Labcompliance On-line Audio Seminar
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On-line Audio Seminar 321
Integrated Analytical Equipment
Qualification and System Validation for FDA Compliance
Combining the USP <1058> with the new
GAMP(TM) Laboratory Computer Systems Guide
Recorded, available with all reference material
at any time
Analytical laboratory equipment and computer systems are amongst key targets of
FDA inspections. They are considered high risk systems because they can have a
high impact on product quality. Validation can be a challenge because laboratory
instruments become more and more complex and automated. In the past there was no
specific guidance on how to combine analytical instrument qualification with
system validation. This has changed. The USP Chapter <1058> on "Analytical
Instrument Qualification" is focused on equipment qualification and the new
GAMP/ISPE Good Practice Guide "Risk based Approach to GxP Compliant Laboratory
Computerized System" is more focused on automated systems. Both USP and
GAMP/ISPE are important FDA references but unfortunately the concepts are
different. So the question is: how to integrate?
Key Questions related to integrated analytical instruments and laboratory
systems are:
- What are FDA and international requirements for analytical
instrument qualification and laboratory computer system
validation?
- What are the approaches of the USP and GAMP for automated
laboratories?
- What are similarities and what are differences?
- What is the regulatory impact of both guids?
- Which one should we follow: the USP 4Q life-cycle model of
the GAMP combined integration/system development model?
- Is there a practical model, that can accommodate both?
- There is a lot of discussion about qualification vs.
verification: what to do?
- What are the industry recommendations and practices for new
and existing systems?
- Can we conduct equipment qualification by ourselves or
should must vendor do it?
- If we do it by ourselves do we need to get trained from the
vendor?
- If the equipment is repaired during warrantee period who
pays for requalification: the vendor or the user firm?
- What do the guides say about risk based testing abd how to
implement?
- What exactly are the defined instrument and system
categories and what should we test and document for each
category?
- We have heard that there was a proposal for an updated more
complex USP <1058>, what is the status?
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 on how to
effectively comply with both. 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 EU requirements for analytical automated laboratory
systems - What do inspectors ask and what documents should be
available.
- Most frequently cited deviations related to laboratory
equipment and computers.
- The role of GAMP(TM) and USP for the FDA and international
agencies
- Getting clarification of on the terminology: what to verify,
qualify and validate
- The approach of both guides
- Similarities and differences of both guides
- Presenting a model that accommodates both
- Easy identification of high, medium and low risk instruments
and systems
- Reducing validation efforts through leveraging vendor
documentation
- Savings through risk based testing
- The anticipated future of both guides
- Case studies: recommendations for 3 systems in different
categories
- life cycle deliverables
- vendor assessment
- testing before and during operation
- documentation requirements and 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:
- Integrated Analytical Equipment Qualification and System
Validation
- Analytical Instrument Qualification for USP <1058>
- Validation of Laboratory Computer Systems
- Risk Assessment for Laboratory Systems
- Gap analysis: Laboratory computers systems
- Case Study Integrated Analytical Equipment Qualification and
System Validation - Computerized HPLC System Step-by-Step
- Templates/Examples for Chromatographic Data Systems
- Project plan
- Requirement Specifications
- Risk assessment
- Vendor qualification
- Installation qualification
- Operational qualification
- Performance qualification
- Test plan
- Validation report
- FDA 483 inspectional observations and warning letters with
deviations related to laboratory equipment and computerized
systems
- FDA regulations and guidelines related to computers
- And more...
A full set of 'ready-to-use' inspection ready filled in
validation examples
The seminar material includes a full set of 'FDA Friendly'
validation examples
Who should attend?
- Analysts and lab managers
- Validation specialists
- IT managers and staff
- QA managers and personnel
- QCU directors and Qualified persons
- 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.
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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.-
|
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
Please forward to your colleagues
just
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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
 |
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, |