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 136

Validation of Configurable Off-the Shelf Computer Systems (COTS)

Recorded

Typical COTS systems are commercial systems where users can define configuration parameters. Nowadays most computer systems are configurable. When used in regulated environment such systems should be validated. The questions are what should be validated, how and how much.

Specific Questions related to validation of COTS computers are:

• What are the FDA requirements?
• What is specific about COTS systems?
• Which lifecycle model should we use: system development or. system integration
• Should we validate standard functions?
• When should we audit the vendor?
• How to test configuration settings?
• Can we use the vendors specifications or should we develop our own?
• What should we test when the configuration changes and after other updates?

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 regulations and guidelines
• Learnings from recent FDA 483's and warning letters
• Specific requirements for COTS systems
• System development vs. system implementation life cycle
• Developing a validation plan for COTS systems
• Developing specifications for standard functions and configuration settings
• Testing: standard functions and specific configurations
• Change control and revalidation after updates
• Risk based validation of COTS systems
• Validation documentation
• Case studies

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

• Master Plan
  - Computer System Validation (50 pages)
• SOPs:
  - Configuration Management and Version Control of Software
  - Validation of Commercial Off-the-Shelf Computer Systems
  - Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems
  - Risk Based Validation of Software and Computer Systems
  - Change Control of Software and Computer Systems
  - Validation of Electronic Document Management Systems
• Gap analysis/checklists:
  - Using computers in FDA regulated environments
  - Software/Computer system vendor qualification
• Templates/examples
  - Complete Validation example - MD5 software: DQ/IQ/OQ/PQ
  - Testing - Traceability Matrix, Test Protocols, Summary report (29 pages)
  - Computer System Identification
• Warning letters and Inspectional observations related to software and computer validation
• FDA/EU Guidance documents related to software and computer validation

Who should attend?

• IT managers and system administrators
• QA managers and personnel
• Validation specialists
• Regulatory affairs
• Human resources (HR) managers and staff
• All users of computer systems
• Training departments
• Documentation department
• Consultants

How to order

Pick one of the options in the table that fits your needs.

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.	US$ 349.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 349.-
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$ 249.-

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 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.

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.