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Workshop attendees receive 10+ Best Practices Reference Documents for easy .They help to easily implement what they have learned in the workshop

 

 

 

 

 

 

 

Reference material includes examples from most recent 483's and warning letters related to electronic audit trails

Interactive Compliance Workshops

For Professionals in the (Bio)pharmaceutical and Medical Device Industry

  •  All in one: theory - practice - tool kits for easy implementation
  • Learn about theory and strategies from the FDA expert
  • Practice through workshops through case studies and examples
  • Use the 10+ best practices tool kit for easy implementation: SOPs, examples, templates, checklists
  • Courses are delivered on demand, at any time, anywhere in the world

Compliance Workshops Overview

Topics are related to FDA and equivalent international compliance. Topics range from basics of GLP and GMP to special topics such as equipment qualification and software and computer system validation and most recent updates on electronic records and signatures (Part 11).

We also offer a two day course for all aspects of compliance in analytical and QC laboratories. The courses are offered worldwide to all Pharmaceutical, Biopharmaceutical and medical device companies for in-house training, but also for institutes and seminar providers which are experienced in organizing and hosting any type of seminars, courses and conferences located anywhere in the world.

Our compliance workshops differentiate from other courses and seminars through

  • a lot of practical work, ranging from going through examples and case studies to collaborative workshops built into each training module.
  • extensive hand-outs that not only include electronic copies of the slides but also 10+ best practical documents such as SOPs, case studies, validation examples, checklists and master plans.
  • All courses are developed by Dr. Ludwig Huber, IVT's presenter of the year.

The theme of all courses is: Put theory in practice through case studies, workshop exercises and tool kits for easy implementation.

For more information on contents, pick one or more of the topics from the titles list below.

Organization

  • Workshops are prepared and delivered by Labcompliance
  • Organization such as advertizing and providing facilities is made by Organizers
  • 'Organizers can be institutes, professional conference providers or regulated companies for in-house training

For general information on terms and conditions, send a e=mail to
ludwig_huber@labcompliance.com

Workshop Titles

Location

  • On demand, anywhere in the world
  • Exact locations will be defined by organizers

Dates

  • On demand, subject to availability of the speaker(s)

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More info?

If you are interested in any of the Labcompliance workshops, please use the contact form below.

If you have any specific question, please contact us at +49 7802 980 582.

   

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About the speaker: Dr. Ludwig Huber

  • Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
  • Team and/or review member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Equipment
  • Presenter of the Year of the Institute for Validation and Technology
    Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues.
  • Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
  • For more information on Ludwig Huber, e.g., achievements and relationship with FDA, click here.
  • For testimonials, click here
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 IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.