- Author and editor of www.labcompliance.com, the
leading global online resource for validation and compliance in
- Was responsible for the worldwide FDA compliance
program at Hewlett Packard and Agilent Technologies. Hewlett-Packard and
Agilent have been ranked several times as number one supplier for
compliance in analytical instrumentation
- Was responsible at Agilent Technologies for
Worldwide Product Marketing of HPLC and Pharmaceutical Solutions. During
that time Agilent's 1100 Series HPLC became the best selling HPLC in the
- Author of Labcompliance Best Practices "21 CFR
Part 11 Compliance Package"
- Author of the three validation reference books
from Interpharm/CRC: "Validation of Computerized Analytical Systems",
"Validation and Qualification in Analytical Laboratories", and
"Validation of Computerized Analytical and Networked Systems",
Interpharm Press, 1995, 2007 and 2002. Best sellers at Interpharm.
- Did hit the record of Agilent's Video Webseminars
with more than 2000 registrations: Title "Analytical Instrument
Qualification According to USP <1058>.
- Author of Labcompliance Best Practices: "Network
Quality Package" and "Validation Master Plan"
- Author of Labcompliance Best Practices "Macro and
Spreadsheet Quality Package"
- Author of Labcompliance Best Practices "FDA
Inspections" and "Risk Management Master Plan"
- Author of "GLP and cGMP in Analytical
Laboratories", with more than 130 000 copies distributed
- Winner of the "First International GLP Award"
from Indian Drug Manufacturer Association for Publications and
Presentations in the Area of GLP and GMP
- Consultant for the industry and regulatory
agencies on compliance issues.
- Did hit the record of IVT's tele-seminars with
more than 180 registrations: Title "Analytical Instrument Qualification
According to USP <1058>.
- Member of the US PDA task force on 21 CFR Part11,
- Member of the GAMP America, special interest
group: lab equipment
- Member of IVT task force 2003: IT
- Member of scientific advisory board of IVT's GxP
- Board member of 21CFRPart11 Compliance -
- Board member of Pharmaceutical Technology Europe
- Member of the advisory board for the European
Compliance Academy (ECA)
- 'Presenter of Year' selected by thousands of IVT
- Winner of the Wallhaeusser award, sponsored by
the European Compliance Academy for award for publications in the area
of 'Quality and Safety of Drugs'
- Presenter of six interactive videos: "21 CFR Part
11", "Validation of Analytical Methods", "Validation of Computerized
Analytical and Networked Systems", "Validation and Qualification in
Analytical Laboratories", "Validation and Qualification of Networks and
Networked systems" and "Using Macros and Spreadsheets in a Regulated
- Presenter of the 2004 Video Web Seminar: Risk
Based Validation of Laboratory Systems with more than 1500 attendees
- Presenter of the 2006 Video Web Seminar:
Analytical Instrument Qualification (USP 1058) with more than 2000
- Presenter or more than 150 live on-line audio/tele/video
Ludwig Huber has studied chemistry and
received his Ph.D. from the University of Karlsruhe,
Germany. He has been working for Hewlett-Packard and Agilent
Technologies as applications chemist, product manager and
marketing manager for several analytical instruments.
As Agilent's Worldwide Compliance Fellow he also was
reponsible for the FDA and ISO 17025 compliance. He has
published more than 100 papers on validation and compliance
and 21 CFR Part 11 and is the author of several books, such
as Validation and Qualification in Analytical Laboratories
and Validation of Computerized Analytical and Networked
Systems. He is also the author and editor of
www.labcompliance.com the on-line resource for validation
and compliance issues in laboratories. Dr Huber has been a
member of the PDA Task Force on 21 CFR Part 11 and of the
GAMP Special Interest Group on Laboratory Equipment and
currently he is on the advisory board of the European
Compliance Academy and was a member of the IVT task force on
Some people may think I am an IT
specialist or a QA person because most of you know me from
my presentations and publications on GLP, GMP, and
validation of computer systems. However, I am just a chemist.
Even I have to admit that I lost most of my scientific
knowledge, I still think as a chemist !
I received my Master of Science in Chemistry in 1975 and my
Ph.D. in Chemical Engineering in 1978 from the University of
By far the most important and most lucky step in my
professional life was to join HP's Chemical Analysis Group (now
part of Agilent Technologies) in 1978. I started as an
Applications Chemist for Gas Chromatography. I have been
working for Hewlett-Packard and Agilent was very happy to be
an employee of this excellent companies. What I like most ws
the freedom to do what I wanted, as long as my customers are
happy with me. I also appreciated the continuous support of
my managers, especially Dr. Guenter Nill.
