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 213

Requirement Management for Equipment and Computer Systems

Strategies for Development, Documentation and Updating Requirement Specifications

Recorded (Available with all reference material as mp3 download or on CD)

Requirement Specifications (RS) are the most important validation deliverables for equipment, software and computer systems. No or inadequate URS are frequently cited as deviations in FDA inspections. Errors in this early validation phase can have a tremendous impact on overall validation and operation costs. There are no specific guidelines for the development of such documents, so validation professionals are unsure how to proceed.

Frequent questions are

• What are the regulatory requirements
• What is the difference between user requirements, functional and system requirements.
• Can I combine user requirements and functional requirements in a single document?
• How detailed should URS be?
• What should be the level of detail?
• Can I use the manufacturer's specifications?
• How should I document URS, e.g., in which format?
• How to prioritize requirements?
• Who is responsible for development URS?
• What are good and what are bad examples for URS?
• Can we change URS and which process should we follow?
• How to link URS to testing?
• Is there software available to track URS and traceability matrix
• Are there and real life examples for specifications documents

How does the audio seminar help:

Questions will be answered by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar strategies and procedures will be presented on how to develop, document, maintain and update User Requirements. 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:

• Regulatory requirements and industry practices
• Relation of URS with other specifications: e.g., functional specifications, design specifications
• Responsibilities for development
• Procedure for development
• Attributes of URS
• Contents of URS document
• Structure of URS document
• Leveraging manufacturing specifications
• Recommendations from USP <1058>
• Level of detail of specifications
• Organizing and managing the review meeting
• Updating URS
• Good and bad examples

Get 10+ Documents To Do it Right The First Time:
download from special seminar website

• SOPs:
  - Development of Requirement Specifications for Computer Systems
  - Development of Requirement Specifications for Equipment
• Gap analysis/checklists:
  - User Requirement Specifications
  - Using Computers in FDA Regulated Environments
• Templates/examples
  - URS for Chromatographic data systems
  - URS for a Document Management System
  - Requirement Specifications for Electronic Audit Trail
  - URS for Spreadsheet Applications
  - URS for Part 11
  - 20 Good/bad URS Examples and Reasons Why
• Warning letters and Inspectional observations related to specifications
• FDA/EU Guidance documents related to software and computer validation

Who should attend?

• Project owners
• Software developers
• IT managers and system administrators
• QA managers and personnel
• All users of software and computer systems in regulated environments
• Validation professionals
• Training departments
• Documentation department
• Consultants

Date, time and duration

Feb 4, 2008
North America: ET 11 a.m.  CT 10 a.m. PT 8 a.m., Europe: CET 5 p.m (Paris/Berlin)
Check: www.timeanddate.com/worldclock/ for you local time.
The seminar will last one hour

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 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.