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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 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

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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
  FDA 21 CFR Part 11 EU GMP Annex11
Risk management    
Qualification of personnel    
Supplier management    
Validation    
Checks for data entry    
Data back-up    
Data archiving    
Electronic audit trail    
Review of audit trail    
Change control    
Authorized access    
Electronic signatures    
Authorized access    
Incident management    
Business continuity    

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.

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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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:

  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,