2012 - FDA/EU Compliant Training for Laboratory Personnel

This seminar will discuss strategies and present examples on what to train, how much to train and how to document effectiveness
Why to attend:
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.
Areas Covered in the Seminar:
* 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 for the FDA and other agencies
* Specific training requirements for FDA Part 11 and EU Annex 11
Date: February 16,2012
Time: 11.00 - 12.00 a.m. EST
Location: Online, worldwide
Who should attend
* Training departments
* QA managers and personnel
* Analysts and lab managersV
* alidation specialists
* Regulatory affairs
* Human resources (HR) managers and staff
* Documentation department
* Consultants
Weblink: http://www.labcompliance.com/seminars/audio/285/de...
Presenter: Dr. Ludwig Huber
Category: Pharmaceutical, FDA, validation