One of my key previous positions was
Worldwide Product Marketing Manager for HPLC products and
environmental and pharmaceutical industry markets at
Hewlett-Packard and Agilent Technologies. Amongst other
products I was responsible for the very successful 1100
Series HPLC, at that time probably the world's most
frequently sold HPLC modules and systems.
Since 2008 I have been entirely focusing
on providing compliance expertise to industry, testing
laboratories and to regulatory agencies all over world. I am
doing this through public conferences, targeted on-site
seminars, audio- and web seminars, but also through on-line
newsletters, books and video seminars,.
Taipei, World Trade Center at signing one
of my books.
As part of my job as Product Marketing
Manager for the pharmaceutical industry at Agilent technologies
I spent quite some time to find out what our customers need to
meet regulatory requirements. Together with colleagues from R&D,
marketing, quality assurance, from other HP divisions and from
our sales and service organizations we developed products and
services to meet these requirements.
I am writing a lot! I am the author of more than 100
publications dealing with GC, HPLC and regulatory and quality
standard compliance in the analytical laboratory.
At the beginning of my professional live I focused on special
techniques in gas and liquid chromatography. For example, I
wrote, contributed to and edited the books 'Applications of
Diode-Array Detection in HPLC' (1990), published by
Hewlett-Packard, 'Diode-Array Detection in HPLC' (1993) and
'HPLC in Pharmaceutical Industry', (1992), published by Marcel
Later on I specialized in GLP, GMP and Accreditation. In this
area I wrote the book 'Good Laboratory Practice and Good
Manufacturing Practice for HPLC, GC, MS, CE and UV/Vis
Spectroscopy', published by Hewlett-Packard in 1994. Meanwhile
the book has been translated into ten languages and over 130,000
copies have been distributed, mainly to the pharmaceutical
The book 'Validation of Computerized
Analytical Systems' published by Interpharm in May 1995 became
Interpharm's number one bestseller in 1996. The second book is
entitled 'Validation and Qualification in Analytical
Laboratories'. It has been published in November 1998 and became
'THE Standard reference book on validation and qualification in
analytical laboratories'. The most recent publication is the
book entitled 'Validation of Computerized Analytical and
Networked Systems'. It has been published in April 2002 and has
the potential to become 'THE Standard reference book on computer
validation and part 11 compliance for analytical laboratories'.
Currently I am working on a new edition of the book 'Validation
and Qualification in Analytical Laboratories' for publication in
Since 2002 I have been developing complete
compliance solutions on specific topics such as network
qualification, risk assessment, FDA Inspections, for laboratory
compliance, for Part 11 compliance, for Computer System
Validation and spreadsheet compliance such as Excel. Solution
elements include video presentations and primers to get a good
understanding and SOPs, checklists, templates and examples for
easy implementation. They are available from the Labcompliance
I am traveling a lot ! I give
presentations mainly on GLP/GMP, 21 CFR Part 11, ISO 17025 and
Validation around the world. I prepared and mostly presented
Hewlett-Packard's and Agilent's popular seminar series on
'Validation in the Analytical Laboratory - to meet regulatory
and quality standard requirements'. The series has been
presented world-wide in more than 30 countries to more than
10,000 attendees. Copies of the slides have been distributed by
the World Health Organization (WHO) in preparation for the
development of new validation guidelines.
I have been sharing and/or still share my
expertise with different organizations. They include:
International Society for Pharmaceutical Engineering (ISPE),
Parenteral Drug Association (PDA), US FDA (United States Food
and Drug Association), Pharmaceutical Inspection Convention and
Cooperation Scheme (PIC/S), Indian Drug association, the
European Compliance Academy (ECA), and the Institute for
Validation and Technology (IVT), and
Most recently I share my experience in
on-line audio seminars. These are one hour seminars delivered
over the telephone. Topics are basics of compliance like FDA
Inspections, SOPs, Master Plan, Change Control, CAPA and
selected new topics like various aspects of risk analysis. The
real value of these seminars comes from the handout material.
This includes 10+ documents like SOPs, examples, templates,
checklists, reference papers and regulatory documents. So far I
have delivered over 120 such seminars.