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.
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
A managers and personnel
Analysts and lab managers
Human resources (HR) managers and staff
Note: These complimentary hand-outs will be sent to customers on request. Please email firstname.lastname@example.org for these documents, stating your order number, and they will be emailed to you within 4 working days.
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.
Ludwig Huber , Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor o Lab Compliance, 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 .
Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness- Webinar
Product Type : On Demand Webinar
Author : Dr. Ludwig Huber
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