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 202

Cost Effective Software and Computer System Validation

Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5

Recorded

Software and computer systems are getting more and more complex. Systems offer more functions than ever at lower costs. However, increasing number of used functions also means more validation effort. As a consequence frequently validation costs surpass costs for computer hardware and software. Both industry task forces such as GAMP®, standard committees such as USP and ASTM, and regulatory agencies such as the FDA  and EMEA recognize this and promote new cost effective ways for validation. However the industry in unsure how the new guidelines can be implemented in the most cost effective way.

Key questions related to cost savings for computer validation are :

• What are the key points of GAMP®5 and Annex 11 for cost savings?
• What  is FDA's approach?
• What does ASTM 2500 recommend?
• Which systems don't need to be validated at all?
• How can I save cost during testing:?
• How can software suppliers help to save validation costs?
• Can automated test tools really reduce costs or do I also have to validate them?
•  I have five identical systems, do I have to validate them all?
• My vendor provides validation certificates, do I have to do anything in addition?
• How much documentation do I need?
• Do we need signatures on each validation sheet?
• How does risk based validation help?
• Is this all useful for clinical studies?

How does the this 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:

• Problems with the traditional inefficient way of computer system validation
• Savings from recent new FDA, EMEA, ASTM 2500, USP 1058 and GAMP® 5 documents
• Savings through risk based validation
• Leveraging vendor validation, documentation and services
• Savings through scalable validation
• Savings through standardization from design, and development to testing and documentation
• Avoiding to duplicate efforts
• Leveraging multiple installations
• Leveraging validation at other sites
• Efficient use of forms and templates with examples

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

• Computer System Validation Master Plan (30+ pages)
   with most recent updates for cost savings
• Two example SOPs:
  - Risk Based Validation of Computer Systems
  - Validation of Commercial Off-the-shelf Computer Systems
• Template/Gaps analysis/checklist:
  - Eight proven templates for cost effective documentation
  - Checklist: Cost Effective Software and Computer System Validation
• Forms
  - Cost Control of Computer System Validation
  - Identification of projects with highest potential for cost savings 
• Validation Examples
  - Examples for validation of an electronic document management system
• Reference Publication
  - Risk based Validation of COTS computer Systems
• FDA and EU regulations and guidelines related to computer systems

Who should attend?

• IT managers and staff
• Financial controllers
• QA managers and personnel
• Site and operations managers
• Software Developers
• Validation specialists
• Regulatory affairs
• 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$ 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.