FDA inspectional - Training Practices for FDA Compliance - 2017
Overview:
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.
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
Who Will Benefit:
Training Departments
QA Managers and Personnel
Analysts and Lab Managers
Validation Specialists
Regulatory Affairs
Speaker Profile:
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".
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
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.
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
Who Will Benefit:
Training Departments
QA Managers and Personnel
Analysts and Lab Managers
Validation Specialists
Regulatory Affairs
Speaker Profile:
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".
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
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