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
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On-line Audio Seminar 291

Configuration Management and Change Control for Networks and Computer Systems

Changes of Hardware, Firmware, Software, Networks, Documentation

Recorded, available with all reference material at any time

It is well known that most problems of software, computer systems and networks are introduced when changes are made, either during design and development or during use of the systems. Too many changes of computer systems and inadequate documentation of changes and testing after changes is one of the most frequently cited deviations during FDA inspections. Users of the systems, 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 avoid frequent changes
• 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, security patches
• 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 GAMP IEEE models for configuration management and change control
• How to avoid frequent changes of a computer system
• Reviewing a change control procedure
• Change control for hardware, operating systems and application software
• The change control process for planned and unplanned changes
• Dealing with security patches
• 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 (Baseline Configuration)
  - Identification of network infrastructure and systems
    (Baseline Configuration)
  - Six case studies
• Master plan
  Computer System Validation (53 pages)
• Reference paper:
  Risk based validation of Commercial Off-the-shelf Computer Systems
• FDA 483 inspectional observations and warning letters with deviations related to software, computer systems and change control
• 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

Date, time and duration

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.-
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.-

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.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference Smith and Huber discussed and answered questions about computer system validation and e-records.

	Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference. Mr. Murray explined FDA'snext steps for Part 11
	Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:  Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,