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Workshop attendees receive 30+ Best Practices Reference Documents. They help to easily implement what attendees  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

Offered to
- (Bio)pharmaceutical and Medical Device companies as in house seminars
- Contract laboratories as in-house seminars
- Seminar and Conference Providers to organize public workshops

  •  All in one: theory - practice - tool kits for easy implementation
  • Learn about theory and strategies from the FDA compliance expert
  • Practice through through case studies, interactive discussions and examples
  • Use the up to 30 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 offered in two dedicated areas

  1. Validation and compliance of general computer systems and electronic records
  2. Compliance in quality control and contract laboratories

We differentiate our courses from other suppliers in several areas

  1. A lot of practical work, ranging from going through examples and case studies to collaborative workshops built into each training module.
  2. Extensive hand-outs that not only include electronic copies of the slides but also up to 30 best practical documents such as SOPs, case studies, validation examples, checklists and master plans.
  3. All courses are developed by Dr. Ludwig Huber, the world expert in Laboratory compliance, computer validation and electronic records compliance.

The theme of all courses is: Put theory in practice through interactive discussions, 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.

Workshop Titles - Compliance for General Computer Systems

Workshop Titles - Compliance for Laboratories and Systems

Preparation and Organization

Workshops are

  • Prepared and delivered by Labcompliance
  • Organized as in-house seminar by end-user firms or by conference providers
  • Organized as public seminars through seminar or workshop providers

Costs

Client (organizing company) pays

  • Presenter fee: $2000 net / seminar day
    (includes course development and preparation of one set of course material)
  • Fee for presenter's traveling time: $1000 net/traveling day
  • All presenter's travel expenses

Terms of Payment

Advanced payment 

Location

  • On demand, anywhere in the world
  • Exact locations will be defined by organizing company - in house or public

Dates

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

Click here to tell others in your company about these workshops

What attendees get

  • Workshop conducted by an internationally recognized compliance expert
  • Industry proven real-life case studies
  • Highly efficient workshop exercises through prefilled templates
  • Answers to any issues directly by the trainer in an one-on-one interaction
  • Take home SOPs, templates and examples for cost effective implementation
  • Access to the PowerPoint presentations to train others in your company
  • 30 days phone and e-mail post workshop support through the trainer
  • Certificate of training completion
  • Detailed documentation of the trainer's qualification

More info?

If you are interested in any of the Labcompliance In-house workshops or in organizing a public workshop please use the contact form below.

If you have any specific question, please contact us at +49 7802 980 582 or through e-mail.

   

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(I am aware that our company will be responsible for organizing the event and  Labcompliance will prepare the course material and deliver the course)
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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 Systems
  • Presenter of the Year of the Institute for Validation and Technology selected out of 170 presenters
  • Author of the books ‚ÄúValidation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
  • Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues.
  • For more information on Ludwig Huber, click here.
Dr. Ludwig Huber is a frequent presenter at  conferences and has been awarded as IVT's 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.