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
Recorded

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
|
About audio seminars

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 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.