gains through ELNs?
  • We have notebooks, but want to use them for FDA work, what should we do?
  • How can we use ELNs to share information across departments and the enterprise?
  • Are there any FDA specific requirements for ELNs
  • How to validate ELNs?
  • Should ELNs comply with Part 11?
  • How can we make existing ELNs compliant?
  • Which laboratory records do we have to keep?
  • For how long should we keep electronic records?

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.

During the interactive presentation you learn about:

  • Benefits of Electronic Lab Notebooks (ELNs)
  • Applications of ELNs in different departments
  • Selection criteria for specific applications or departments
  • Legal requirements for laboratory notebooks
  • FDA requirements for ELNs
  • Requirements for e-record keeping
  • Approach for validation of ELN systems
  • Writing specifications for ELN
  • Installation and testing for initial and on-going use
  • Implementing Part 11 requirements for existing ELNs
  • Preparing an ELN System for an FDA inspection
  • Integrating laboratory notebooks with other systems
  • The ultimate benefit: Sharing information across departments and sites
  • The future of ELN's

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

  • SOPs:
    - Validation of Electronic Laboratory Notebooks
    - Using Electronic Laboratory Notebooks in an FDA Regulated Environment
    - Risk Based Validation of Laboratory Computer Systems
    - 21 CFR Part 11 - Scope and Controls
    - Retention and Archiving of Electronic Records
    - Data Back up and Restore
    - Scanning of Paper Records for GxP Compliant Archiving
  • Templates/Checklist:
    - Gap Analysis/Checklist: Using Electronic Laboratory Notebooks in FDA Regulated Environments
  • Reference Articles
    - Risk based validation of COTS Computer Systems
  • Five Warning letters and/or Inspectional observations related to laboratory computers
  • FDA Reference: Requirements for Laboratory Records

Who should attend?

  • Analysts and lab managers
  • QA managers and personnel
  • IT Managers and staff
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • 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.