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

Seven Two-Day Interactive In-Person Seminars with
Dr. Ludwig Huber in the next six months

For the next six months ComplianceOnline and Globalcompliance Panel  have scheduled 7 two-day In-person seminars in America and Europe with Dr. Ludwig Huber as presenter

Zurich, San Francisco, Washington DC, Boston


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

Dates

Topic

Location

June 2017
07/08

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Zurich
Switzerland

July 2017
12/13

Validation and Part 11 Compliance of Computer Systems and Data

Zurich
Switzerland

Sept 2017
12/13

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

Boston
USA

Sep 2017
14/15

Analytical Instrument Qualification and System Validation

Boston
USA

Sep 2017
27/28

Data Integrity: FDA/EU Requirements and Implementation

Zurich
Switzerland

Oct 2017
09/10

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)

SFO
USA

Oct 2017
12/13

Data Integrity: FDA/EU Requirements and Implementation

Washington DC
USA

     

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 )
For more testimonials on Ludwig Huber's seminars: click here

Dr. Ludwig Huber's seminars are quite popular

Typically the number of attendees ranges between 20 and 30, sometimes there are much more like the session in Mumbai 2016 was attended by 272 professionals from Pharmaceutical, API and Device industry (see photo below)

Dr. Ludwig Huber's seminars are quite interactive

  Interactive discussion sessions and workshop exercises are interposed between presentations
Here attendees work together in small groups to define Part 11 requirements for systems selected by attendees
   

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,