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
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On-line Audio Seminar 385
Contingency and Disaster Recovery Planning
for Computer Systems
To Ensure Business Continuity and
Compliance
Recorded, available with all reference material
at any time

Processes that rely on computer systems and network infrastructure should
continue whenever the computer system or network fails. And once the system
fails it should be brought back into working conditions as quickly as possible
and lost data should be recovered. All this requires both a good contingency
planning as well as disaster recovery planning process. Many companies don't
have such plans because resources are working on other projects and frequently
there is a lack of understanding on how to develop, implement and maintain such
plans.
Key Questions related to contingency and disaster recovery planning
- What regulations require contingency and disaster recovery
planning?
- What are FDA requirements for back-up: back-up type,
frequency, offsite, media?
- What is the difference between business continuity,
contingency, and disaster recover planning
- We perform regular back-up of our data; is this enough?
- How much should we invest in contingency and recovery
planning?
- How to control external vulnerabilities?
- Do we need to back-up our archived data at other buildings
or sites?
- Who should be responsible for the plans?
- Developing a plan is easy, but how to implement and maintain
the plan?
- How to validate recovery plans?
- Can we outsource disaster recovery?
- How does contingency&recovery planning relate to risk
management processes?
- How much resources should we plan: money, personnel?
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: FDA, EMA, PIC/S, SOX,
ISO
- Definitions: business continuity, disaster recovery,
contingency planning
- The objectives of contingency and disaster recovery plans
- Developing an overall strategy for business continuity
- Linking contingency and disaster recovery planning to risk
management
- Identification of vulnerabilities and associated risks:
internal and external?
- Work flow analysis as prerequisite for cost effective
rational planning
- Seven step integrated contingency/disaster recovery process
- FDA compliant back-ups: type, frequency, offsite, location,
media
- Communication of the plan and training
- Developing recovery strategies
- Validation of contingency and recovery plans
- Maintaining and improving the plan
And for easy and instant implementation:
download 10+ documents from special seminar website
- SOPs
- Disaster Recovery of Computer Systems
- Contingency Planning for Computer Systems
- Change Control of Networks: Unplanned Changes
- Data Backup and Restore
- Checklist:
- Business continuity and disaster recovery for computer systems
- Template/Examples
- Disaster recovery plan
- Steps for Recovering from a UNIX or NT System Compromise
(Link)
- Forms
- Computer System Incident Report Form
- Data Back-up Documentation
- Data Restore Documentation
- NIST guide
- Contingency Planning Guide for IT systems
- NFPA 1600: Standard on Disaster/Emergency Management and
Business Continuity Programs
Who should attend?
- Individuals responsible for computer systems and data
- Individuals responsible for contingency and disaster
recovery planning
- IT managers and personnel
- Emergency response managers
- Everybody responsible for FDA compliance of computer systems
- Managers from purchasing, documentation and operations
- All users of computer systems used in regulated environments
- QA managers and personnel
- GLP/GMP/GCP auditors
- Consultants
- Teachers
Date and
time
Recorded seminar, available at any time with all
reference material
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.-

|
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:
- 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
agencies.
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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 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.
Testimonial
Audio Seminar
Planning for Computer Systems Contingency and Disaster
Recovery
Feedback:
Mr Huber seemed to me very well versed on the subject. I was
grateful for the detail in the presentation. I enjoyed also that he
broke down who or what departments may take responsibility for
various processes of the plan responsibilities. Looking forward to
the next seminar
Brian Howell, Teva Pharmaceuticals, Quality Technical Services
Department, USA