In-Person Seminars with Dr. Ludwig Huber

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Selection of Best Practices Reference Documents: All included in at least one of the courses.

 

Reference material includes examples from most recent 483's and warning letters related to laboratory compliance regulations

Ten Two-Day Interactive In-Person Seminars with
Dr. Ludwig Huber

In 2015 ComplianceOnline and Globalcompliance Panel  have scheduled 6 In-person seminars in America, Europe and Asia with Dr. Ludwig Huber as presenter
ILabcompliance has schefuled 4 seminars in Europe and Asia.

For content, agenda, target audience, speaker, pricing and registration click on the links below

Dates

Topic

Location

Jan 19/20

Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data

Singapore
completed

April 13/14

Analytical Instrument qualification and System Validation 

San Diego, CA
completed

April 15/16

GMP Compliance for Quality Control and Contract laboratories

Boston, MA
completed

April 28/29

Validation and Part 11/Annex 11 Compliance of Computerized Analytical Systems and Data

Zurich
Switzerland

July 27/28

Analytical Instrument Qualification and System Validation

Philadelphia, PA

July 30/31

GMP Compliance for Quality Control and Contract laboratories

Chicago, IL

September 01/02

Validation and Part 11/Annex 11 Compliance of Computer Systems

Dublin
Ireland

September
22/23

Validation, Verification and Transfer or Analytical Methods

Prague
Czech Republic

November
09/10

Validation and Part 11/Annex 11 Compliance of Computer Systems

Singapore

November
12/13

Validation, Verification and Transfer or Analytical Methods

Singapore

     

Additional benefits (value up to $649)

Attendees will receive at no additional charge 30+ best practice documents that help to easily implement what they have learned in the course. The documents include SOPs, checklists, validation examples and master plans. Total value of the documents is up to $800. For details check the related websites.

What to do

Just look, select and click at one of the links in the table above, register, and once you will attend, please say hello to Ludwig Huber.

Comment from an attendee of a previous seminar
(sent by e-mail to Dr. Ludwig Huber)

I attended your 2 day seminar on AIQ and CSV in Boston on 29-30 August 2013. I first would like to thank you for the experience as I truly got tons of valuable information which I have been able to use to address many gaps in my department’s qualification and validation projects. I presented some of the finer points to the members of my team when I returned to the office last year, and we have been making continuous improvements since then.
(Dan Kirk, QC Lead, Lonza Biologics, Inc., Portsmouth, NH 03801 )

About the presenter

Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the on-line resource for validation and laboratory compliance. ,

  • He studied chemistry and received his PhD. from the University of Karlsruhe, Germany.  He is the author of the bestselling books “Validation of Computerized Analytical Systems” and “Validation and Qualification in Analytical Laboratories,”. 

  • He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA (Rockville), ISPE, GAMP, PDA, PIC/S, MFDS, Korea, CFDA China, FDA Philippines, HSA Singapore,  and several national health agencies. For more information, please check the website:
    http://www.ludwig-huber.com

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from an IVT conference conference with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

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) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,