Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness
Instructor:
Dr. Ludwig Huber
Product ID: 700123
Training Level: Intermediate to Advanced
- Duration: 60 Min
Why Should You Attend:
No or inadequate training of employees is one of most frequently cited deviations in FDA inspection 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.
What Attendees will Learn:
- FDA training requirements
- 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.
- Developing an SOP for Trainings
- Assessment of effectiveness
- Documentation of trainings for the FDA
- Specific training requirements for part 11
Additional benefits:
Attendees will receive a checklist, an SOP and a 30+ pages primer on Trainings.
Note: These complimentary hand-outs will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.
Who Will Benefit:
- Training departments
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Regulatory affairs
- Human resources (HR) managers and staff
- Documentation department
- Consultants
Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems".For more information, visit Dr. Huber’s website: www.ludwig-huber.com
More Training By Experts
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