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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Online Audio Seminar 300
Cost Effective Validation of Laboratory
Computer Systems
With industry proven examples for all
validation steps
Recorded, available with all reference material
at any time
Laboratory systems are amongst key targets of FDA inspections. They are
considered high risk systems because they can have a high impact on the quality
of APIs and drug products. Validation can be a challenge because laboratory
computers become more and more automated and complex resulting in more demand
for validation. Therefore users of laboratory systems are looking for
cost-effective validation solutions with examples for all validation steps.
Key Questions for Laboratory Computers are:
- How to define a validation program for laboratory computers?
- What are FDA, EMA, USP and GAMP®
requirements?
- What and how much to test?
- Are vendor audits required?
- How to define risk categories?
- What exactly is included IQ/OQ/PQ
- Should we test standard functions of data systems?
- How to validate networked systems?
- How to validate existing systems?
- What to revalidate and document after changes?
- How to validate laboratory computers for Part 11 compliance?
- Are there any ready-to-use
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:
- FDA GxP, Part 11 and EU Annex 11 requirements for
laboratory computers - What do inspectors ask and what documents
should be available.
- Most frequently cited deviations related to laboratory
computers.
- Laboratory system validation according to GAMP®
and USP
- Developing a validation master plan for laboratory computers
- Writing user requirement specifications
- Validation steps with examples: DQ/IQ/OQ/PQ
- Recommendations for risk based validation.
- Validation of networked systems
- Validation of existing systems
- Maintaining laboratory systems in the validated state
- Validation of integrated instrument hardware and computer
systems
- Documenting validation steps from planning to reporting with
examples
And for easy and instant implementation:
download 10+ documents from special seminar website
- PowerPoint Presentation
- Script
- All questions and answers from before,
during and after the seminar
- SOPs:
- Validation of Laboratory Computer Systems
- Risk Assessment for Laboratory Systems
- Risk based validation of laboratory computers
- Periodic Evaluation and Review of Computerized Systems
- Retrospective Validation of Laboratory Computer Systems
- Gap analysis: Laboratory computers systems
- Templates/Examples for Chromatographic Data Systems
- Project plan
- Requirement Specifications
- Risk assessment
- Vendor qualification
- Installation qualification
- Operational qualification
- Performance qualification
- Test plan
- Test protocols
- Validation report
- FDA 483 inspectional observations and warning letters with
deviations related to laboratory computers
- FDA regulations and guidelines related to computers
- FDA Guidelines Related to 21 CFR Part 11
- And more....
A full set of 'ready-to-use' filled in validation examples
The seminar material includes full set of filled in validation
examples
Who should attend?
- Analysts and lab managers
- Validation specialists
- QA managers and personnel
- IT Managers and staff
- Regulatory affairs
- Training department
- Documentation department
- Consultants
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.-
|
|
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, |