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
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On-line Audio Seminar 271
Periodic Review and Evaluation of Computer Systems
With strategies and tools for FDA and EU
compliance
Recorded, available with all reference material
at any time

Periodic Evaluation and Review of critical computer systems assures that the
system is operating within its validated state. The FDA expects a periodic
evaluation and periodic evaluation of computer systems became a legal
requirement for the European market after July 1, 2011. Chapter 11 of the new EU
GMP Annex 11. However, companies are unsure how to conduct and document periodic
reviews.
Key Questions related to Evaluation and Periodic Reviews of Computer
Systems are:
- There are FDA waning letters about missing periodic review,
what is the legal basis for this?
- What are exact FDA and international requirements?
- What are the benefits of periodic evaluation and review?
- Why should we do reviews, we have validated our system and
follow procedures for changes?
- Does periodic review substitute regular revalidation?
- What is the recommended frequency reviews: 3, 6, 12, 24
months, or more?
- What events trigger periodic review, change control, system
failures, others?
- Where to get inputs for periodic inputs?
- Who is responsible for regular evaluation and periodic
review?
- What is the difference between gap analysis and periodic
review?
- What should we look at for evaluation and reviews?
How does the 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:
- FDA and international regulations and guidelines
- Inspection and enforcement practices
- Purpose and objectives of the evaluation and review
- The role of periodic evaluation and review vs. internal
audits and gap analysis
- Developing an SOP for evaluation and review
- Responsibilities, tasks and owners
- Frequency and timing of evaluations and reviews
- Criteria and justification for frequency or review vs.
revalidation
- Inputs for reviews
- The review process from planning to documentation
- Corrective and preventive action plans
- Documentation for the FDA and other agencies
And for easy and instant implementation:
download 10+ documents from special seminar website
- PowerPoint Presentation
- Script
- SOPs
- Periodic Review and Evaluation of Computerized Systems
- Change Control of Software and Computer Systems
- Configuration Management and Version Control
of Software.
- Checklist: Periodic Evaluation and Review of Computerized
Systems
- Forms and blanks
- Documenting Deviations of Computer System Reviews
- Documenting Corrective Actions of Computer System Reviews
- Warning letters and/or Inspectional observations related to
computer system validation
- Others
Who should attend?
Industry
- Pharmaceutical development and
manufacturing
- Biopharmaceutical development and
manufacturing
- Medical device
- Blood testing/Clinical testing
Functions
- IT managers and system administrators
- QA managers and personnel
- QC and Lab managers
- Validation specialists
- Regulatory affairs
- Human resources (HR) managers and staff
- Training departments
- Documentation department
- Consultants
Date and time
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.-

|
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.-

|
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.
Dr. 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 explined FDA'snext 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, |