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
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
10 Do’s and Don’ts for permanent success
Documentation of trainings for the FDA
Specific training requirements for Part 11
Who Will Benefit:
A must attend webinar for professionals in Pharmaceutical development and quality control companies, medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Clinical Research Organizations. The teams that will benefit the most are:
Quality Assurance Departments
Analysts and Lab Managers
Regulatory Affairs Departments
Human resources (HR) Departments