Labcompliance On-line Audio Seminar

On-line Audio Seminar 147

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)

Risk Based Validation of Software and Computer Systems

- Optimize Your Resources and Comply with FDA Guidelines -

Recorded

Recent FDA and industry guidances recommend to base the extent of validation of software and computer systems. This is great because when implemented right it can help to reduce validation costs. Frequently risk categories are easy to define but the real challenge comes when users should take action to optimize risks versus costs. In this interactive audio seminar we will go through various scenarios and recommend actions for validation and other controls.

Key Questions are:

How to define how, medium and low risk systems
How to develop a risk based validation program
What to validate high, medium and low risk systems? Should we do anything for low risk systems? (Recommendation from FDA's John Murray at the IVT CSV conference: "Avoid the words 'do nothing'. Define and implement controls for each category".)
What to test for high/medium and low risk systems?
How to assess the supplier risk?
How to reduce testing through risk assessment?
How does business risk influence extent of validation?
How can I justify and document my decision?

How does the new interactive 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 and examples. 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/EU and business requirements
Guidance from regulatory and industry task forces: ISO, ICH, GHTF, NIST, GAMP/ISPE
Practical approach for risk assessments
How to develop a risk based software and computer validation program
Validation tasks for risk categories for each life cycle phase
- Planning, design and specifications, vendor assessment, installation, testing, change control, back-up, contingency planning
Validation tasks segmented by system complexity
ocumenting the decision for management and for the FDA
Examples and specific recommendations from laboratories, office computers and production

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

Risk Management Master Plan: 40 pages
SOP: Risk assessment Used for GxP Environments
SOP: Risk-based Validation of Computer Systems
SOP: Risk-based Qualification of Network Infrastructure
SOP: Risk-based Validation of Laboratory Systems
SOP: Risk Assessment for Laboratory Systems
SOP: 21 CFR Part11 - Scope and Controls
Reference paper: Risk-based Validation of Off-the-shelf Computer Systems
ICH Risk Management guide
NIST Guide: Risk Management for IT Systems
Risk Management Guide of the Global Harmonization Task Force (GHFT)
Warning letters and Inspectional observations related to risk assessment.
FDA guidance documents and predicate rules
More ....

Who should attend?

Validation specialists
IT specialists
QA managers and personnel
Software developers
Users of software and computer systems
Regulatory affairs
Training department
Documentation department
Consultants

About Dr. Ludwig Huber

Dr. Ludwig Huber is worldwide director for FDA compliance at Agilent Technologies and author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years.

He 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.

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.

Online audio seminars are presented over the phone. During the live presentation attendees can:

Study the printed slide material
Watch the slides on a computer
Watch the slides on a video screen in a seminar room
Ask questions over the phone
Ask questions through web forms

Attendees can discuss and ask questions over the phone, fax or e-mail.

The transcript and questions and answers have been be posted at the seminar website. This includes questions that came through e-mail and life during the seminar.

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.-