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Working with the FDA

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 what's coming.

This website shows examples of interactions with the FDA.

 

Ludwig Huber and Paul Lepore, FDA's 'Father of GLP' during a GLP Workshop in Tokyo.

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.
1999
Nick Buhay, Acting Director in FDA/CDER's Division of Manufacturing and Product Quality, and Ludwig Huber in the Q&A Discussion Session on Laboratory Compliance

Ludwig Huber was on conference program's Part 11 panel discussion with FDA's the Joseph Famulare, Acting Director, Office of Compliance, CDER.

Dennis Cantellops (right) , QA manager at the FDA Labs in Puerto Rico, and author of FDA's Excel Bulletins  spoke at Ludwig Huber's Excel audio 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, 1999
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
2002


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 Compliance, CDER/FDA


Ludwig Huber (right) and John Murray, FDA, (left, speaking at the IVT Computer System Validation Conference


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.
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 electronic records
  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,