This site has testimonials related to Ludwig Huber's conference/seminar
presentations and publications
Kevin McNally, IT Manager attending the IVT Conference Electronic
Records/Signatures and Computer Validation
Hi Ludwig first of all let me say that I have just attended the Dublin
conference and to be honest I was genuinely surprised. I suppose, as an IT
person, I am always a little suspicious when dealing with Validation
experts. I have to say that I learned more with attending your talks this
week than I have learned in the last 4 years working in a regulated
environment. If only all people spoke as clearly and logically as yourself
then perhaps a lot of the confusion and fear would not exist anymore
I do appreciate the attention and service you give. It is very refreshing
these days to see such professionalism and dedication.
Kevin McNally, IT Manager
Fujisawa Ireland Ltd
Bansha, Killorglin, Co Kerry, Ireland
Jim Remillard, Information Systems Manager, Associates of Cape Cod, Inc.
Thanks so much for the ppt files with your network presentation. Our IS
department was impressed! The audit trail presentation is also excellent.
Our software development team will be studying these as we design our new
software. Now I don't feel so bad about missing your presentation because
the slides speak for themselves! You present some tough issues that IS
managers and software designers have to deal with to be compliant and it's
encouraging to see you take them head-on. Thanks again, Ludwig and I'll see
you at one of the upcoming IVT meetings.
Information Systems Manager
Associates of Cape Cod, Inc.
Sandra Harris, CV Therapeutics, about a Part 11 Seminar
A quick noteâ€¦ I have attended quite a few of your Webinars through IVT
and LabCompliance. I just wanted to tell you how much I have enjoyed them.
Youâ€™re a very good speaker and the content is always relevant to what I am
doing here especially with respect to Computer Systems Validation.
Senior Manager, QSC
CV Therapeutics, Inc.
Dr. Patrick G. McCormick, SkyePharma, about Ludwig Huber's 21 Part 11
Dear Dr. Huber
Having seen this one hour presentation, I must tell you it is the best
introduction to Part 11 I know of. It would be extremely helpful to
SkyePharma Inc if we could have a copy of this CD for use in our GMP
Patrick G. McCormick, Ph.D
Sr. Director, Global Quality Assurance
10450 Science Center Drive.
San Diego, CA 92121-1148, USA
Lindi Delquadri, Conference Producer, IVT
Your ppts are beautiful, beautiful, beautiful!
I have never come across any that are so clean, professional, and just
Evaluations at the IVT Conference Electronic Records/Signatures and
Computer Validation, Ireland, Dublin
(Evaluations came from the audience and have been submitted to the speaker)
Interactive Session: Using Macros and Spreadsheets in Regulated
- Awesome, very realistic
- Excellent presentation and resources. Will be using this material
for our spreadsheet/macro validation
- Very topical, addressed some of my specific concerns and offered
solutions and resources
- Good to learn about standard products that exist
- Interesting useful information, very detailed slides - may be too
much, but good examples and advice on usage
- Good info, appreciate the website links
- Very knowledgeable
Interactive session: How to Apply FDA's Recent Part 11 Interpretations
and Validation Guidance to Analytical Laboratory Computers
- Excellent presentation and useful material
- Very dynamic presentation, appreciate the quotes (text and audio)
from FDA Enforcement
- References and info available on website useful for applying on site
- If there were a 6 in content, I would have given it to him
- Excellent session! May be the best of the conference
- Provided great resources for the subject
- Very beneficial. Great information to take back to the workplace
- Very well prepared! Good to have access to forms/lists etc to use.
This is the most valuable piece of conferences!
- Questions interrupted presentation, leave to end of presentation is
Vandana Bhatia, K Merck & Co., Inc., about books from Ludwig Huber
I want to thank you for writing the best validation papers that one can
follow so easily, and also understand with the first reading. I save my
salary to purchase your material and have been applying your concepts and
techniques within my company for QA AND VALIDATION.
Thank you once again
Vandana Bhatia, QA Validation, K Merck & Co., Inc.
Doug Finner, KMC Systems Inc.About the Validation
Our remediation team finds the VMP (Validation Master Plan) to be a very
complete and well written document. As the project leader for our
remediation effort, I find that the document moves the discussion away from
'what does Doug say we should do - why does he say that' to 'how do we best
create an environment that fits our needs'; it really makes the discussions
more issue rather than person focused and I thank you for providing that
Stephanie Brown, Quality Chemlabs, about the
Chapters 1 & 2 are excellent tools for training new employees -
especially those that are new to the GMP environment. The entire guide is an
excellent resource when generating SOPs when used in conjunction with the
CFR and FDA guidelines. Our plan is to incorporate some of the info
presented in your primer into our initial training for new employee
Dr. David Grace, Nycomed Amersham Imaging
To Ludwig Huber:
I have recently downloaded a copy of your GLP and cGMP primer which I am
part way through reading at the moment I also am reading your Validation and
Qualification in Analytical Laboratories which we have purchased. I really
must congratulate you on and thank you for the clarity of your explanations
and the wealth of examples and practical suggestions - I have some knowledge
in the field but need a lot more and both these publications are ideal for
Dr. David Grace
Nycomed Amersham Imaging
NMR group, Oslo
Joel C. Harder, Quality Assurance Associate at the United
States Red Cross,
Joel is involved at the headquarters level in developing policy
pertaining to a validation program.
