Effective Training Practices for FDA Compliance
Instructor:
Dr. Ludwig Huber
Product ID: 702513
- Duration: 75 Min
Why Should You Attend:
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 session will help you gain a good understanding of FDA requirements for training and provide recommendations for implementation.
Learning Objectives:
- 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:
Pharmaceutical development and quality control, API manufacturers, medical device development and manufacturers, contract laboratories and CROs will benefit from this training
- Training departments
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Regulatory affairs
- Human resources (HR) managers and staff
- Documentation department
- Consultants
Dr. Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.
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