To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them.
A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training so that it is readily available for review (by managers, auditors or inspectors), when to evaluate training requirements, training effectiveness, and when training is not required.
Why Should You Attend: On of the easiest ways to be cited for a major noncompliance during an ISO audit is to have an insufficient training system. Similarly, an FDA inspector will head right to your training records when sufficient nonconformances are discovered during an FDA inspection. Are ALL of your employees trained on ALL processes they perform?
Areas Covered in the Session: - Requirements for personnel training in QSR and ISO 13485
- Establishment of training program
- Methods of personnel training
- Documentation of training
- Evaluation of training requirements
- Verification of training effectiveness
- Instances in which training is NOT required
- On-the-job training
Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Human Resources management
- Regulatory management
- QA management
- Senior and mid-level management
- Consultants
- Quality system auditors
