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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 138

Change Control for Computer Systems

Hardware, Firmware, Software, Networks, Documentation

Recorded

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It is well known that most problems of software, computer systems and networks are introduced when changes are made, either during development or during use of the systems. Inadequate documentation of changes and testing after changes is one of the most frequently cited deviations during FDA inspections. Users of the system, system owners and network administrators are unsure on how to document initial set-up and manage changes.

Key Questions for change control are:

  • What is the difference between configuration management and change control
  • How to document the configuration baseline
  • How detailed should networks be documented - e.g., cables
  • How to initiate and authorize changes
  • What and how much to test after the change
  • How to develop SOPs and forms for change requests, release and tracking
  • How to manage unplanned changes, e.g., hot fixes
  • How to deal with service packs and patches
  • How to deal with changes made by vendors and 3rd parties
  • How to deal with changing user requirements during software development?
  • The FDA recommends regression testing after software changes - what does this mean in practice

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. Attendees will learn how to avoid problems through application of proven industry practices for configuration management and change control.

During the interactive presentation you learn about:

  • US FDA and EU requirements for change control
  • Defining configuration management vs. change control and change management
  • The IEEE model for configuration management and change control
  • Reviewing a change control procedure
  • Change control for hardware, operating systems and application software
  • The change control process for planned and unplanned changes
  • Versioning of software and computer systems
  • What to test after changes
  • How to document changes
  • Going through examples
    - hardware
    - firmware
    - software (operating system, applications, security patches)
    - networks (server, client, router)
    - documentation (specifications)

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOPs:
    - Change control of software and computer systems
    - Change control of networks - planned changes
    - Change control of networks - unplanned changes
    - Handling security patches
    - Configuration management and version control of software
  • Templates/Examples
    - Identification of computer systems
    - Identification of network infrastructure and systems
  • Reference paper:
    Risk based validation of Commercial Off-the-shelf Computer Systems
  • FDA 483 inspectional observations and warning letters with deviations related to software and computers
  • FDA regulations and guidelines related to computer validation
  • And more....

Additional benefit: Receive six case studies

Case studies include typical planned and unplanned changes from production control, laboratory controls and documentation. They include planned and unplanned changes of specifications, hardware, firmware, operating software, application software and MS security patches.

Who should attend?

  • Validation specialists
  • QA managers and personnel
  • Regulatory affairs
    IT department
  • Training department
  • Documentation department
  • Consultants

How to order

Replaced by the more recent seminar

Configuration Management and Change Control for Computer Systems

Changes of Hardware, Firmware, Software, Networks, Documentation

Click here

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.