Labcompliance On-line Audio Seminar
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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
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On-line Audio Seminar 350
Understanding and Implementing the New
EU-PIC/S Annex 11
Learn all about similarity and difference
to Part 11
Recorded, available with all reference material
at any time

Testimonials
We have received very positive feedback from
attendees of previous seminars. To
learn how the seminar helped to understand and implement
Annex 11,
click here
Introduction
After more than 15 years the EU has released a new final version of Annex 11. It
has been in effect as a regulation since July 2011 but only recently EMA started
to enforce the Annex. Together with the updated EU Chapter 4 on documentation it
is the EU equivalent to FDA's Part 11. It also 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 use of computer systems and handling electronic records in different
regulated environments. And since Annex 11 has been adopted by PIC/S it will
have a very high impact on more than 40 countries, including USA and Canada, all
EU members and all ASEAN member countries. On the other hand the Annex
leaves a lot of room for interpretation that raises lots of questions.
Key Questions related to the contents of the new Annex are:
- What is the status of this Annex: guidance or regulation?
- What are the or 'new' requirements?
- Are there new roles and responsibilities to be defined?
- Does validation 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?
- Is electronic audit trail always required?
- How to design data systems for data integrity?
- What are the recommendations of the updated documentation
chapter 4 related to electronic raw data and hybrid systems,
e.g., do we have to keep electronic raw data in addition to
paper printouts?
- Are e-signatures mentioned and what are the requirements?
- What does it mean: it has been adopted by PIC/S
- What is similarity/difference to GAMP 5
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, status and future of the Annex
11
- Relation to other documents: GAMP5 ®, Part 11, Annex 15,
PIC/S Good Practice Guide on Using Computers
- New expanded scope of Annex 11
- Justification and documentation of risk
assessment
- The responsibility of the process owner and system owner
- Supplier management through formal agreements
- Requirements for validation throughout the lifecycle
- Considerations about using automated test tools
- Management of electronic records from acquisition to
archiving to ensure data integrity
- Definition of raw data
- Adequate handling electronic signatures
- Requirements for back-up, incident management and business
continuity
- 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
- PowerPoint Presentation
- Script
- Computer System Validation Master Plan (30+ pages)
- Ten 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
- Disaster recovery of Computer Systems
- Auditing Computer Systems
- Training for Computer Validation
- Access Control to Computer Systems and Data
- Gap analysis/checklist/worksheet:
- Annex 11 Version 2011
- Validation Examples
- Identification of Network Infrastructure and Systems
- Test Plan and protocol: Electronic Document Management System
- Requirement Specifications for Electronic Signatures
- Reference Publication
- Risk based Validation of COTS computer Systems
- FDA and EU regulations and guidelines related to computer
systems
- EU GMP Annex 11 EU GMP Chapter 4 on Documentation
Who should attend?
- IT managers and staff
- QA managers and personnel
- Qualified persons
- Site and operations managers
- Users of regulated computer systems and records
- Software Developers
- Validation specialists
- Regulatory affairs
- Training departments
- Documentation department
- Consultants
Risk management |
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Qualification of personnel |
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Supplier management |
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Validation |
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Checks for data entry |
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Data back-up |
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Data archiving |
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Electronic audit trail |
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Review of audit trail |
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Change control |
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Authorized access |
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Electronic signatures |
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Authorized access |
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Incident management |
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Business continuity |
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Annex 11 addresses all computer and data
management requirements, including validation.
Most of them are also required by Part 11 and the related guidance
document, but also through FDA inspection and enforcement practices.
The seminar will go through requirements and give recommendations on
how to implement them from the view of FDA and European inspectors.
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.
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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
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US$ 299.-

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Testimonials/References
The Feedbacks on the seminar has been
received by e-mails. Labcompliance has permission to use the
testimonials as references. Original e-mails are stored in the
Labcompliance archive.
- Amy Gilooly,
Synta Pharmaceuticals Corp,
Assoc. Director, Quality Systems Department, USA
The seminar did exceed my
expectations
It successfully provided
an over-view of the new Annex 11 regulatory requirements and
differences from and similarities to 21 CFR Part 11 It
also provided a concise and useable reference guide to the scope
and intent of the new EU Annex 11.. (Ref
1165)
- Joachim Fehr,
Stryker Leibinger GmbH & Co. KG, CSV Specialist,
DPO/CSV. QA
Germany
The seminar did exceed my
expectations
Very good seminar with very
clear description of the requirements. Good practical
examples. Good references. Recommendation to
attend. (Ref 1091)
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.
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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
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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. |
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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
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Ludwig Huber
(right) in a panel discussion with FDA inspectors and
directors:
Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare, and
Nicholas Buhay, |