In this training you will learn what are the FDA requirements for training, how to develop an effective training program, training plan for individual employees, documentation, assessment, training tools available and specific training requirements for GXP and part 11.
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 seminar will give a good understanding of FDA requirements for training and provide recommendations for implementation.
Areas Covered in the Seminar:
- 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.
Hand-outs:
For easy implementation, attendees will receive
- Primer: Successful compliance training (20 pages)
- SOP: Training for GMP Compliance
- SOP: Training for GxP, 21 CFR Part 11 and Computer Validation
Who Will Benefit:
- Pharmaceutical and medical device industry
- Manufacturers of pharmaceutical ingredients
- Training departments
- A managers and personnel
- Analysts and lab managers
- Validation specialists
- Regulatory affairs
- Human resources (HR) managers and staff
- Documentation department
- Consultants
Instructor Profile:
Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at 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. For more information, visit Dr. Huber’s website:
www.ludwig-huber.com .
