A good relationship with industry and FDA has always been my
highest priority. Most issues between industry and FDA can
be resolved by having a good understanding of each others
position. Personal visits to FDA's centers in Rockville,
panel discussions at public conferences, joint industry/FDA
workshops and having FDA and industry guest speakers in the
Labcompliance audio seminars helped a lot to get a real good
understanding on both positions, and to get an insight on
This website shows examples of interactions with the FDA.
||Ludwig Huber and
Paul Lepore, FDA's 'Father of GLP' during a GLP Workshop in
Paul Lepore told the audience how they should prepare for a
GLP inspection and what inspectors will ask.
Ludwig Huber explained how to implement computer validation
in GLP environment.
||Nick Buhay, Acting
Director in FDA/CDER's Division of Manufacturing and Product
Quality, and Ludwig Huber in the Q&A Discussion Session on
||Ludwig Huber was
on conference program's Part 11 panel discussion with FDA's
the Joseph Famulare, Acting Director, Office of Compliance,
(right) , QA manager at the FDA Labs in Puerto Rico, and
author of FDA's Excel Bulletins spoke at Ludwig Huber's
seminar as guest speaker.
2005 and in 2009
||Ludwig Huber has
been asked to review FDA's internal SOP and Lab Information
Bulletin on Spreadsheet Validation.
FDA acknowledged Ludwig Huber's contribution in the LIB
||Thomas S. Savage,
Senior Coordinator at FDA's Office of Regulatory Affairs,
told the audience that he took quite a lot of material from
Ludwig Huber's Labcompliance website. He also said that he
regularly visits this website when he wants to learn about
news on FDA inspections.
||Ludwig Huber in an
joint industry/FDA panel discussion at the IVT Part11
conference in Washington DC: From right to left: Martin
Browning, fEduQuest Inc, Paul Motise, US FDA, Kathryn
Davidson. Baxter Healthcare, INC, and Ludwig Huber fAgilent,
||Ludwig Huber (middle)
with FDA's Paul Motise (second from left) and the speaker
panel at an IVT conference in Washington (2002). Other
speakers, from right to left: Chris Reid, Rebecca Fuller
Heyde, and Jeff Beck
|Video Clips with
FDA Management are on the Lab Compliance Website
FDA management explained FDA's 21st Century Drug cGMP
initiative and the impact on Part 11
Mark B. McClellan, MD., PhD; Commissioner of Food and Drugs,
Janet Woodcock, MD. ; CDER Director David Horowitz, Director
of CDER's Office of Compliance, Joseph Famulare, Director,
Div. of Manufacturing & Product Quality Office of
||Ludwig Huber (right)
and John Murray, FDA, (left, speaking at the IVT Computer
System Validation Conference
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)
in a panel discussion with FDA inspectors and directors:
Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare, and
Nicholas Buhay, Acting Director in FDA/CDERs Division of
Manufacturing and Product Quality.
Ludwig Huber (right) with Dr. Robert C. Horan, FDA,
Nicholas Buhay, and Joseph Famulare, in the joint
SINO-SFDA-US FDA cGMP /workshop
Ludwig Huber has been invited by FDA’s CDER to give a
seminar for FDA Quality Professionals
The idea was to share Ludwig’s expertise in the area of
laboratory controls, computer validation and integrity of
In 2007 Dr. Ludwig Huber has been invited by FDA's Eric
Hendrikson to give a post conference tutorial at the annual
GMP conference organized by FDA professionals.
Two FDA professionals attended Ludwig's tutorial.
Dr. Brenda Uratani, Assistant Country
Director US FDA China Offices, and Accociate Prof. Mr. Wang Yamin,
Center for Drug Evaluation, SFDA attended Dr. Huber's GMP compliance
workshop at the Bejing University.
Here Dr. Ludwig Huber (left) at lunch with Dr. Brenda Uratani, , and with Accociate Prof. Mr. Wang Yamin,