This Medical device training will instruct on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training. 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).
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).
Areas Covered in this seminar:
- Regulatory requirements of personnel training
- Establishment of a training program, including new employee training
- Methods of training
- The importance of the legal manufacturer and understanding what this is
- How to document training for making it readily available for review
- When to evaluate training requirements, training effectiveness, and when training is not required
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
- Consultants
Course Provider
Jeff Kasoff,
