Using the Internet in Regulated Environments

Posted on July 4, 2006 By Corinne Jones News

Using the Internet in Regulated Environments
Requirements and Strategies for Implementation
Thursday, July 27, 2006

Order

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 the e-mails?

• Do I need 3rd party certificates for digital signatures?

• How to ensure limited and authorized access to closed and open systems?

• How can I safely access the company intranet while traveling?

• 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 SOPs, templates and examples will help immediate and cost effective implementation. 

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 the internet

• 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) for remote access

• 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

• SOPs:
  – 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)
• Checklist/Examples
  – Example: Testing Authorized System Access
  – Checklist: Using internet and intranet in regulated environments
• Software and complete validation package: File integrity check with MD5 Hash Calculations, can be used to integrity of e-mail attachments
• 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

• Consultants

About the speaker and guest

Dr. Ludwig Huber is worldwide compliance fellow at Agilent Technologies and author of the Labcompliance Newsletter. He has been conducting web and audio based seminars since five years. He has published several books related to validation and compliance in laboratories, 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. For more information, click here.

Online audio are presented over the phone. During the seminar attendees can: Study the printed slide material Watch the slides on a computer Watch the slides on a video screen in a seminar room

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

Date/time

Date: Thursday, July 27, 2006
US/Canada: 11 a.m. EST, 10 a.m. CST, 8.00 a.m. PST
EU:  5 p.m. CET (Berlin)

How to order/register
CDs can also be ordered after the seminar date

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

by Corinne Jones