Ludwig Huber - IVT's Presenter of the Year
On November 5, Ludwig Huber, worldwide product marketing
manager of Agilent Technologies, received the Industry Award
'Presenter of the Year' from the Institute of Validation and
Technology, the leading global publisher and probably by far the best
conference provider for validation and compliance.
This award has been presented by Glenn Melvin, president of
IVT, during a special awards banquet in the historical
Rosegarden ball room of the Hyatt Hotel in Philadelphia.
Throughout 2002, Ludwig Huber gave 14 presentations at IVT's
conferences in North America, Europe and Japan.
As Glenn Melvin said, "Ludwig Huber dominated the scores of
all presentations he was presenting at". The presentation on
network qualification was attended by 320 people and had the
highest score in the history of IVT conferences. Other
presentations included topics like FDA and EU regulations,
e-records management, risk assessment, various aspects of
computer validation, contributions of vendors, using the
internet in a regulated environment and using macros and
spreadsheets in a regulated environment.
Glenn Melvin gave four reasons for the overwhelming success of the presenter:
- Using excellent reference material through the Labcompliance website.
They include SOPs, checklists and Internet references.
- Using most modern multi-media presentation tools like video clips with
- Giving clear step-by-step directions on how to implement the regulations
and guidelines rather than spending time on theory.
- Humor. Glenn gave an excellent example for the humor citing his multiple
answers to the question 'how much testing is enough' during a network
Competition for the award
The competition for this award included 165 presenters. They came from the
pharmaceutical industry, industry task forces and from the US FDA
IVT and it's conferences
IVT is dedicated to validation and compliance mainly for FDA and other
regulations related to the pharmaceutical industry. The organization publishes
journals and books and organizes highly professional conferences around the
- Typically, 90% of conferences attendees come from the pharmaceutical and
medical device industry.
- They are mainly managers and other professionals from development and
manufacturing departments, but also from IT and QA departments and from
analytical development and QC laboratories.
- For example, about 60% of the conference attendees on Network
Infrastructure Qualification were IT professionals.
For more information on the publications, journals and books of the Institute
of Validation and Technology (IVT) go to the IVT website.
Ludwig Huber's presentation titles at IVT conferences
- Using the Internet in a Regulated Environment
- Validation of Networked Systems in a CNI qualified environment
- How to Apply FDA's Recent Part 11 Interpretations and Validation
Guidance to Analytical Laboratory Computers
- Qualification of network infrastructure and validation of networked
- Using Macros and Spreadsheets in Regulated Environment
- Design and validation of a chromatographic data system for compliance
with 21 CFR Part 11
- Response of the Pharmaceutical Industry in Europe and in United States
to 21 CFR Part 11
- Understanding and implementing Recent Part 11 guidance documents
- Part 11 Compliance with Audit Trail Requirements of Part 11
- Operational Compliance for Legacy Systems
- Validation and Qualification of Networks and Networked Systems
Infrastructure Qualification, Philadelphia, October 9, 2002
with more than 300 attendees
With an average score of 4.65 out of 5, this presentation
was ranked as the 'best' in the long history of all IVT
Infrastructure Qualification Philadelphia, October 9, 2002
Ludwig's presentations on network and internet compliance
were supported through video clips with FDA officials, here
Validation and E-Records &Signature Conference,
Washington, April 22, 2002
Ludwig Huber in the Hilton's VIP Speakers' Lounge with Paul
Motise from the US FDA
(middle) and Jay King from J&J (left).
a workshop on Network Qualification & System Validation at
the Washington CVS/ERES&ESIG Conference..
Ludwig's workshops had the highest attendance in 2002, here
more than 100 professionals.
IVT also took the conference on CSV and E-Records&
and Signatures to Japan
The slides were shown on two screens in English and
Japanese. Ludwig Huber gave six presentations out of 24 in
Tokyo, February 26, 2002
conference dinner in Tokyo has been sponsored by YAN/Agilent
February 26, 2002
president of IVT, opens conferences.
Here at the CSV/
E-SIG&Records conference in Washington.
Glenn is also the editor of IVT's popular GxP and Validation
Washington, April 28, 2002
||Paul Motise from
the US FDA is a regular presenter at IVT conferences.
Here at the CSV/E-SIG&Records conference in Washington. He
explained FDA's Part 11 Guidance documents.
Washington, April 28, 2002
Signatures was attended by about 250
professionals, mainly from the pharmaceutical industry
Ludwig spoke about validation of lab computers, networks and
Dublin, Ireland September 24, 2002
||Ludwig with his
wife Maria and son Philipp at the Awards Banquet in the
Rosegarten of the Philadelphia hotel.
Philadelphia, Nov 5, 2002
thanking IVT conference delegates and IVT for the award.
Special thanks went to John Kirchner of IVT for excellent
Philadelphia, Nov 5, 2002
||Ludwig Huber with
Kristen Evans, Investigative Engineer, U.S. Food and Drug
Kristen gave a presentation entitled: "FDA Inspections and
Trends Related to Pharmaceutical Validations"
||Ludwig with John
Kirchner, Vice President and Director of IVT's conference
John is the driving force behind the overwhelming success of
His creativity and innovation keeps IVT's validation&
conferences ahead and ensures attendees to stay on top of
ever changing regulations and guidelines
It's a pleasure to work with him.
Nights after long working days are very popular amongst
conference attendees. One 'little detail' how IVT cares
Here Ludwig playing "Black Jack" with his sun Philipp
(right) during the Validation Week in Philadelphia
Philadelphia, Nov 4, 2002