I utilize L. Huber's articles (the ones that I am aware of) to provide
guidance to the field in an effort to provide further understanding of
validation principles. Using his articles as a base (in addition to many
others) has improved our organizations understanding of validation
principles. The field struggles at times getting the language since it is
pharmaceutical based but I am happy to report that there are positive end
results. Hence, I believe that efforts on his part to continue to generate
comprehensive and concise articles has increased the safety of the blood
supply, which in my opinion is very safe. I appreciate his efforts and look
forward to reading more of his articles pertaining to validation principles
in general. Thanks.
Michelle Bailey, Sr. Validation Specialist, Validation
Systems Inc., Palo Alto, CA
There are many good references that exist on the topics of HPLC Calibration
and Validation. They are two different areas, but they go hand in hand. Of
the references I have reviewed the best written and easily understood are
those published by Ludwig Huber Ph.D., an expert in the field. I highly
recommend the two books he's published: "Validation of Computerized
Analytical Systems", Interpharm Press, 1995 "Validation and Qualification in
the Analytical Laboratory", Interpharm Press, 1998 He has written and
collaborated on a great number of articles in LC-GC, Biopharm and other
reputable reference sources. He has a website at www.labcompliance.com. You
should try this site as a starting point.
Dan Berdovich, QA/Regulatory Affairs Mgr , Micro
Measurement Laboratories, Wheeling, IL
Your book "Validation of Computerized Analytical Systems" shed more light on
the issues involved in validating particle sizing and particle counting
equipment than any other single publication I've read. I've been able to
help several of our clients sort out many issues involving routine
qualifications with these instrument.
Dr. Herman Lam, Ph.D., Book Review for Lab Focus Magazine
Book Title: Validation and Qualification in Analytical Laboratory.
Author: By Ludwig Huber
(Interpharm Press, Inc. Buffalo Grove, IL, USA., 1999, ISBN: 1-57491-080-9)
This book is an excellent guide to two very important aspects of
instrumental analysis: Instrument Qualification and Method Validation. The
reliability of the data is critically affected by their proper execution.
The first three chapters cover analytical system validation strategy, cGMP
requirements, and the expectations of regulatory agencies and international
quality establishments such as ICH and ISO. Chapters 4 to 7 provide
comprehensive coverage in the approaches and requirements for Design
Qualification (DQ), Installation Qualification (IQ), Operation Qualification
(OQ) and Performance Qualification (PQ). The qualification of an HPLC system
is used as an example to assist understanding of the qualification
processes. In addition, a very useful list of OQ testing and acceptance
criteria for a wide range of analytical laboratory instrumentation, and
selected case studies are included in appendix B and D. Qualification of
software, including the use of Macros, and computer systems are briefly
discussed in chapter 8. Details on computerized system validation can be
found in Dr. Huberâ€™s book on "Validation of Computerized Analytical System"
published in 1995 by Interpharm Press Inc.
Although the principles and practices of analytical method validation have
been extensively discussed in the literature, the presentation of these
topics in chapter 9 of the book is well organized and easy to follow. It
provides a stepwise guide to perform validation for quantitative and
qualitative methods. Subtle differences in some of the validation parameters
such as selectivity and specificity; as well as reproducibility and
repeatability are well defined and explained.
The useful discussion on the use of reference standards, their traceability
and certification in Chapter 11 are definitely worth reading. It helps to
clarify some of the key concepts in the use, selection and generation of
reference standards in the GMP analytical laboratories.
Dr. Huber's new book on Validation and Qualification in Analytical
Laboratory is a very resourceful reference. As a lab manager, who oversees
instrument qualification and system validation in pharmaceutical R&D
laboratories, I strongly recommend this book to all scientists working in
the fields of analytical instrument qualification and method validation.
Herman Lam, Ph.D.
Public Relations Director
Calibration & Validation Group
Elisabeth B. Goncalves, Embrapa, Brazil
Dear Dr. Huber,
Thanks for the book chapter.
I have read your article about Validation of Analytical Methods.
I found it very useful, I do not have my doubt about validation of standard
Elisabeth B. Goncalves