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
Recorded

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
ho 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.
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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.
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US$ 349.-

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Recorded seminar - CD
- Get the CD in your mail
- Order includes all reference material.
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US$ 349.-

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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
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US$ 249.-

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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 author of the Labcompliance Newsletter. He has been
conducting over 100 web and audio or video based seminars since ten years. He is
worldwide director for FDA compliance at Agilent Technologies.
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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 visits FDA in Rockville, VA, and participates
in panel discussions with FDA professionals. For more information,
click here.