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Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them


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 197

Contingency and Disaster Recovery Planning for Computer Systems

To Ensure Business Continuity and Compliance


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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 on other projects and frequently there is a lack of understanding on how to develop, implement and maintain such plans. 

Key Questions related 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 at other buildings or sites?
  • Who should be responsible for the plans?
  • Developing a plan is easy, but how to implement and maintain the plans?
  • 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, 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

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.


Audio Seminar  Planning for Computer Systems Contingency and Disaster Recovery
: 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