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
On-line Audio Seminar 120
Using Internet and Intranet in Regulated
Web applications are increasingly used for all types of businesses, including
healthcare business. Two main applications are the world wide web for all types
of on-line transactions and e-mails for exchanging messages with and without
attachments. The FDA recognizes the expanding role of the Internet and Intranet
in electronic recordkeeping. The Internet cannot be validated but the FDA and
European agencies expect the web to be a trustworthy and reliable communications
pipeline for electronic records. Users of web applications are unsure how to
comply with FDA and EU expectations.
Key Questions related to internet/intranet are:
- Can I use the internet for FDA regulated applications?
- What are FDA's expectations for Part 11 requirements?
- How to validate the internet?
- How to validate web applications?
- How to ensure and verify accuracy of file transfer through
- Do I need 3rd party certificates for digital signatures?
- How to ensure limited and authorized access to closed and
- How can I safely access the company intranet while
- How to best protect my computer from internet attacks?
- How to handle security patches?
- How should I document part 11 compliance for the FDA?
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 a primer,
SOPs, templates and examples will help immediate and cost effective
During the interactive presentation you learn about:
- FDA and international requirements
- Recognize the difference between open vs. closed systems
using case studies
- Learn how e-mails are created, transferred and read
- How to ensure integrity, authenticity and non-repudiation of
- Understand the concept of digital signatures, digital
certificates and public key infrastructure (PKI)
- Sending cryptography secured e-mails and attachments
- Set up and use a virtual private network (VPN)
- Expectations for internet security
- Handling security patches
- Validating web based applications
- Developing procedures on using internet/intranet
- Documentation required by the FDA
And for easy and instant implementation:
download 10+ documents from special seminar website
- Using the Internet in Regulated Environments
- Handling Security Patches
- Verification of File Accuracy Sent by E-mail
- Validation of Web Based Applications
- Validation of Commercial Off-the-shelf Systems
- Change Control of Networks (planned changes))
- Change control of networks (unplanned changes)
- Example: Testing Authorized System Access
- Checklist: Using internet and intranet in regulated
- Software and complete validation package: File integrity
check with MD5 Hash Calculations, can be used to integrity of
- 23 page primer on Using Internet and Intranet in Regulated
Environments. An excellent training tool for beginners.
- NIST NIST Special Publications:
- Guidelines on Electronic Mail Security
- Procedures for Handling Security Patches
- Guidelines on Firewalls and Firewall Policy
- Other publications..
Who should attend?
- QA managers and personnel
- All users of internet, intranet and e-mails
- IT professionals
- Validation specialists
- Regulatory affairs
- Training departments
- Documentation department
How to order
Pick one of the options in the table that fits your needs.
Replaced by the more recent seminar
Using the Internet and Intranet in
Requirements and Tools for E-Mails,
Web-Applications and Corporate Networks
About audio seminars
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 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
||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,