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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.

On-line Audio Seminar 109

Risk Based Computer Validation and Part 11 Compliance


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Recent FDA and industry guidances recommend to base the extent of validation of computer systems and other controls on risk assessment and system complexity. 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 develop a risk based validation program
  • What to validate for 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".
  • How does system complexity influence extent of validation?
  • How does the risk impact part 11 controls such as audit trails, archiving and back-up?
  • ow 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
  • 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
  • Part 11 controls for all risk categories (high, medium, low)
    - audit trail, archiving, e-copies, validation -
  • How to document my decision for my 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

  • SOPs:
    - Risk based computer validation
    - Define scope and controls for GxP and part 11
    - Risk Assessment for GxP and part 11 compliance
  • Work sheets: Validation tasks for risk categories
  • Guidances
    - US FDA regulations/Guidances related to computer/SW validation
    - EU regulations/Guidances related to computer/SW validation
  • All US FDA predicate rules
  • More...

Who should attend?

  • Validation specialists
  • IT specialists
  • QA managers and personnel
  • Regulatory affairs
  • Training department
  • Documentation department
  • Consultants

How to order

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

Replaced by the more recent seminar

Risk Based Computer Validation and Part 11 Compliance

With Strategies for FDA/EU Compliance and Practical Tools for Effective implementation

Click here

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.