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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 157

Preventing and Handling Security Incidents

Ensuring SOX and FDA Compliance and Protecting Your Company’s Assets

Paul Drapeau

IT Security Vertex Pharmaceuticals


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The information security landscape changes at a very rapid pace. New threats and vulnerabilities are discovered on a daily basis. Federal laws and regulations such as the Sarbanes-Oxley Act and FDA's CFR Part 11 expect companies to implement controls to ensure security of systems and data. Technology choices in the network and system security space are vast and difficult to evaluate and deploy effectively. Even the best security infrastructures and environments are subject to compromise from determined attackers or unanticipated methods of attack.

The costs of information security incidents can be great in terms of money spent, down time, and compliance risk. Security incidents represent a direct impact to the validated state of computer systems

Some questions remain:

  • What does the current information security threat landscape
  • What can we learn from recent attack trends?
  • What are the common results of a security incident and how does a compromise affect the validated state of a computer system?
  • What are the regulatory implications of a network compromise?
  • How do technology and policy relate to protecting IT environments from these threats?
  • How should an organization prepare to handle an information security incident?
  • What audit trails are important in a security incident and how can their integrity be protected?
  • How does good Identity Management help in the event of a security incident?
  • How do factors like company size, industry or budget play into an information security strategy?

How does the audio seminar help:

The presenter will discuss

  • The current state of information security attacks
  • Compromises and trends based on concrete data and
  • Real world examples.

Information will be presented that will help you to assess the risks to your data, compliance status, and information systems presented by different types of attacks or compromises. You will learn how to use information about known threats and new vulnerabilities to evaluate and protect your environment.


A basic framework for handling security incidents will be presented that can apply to any organization regardless of size or staffing levels

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

  • Sample security policy statements that will help you to integrate security incident handling into an existing policy framework
  • A sample operational document that will describe the procedure for responding to security incidents
  • Checklist for constructing effective security incident response frameworks in your organization
  • SOP: Handling Security Patches
  • SOP: Change Control for Unplanned Changes
  • SOP: Change Control of Software and Computer System
  • NIST Guide: Procedures for Handling Security Patches
  • NIST Guide: Electronic Mail Security
  • NIST: Guide: Firewalls and Firewall Policy
  • Links to Top 20 security vulnerabilities and security incidents reports
  • Regulations and guidelines
  • FDA warning letters related to the topic

Who should attend?

  • Information Systems Executive Management
  • Information Technology Management
  • Network Managers and Staff
  • System or Application Administrators
  • Information Systems Validation Professionals
  • Internal QA Managers and Staff
  • Training Staff

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.