In-Person Seminars for ComplianceOnline

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Selection of Best Practices Reference Documents: All included in both or one of the courses.

 

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

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

In 2014 ComplianceOnline has scheduled 12 In-person seminars in America, Europe and Asia with Dr. Ludwig Huber as presenter

Dates, locations and links to related ComplianceOnline websites with details on content, agenda, target audience speaker, pricing and registration

Dates

Topic

Location

June 16/17

GMP Compliance for Quality Control and Contract laboratories

Amsterdam

June 12/13

Analytical Instrument qualification and System Validation

London

May 19&20

Analytical Instrument qualification and System Validation

Boston, MA

May 22&23

GMP Compliance for Quality Control and Contract laboratories

Boston, MA

August 4&5

GMP Compliance for Quality Control and Contract laboratories

San Diego, CA

August 7&8

Analytical Instrument qualification and System Validation

San Diego, CA

September 18&19

GMP Compliance for Quality Control and Contract laboratories

Hong-Kong

September 22&23

Analytical Instrument qualification and System Validation

Singapore

October 16&17

GMP Compliance for Quality Control and Contract laboratories

Chicago, IL

October 20&21

Analytical Instrument qualification and System Validation

Chicago, IL

December 1&2

GMP Compliance for Quality Control and Contract laboratories

San Francisco

December 4&5

Analytical Instrument qualification and System Validation

San Francisco

     

Additional benefits (value up to $649)

Attendees will receive at no additional charge a number of best practice documents that help to easily implement what they have learned in the course. For example, attendees of the course GMP Compliance for Quality Control and Contract laboratories will receive a complete Labcompliance Laboratory Compliance Package (regular price $649) and attendees of the course Analytical Instrument qualification and System Validation will receive 15+ "Best Practice Guides" such as a 60-page primer, SOPs, checklists, templates and validation examples.

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 1
(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 also 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, SFDA 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,