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 349
FDA Compliant HPLC
Qualification and Performance Testing
Learn how to select,
conduct and document the right tests in the right sequence
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 qualify and test HPLC
systems,
click here
Introduction
High Performance Liquid Chromatography is the most frequently
used analytical tool for pharmaceutical and API testing laboratories. FDA and
international agencies require HPLC equipment to be calibrated, qualified and
tested to ensure accurate and reliable analytical results. Even though this is
well known since long time, laboratories are unsure on what exactly should be
tested initially and on an on-going basis. The main challenge is to do the right
testing in the right sequence.
Key Questions related to HPLC Qualification and Performance
Testing are:
- What does FDA say about HPLC calibration,
qualification and testing?
- What exactly are the expectations of
inspectors?
- What is the difference between
calibration, qualification and testing?
- Why should we qualify HPLC equipment if
we perform system suitability testing every day?
- Which parameters should be tested and
what are the acceptance criteria?
- Should we test parameters over the entire
range, or is it enough to test at one point?
- How to optimize all the tests and
sequence for highest efficiency and compliance?
- When and how much should we re-qualify,
e.g., after repair, or after instrument move?
- Who can or should test HPLCs, the vendor,
user, 3rd party?
- Do we also need to qualify HPLC used in
R&D?
- What to test after changes, e.g., when
the equipment is moved, repaired or updated?
- We want to use our non-qualified HPLCs
for regulated work, what should we do?
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 an overview and give practical
recommendations. After the seminar, an extensive list of reference
material like SOPs, test scripts, templates and examples will help
immediate and cost effective implementation.
During the interactive presentation you learn
about:
- FDA and equivalent international
requirements
- Examples for recent 483s and Warning
Letters
- HPLC qualification according to USP
<1058>
- Calibration/qualification phases: design
qualification, installation qualification, operational
qualification, performance qualification
- Selecting parameters and acceptance
limits for HPLC initial and on-going testing
- Recommended test sequence for highest
efficiency
- Approach for existing systems
- Approach for automated systems (incl.
firmware/computer systems)
- Requalification after equipment changes
(move, repair, firmware upgrade, hardware upgrade)
- Documentation requirements
And for easy and instant implementation:
download 10+ documents from special seminar website
- Example SOPs:
- Qualification of High Performance Liquid Chromatographs
- Testing of High Performance Liquid Chromatographs
- Change control for analytical equipment
- Development and Maintenance of Test Scripts for Analytical
Systems
- Eight templates/examples - HPLC System
- HPLC System - Validation plan
- HPLC System - Requirement Specifications
- HPLC System - Vendor assessment
- HPLC System - Design Qualification
- HPLC System - Installation Qualification
- HPLC System - Operational Qualification
- HPLC System - Performance Qualification
- HPLC System - Test Sheet
- HPLC System - Summary report
- Equipment Validation Master Plan
- Reference Articles
- Selecting Parameters and Limits for Equipment Operational
Qualification
- Operational Qualification in Practice
- Warning letters and Inspectional
observations related to HPLC testing.
- FDA Publication: Overview of Equipment
Qualification, Including HPLC Testing
- Seven Examples for FDA Warning Letters Related to HPLC
Testing
OQ Testing - HPLC Fluorescence Detector
All
HPLC modules should be tested as part of the system. Here is an
example for the fluorescence detector. Attend the seminar to learn
about test parameters of other modules.
Who should attend?
- Laboratory managers and staff
- Analysts
- QA managers and personnel
- Regulatory affairs
- Training departments
- 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.-

|
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.-

|
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.
- Dr. Beatrisa Aronchik,
Affymax, QC manager, USA
The seminar did exceed my
expectations
The presented slides outlined all aspects of the current
requirements to the HPLC qualification. The presenter
demonstrated great knowledge in the topic during the
presentation and Q&A session. As a QC
lab manager I have a lot of experience with the HPLC system
qualification and was happy to see that we follow the
recommendations. Thank you for a great audio seminar. I really
appreciate your website that has many useful links.
(Ref
1037)
- Mr Daniel Hollingshead,
AMT Labs, Inc.,
Lab Supervisor. Analytical Lab
The seminar provided clear
and concise information. Templates will make it very easy to
implement qualification and performance
testing program.
You have a very impressive list of topics.I look forward
to purchasing additional seminars in the near future.
(Ref 1101)
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.
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. |
.
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
 |
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, |