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Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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For attendes of the seminar by Compliance Trainins on June 9, 2016

User ID: audio PW: am4921 (available until June 30, 2016

if expired contact:

On-line Audio Seminar 307

Efficient Training Practices for FDA and International Compliance

What to train - How much to Train - How to Document Effectiveness

Recorded, available with all reference material at any time

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No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.

Key Questions related to trainings are:

  • What do FDA and other regulations say about training?
  • What exactly are the expectations of inspectors?
  • How to develop an efficient and compliant training program?
  • What are the most efficient tools for GxP and Part 11 training?
  • How to develop and document training plans for employees?
  • Does risk based training make sense?
  • How to make training interesting?
  • How to motivate attendees for training on regulations
  • What documentation should be available as evidence for successful training: are certificates enough?
  • How should I document that the trainer was qualified?
  • Should electronic training tracking systems comply with 21 CFR Part 11?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like primers, SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • GxP training requirements in US and EU
  • Most frequently cited deviations
  • Developing an effective training program for a company, site or department.
  • Developing a training plan for individual employees
  • Who can or should be responsible for the training program and training plans.
  • Most efficient training tools for different tasks.
  • Writing the invitation for best attendance
  • Preparing the training material
  • Engaging the attendees for active participation
  • Adding examples and workshop exercises for enhanced retention
  • Special focus: Motivate attendees for training on regulations
  • Assessment of successful participation
  • The benefits of risk based training
  • 10 Dos and Dont's for permanent success
  • Documentation of trainings for the FDA
  • Specific training requirements for FDA Part 11

And for easy and instant implementation:
download 10+ documents from special seminar website

  • Primer: Successful compliance training
  • SOP: Training for GMP Compliance
  • SOP: Training for GLP Compliance
  • SOP: Training for GxP, 21 CFR Part 11 and Computer Validation
  • SOP: Training of Laboratory Personnel
  • Checklist: Initial and On-going Trainings
  • Five Case Studies: How to avoid and respond to training related 483s and Warning Letters: With root cause analysis, corrective actions and preventive actions
  • Templates: Documentation of training requirements and gap analysis, attendance of trainings, training summary for the US FDA and EU compliance
  • Ten Warning letters and Inspectional observations related to training.
  • 120 page primer on basics of GLP, GMP and equipment and computer validation. An excellent training tool for beginners.
  • Other publications.

For attendes of the seminar by Compliance Trainins on June 9, 2016

User ID: audio PW: am4921 (available until June 30, 2016

if expired contact:

The reference material includes five case studies related to TRAINIG with deviations, root cause analysis, corrective and preventive action plans, supporting documentation and a link to the full original 483 or warning letter.


Root cause

Who should attend?

  • Training departments
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Documentation department
  • Consultants

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars


Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and 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, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

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.

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 visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

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 explained FDA's next 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,