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:
- Training departments
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Regulatory affairs
- Human resources (HR) managers and staff
- Documentation department
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
Don't wait to register for the Webinar on Effective Training Practices for FDA Compliance. You'll meet influential people and maximize your opportunities for success. Start now by accessing the information below.
|Conference/Event Dates:||04/13/2016 - 04/13/2016|
|Conference/Event Hours:||75 Minutes|
|Primary Industry:||Clinical Pharmacology|
|Other Industries:||Business, Clinical Pharmacology, Food / Beverage, Pharmaceutical, Professional Healthcare|
QA managers and personnel
Analysts and lab managers
Human resources (HR) managers and staff
|Number of Exhibitors:||1|
|Booth Size||Booth Cost||Available Amenities|
|Marketing Vehicles Allowed:||n/a|
|Other Booth Sizes Available: n/a|
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