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Labcompliance On-line Audio Seminar

On-line Audio Seminar 148

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)

Effective GxP Training Practices

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

Recorded

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No or inadequate training of employees is one of most frequently cited deviations in FDA inspection 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 is estimated that about 5% ofemployee'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?
  • 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.
  • Assessment of successful participation
  • The benefits of risk based training
  • Documentation of trainings for the FDA
  • Specific training requirements for 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 GxP, 21 CFR Part 11 and Computer Validation
  • SOP: Training of Laboratory Personnel
  • Checklist: Initial and On-going Trainings
  • Templates: Documentation of training plans, evaluation of trainings, training results for the US FDA and EU
  • SOP: FDA Inspections - Preparation, Conduct, Follow-up
  • Five 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.

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

How to order

Replaced by the more recent seminar

Effective GxP Training Practices

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

Click here

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 over the phone
  5. Ask questions through web forms

Attendees can discuss and ask questions over the phone, fax or e-mail.

The transcript and questions and answers have been be posted at the seminar website. This includes questions that came through e-mail and life during the seminar.

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.