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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 199

Understanding and Implementing the New EU Annex 11

Learn about specific requirements and get tools for implementation


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After more than 15 years the EU has released a new version of Annex 11: the European equivalent of FDA's Part 11. Compared to the older version it has more detailed and has some very specific requirements. It addresses the regulatory needs of modern IT equipment and when implemented right, also has business benefits through reduced failure rates. The document is a good framework for validation and using computer systems in different regulated environments. On the other hand it leaves a lot of room for interpretation and therefore the aim is not to teach how to implement systems.

Key Questions related to the contents of the new Annex are:

  • What is the status of this Annex: guidance or regulation?
  • Are there any specific or 'new' requirements?
  • How does it compare with GAMP5 ®
  • Does it require a specific lifecycle model?
  • How does it compare with FDA's new interpretation for Part 11?
  • The Annex requires to base decisions on  justified risk assessment. How should this be done?
  • What does 'suitable checks' of spreadsheets mean?
  • What should be included in the system inventory?
  • What are 'suitable methods' of preventing unauthorized system entry?
  • How to design data systems for data integrity?
  • What does an 'appropriate qualification ' of suppliers mean?
  • Do we have to keep electronic raw data in addition to paper printouts?
  • When can inspectors ask for system access to study e-records

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:

  • History and status of the Annex
  • Relation to other documents: GAMP5 ®, Part 11,  Annex 15
  • Justification and documentation of risk assessment
  • Validation requirements. level of detail
  • Testing specific configurations: spreadsheets, data bases, data systems
  • Required validation documents
  • Management of electronic records: acquisition, evaluation, archiving
  • Adequate handling electronic signatures
  • Business continuity planning
  • Adequate accuracy checks for manual and automated systems
  • The role of the Qualified Person for automated systems
  • Recommendations for implementation

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

  • Computer System Validation Master Plan (30+ pages)
  • Five example SOPs:
    - Risk Based Validation of Computer Systems
    - Validation of Commercial Off-the-shelf Computer Systems
    - Quality assessment of Software and Computer System Suppliers
    - Validation of Spreadsheet Applications
    - Data Back-up and Restore
    - Change Control of Software and Computer Systems
    - Auditing Computer Systems
    - Training for Computer Validation
    - Access Control to Computer Systems and Data
  • Gap analysis/checklist:
    - Annex 11 Version 2008
  • Validation Examples
    - Identification of Network Infrastructure and Systems
    - Test Plan and protocol: 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
  • QA managers and personnel
  • Site and operations managers
  • Users of regulated computer systems and records
  • Software Developers
  • Validation specialists
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants

How to order

Replaced by the more recent seminar

Understanding and Implementing the New EU Annex 11

Learn about specific requirements and get tools for 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.