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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 352

Risk Based Validation of Computer Systems and Part 11 Compliance

With Strategies for FDA/EU Compliance and Tool Kits for effective implementation

Recorded, available with all reference material at any time

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FDA and other agencies require to "Base software and computer validation and other controls of electronic records on a justified and documented risk assessment". For example the PIC/S Guide on using computers states: "For GxP regulated applications it is essential to carry out a properly documented risk analysis. The inspector will consider the potential risks as identified and documented by the regulated user to assess the fitness for purpose of the particular system(s)"  Risk based compliance  is great because when implemented right it helps to reduce overall validation and compliance costs by focusing resources on high risk systems and save costs on low risk systems. Frequently risk categories are easy to define but the real challenge comes when users should define suitable actions for each category.

Key Questions are:

  • How to define high, medium and low risk systems and electronic records?
  • How to develop a risk based validation program?
  • Are probability and and severity factors enough or do we also need to consider detectability?
  • How to develop and implement a risk based Part 11 compliance program?
  • How to validate high, medium and low risk systems?
  • Do our low risk systems need electronic audit trail function?
  • Should we make a risk assessment for each software requirement?
  • Should we do anything for low risk systems and records?
  • What to test for high/medium and low risk systems and records?
  • How to assess the supplier risk?
  • How can I justify and document my decision for the FDA and for my managers?

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 and examples. After the seminar, an extensive list of reference material like master plans, SOPs, templates and examples will help immediate and cost effective implementation

During the interactive presentation you learn about:

  • FDA/EU and business requirements for risk assessment
  • Guidance from regulatory and industry task forces: ISO, ICH, GHTF, NIST, GAMP/ISPE, PIC/S
  • Practical approaches for risk assessments of computers and electronic records
  • Going through a practical exercise: Relative risk ranking of regulated records
  • Developing a risk based software and computer validation program
  • Developing a risk based Part 11 compliance program
  • Planning and implementing for risk based specifications, vendor assessment, installation, testing, change control, back-up, and contingency planning
  • Risk assessment for network infrastructure
  • Implementing risk based security, audit trail, back-up, archiving and retrieval of electronic records
  • Documenting the decision for management and the FDA
  • Practical examples and specific recommendations from laboratories, office computers and production

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

  • PowerPoint Presentation (helpful to train others)
  • Risk Management Master Plan: 55 pages
  • Risk Management Primer: 71 pages
    Risk Management in the (Bio)Pharmaceutical and Device Industry
  • 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 Computer Systems
  • SOP: 21 CFR Part 11 - Scope and Controls (based on risk assessment)
  • Example: Risk Assessment for a Chromatographic Data System
  • Reference paper: Risk-based Validation of Off-the-shelf Computer Systems
  • Several forms for risk assessment and documentation
  • ICH Q9 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 Presentation, George Smith, How to Take a Risk-Based Approach to Validation in an FDA Regulated Environment
  • Frequently asked questions and answers
  • Script of the presentation
  • More .....

Risk Based Validation of Computer Systems

Vendor Assessment      
OQ Testing      
PQ Testing      
Change Control      
Summary Report      
Back up      

Validation activities should be defined for each risk category. Attend the seminar to learn what is expected for each category

Who should attend?

  • Everybody who is concerned about FDA compliant cost effective software and computer system validation
  • Validation specialists
  • IT specialists
  • QA managers and personnel
  • Software developers
  • Users of software and computer systems
  • Regulatory affairs
  • 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.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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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.-
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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.

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 explained FDA's next 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,