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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On-line Audio Seminar 285

FDA/EU Compliant Training for Laboratory Personnel

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

Recorded, available with all reference material at any time

Laboratory personnel should be qualified to perform the assigned task. This is very logical; it is easy to say but difficult to achieve and maintain. No or inadequate training of laboratory staff is one of most frequently cited deviations in FDA warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. 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 laboratory 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 laboratory training requirements in US and EU
• Most frequently cited deviations in FDA warning letters and how to avoid them
• Developing an effective laboratory training program for a company or site
• 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 to prove effectiveness
• Documentation of trainings for the FDA and other agencies
• Specific training requirements for FDA Part 11 and EU Annex 11

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

• Slides as PowerPoint Presentation
• Script
• Q&As from before, during and after the seminar
• 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 requirements and gap analysis, attendance of trainings, training summary for the US FDA and EU
• 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

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

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.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
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.-

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 author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, 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'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,