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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 is 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.
This webinar will give a good understanding of FDA requirements for training and provide recommendations for implementation.
Reference material for easy implementation:
Primer: Successful compliance training (20 pages)
SOP: Training for GMP Compliance
SOP: Training for GxP, 21 CFR Part 11 and Computer Validation
Areas Covered in the Session:
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
Who Will Benefit:
QA managers and personnel
Analysts and lab managers
Human resources (HR) managers and staff
Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/Effective_Training_Practices