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

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

About Dr. Ludwig Huber

Dr. Ludwig Huber is worldwide director for FDA compliance at Agilent Technologies and author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years.

He 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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.

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.

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

Study the printed slide material
Watch the slides on a computer
Watch the slides on a video screen in a seminar room
Ask questions over the phone
Ask questions through web forms

Attendees can discuss and ask questions over the phone, fax or e-mail.

The transcript and questions and answers have been be posted at the seminar website. This includes questions that came through e-mail and life during the seminar.

How to order

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

Recorded seminar - Web download 'Site' offer

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$ 349.-

Recorded seminar - CD

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