FDA training and ISO 13485 Training requirements will be presented. We will cover techniques for needs assessment and record keeping particularly focused on in-house training while also covering how general training, employee experience and outside training can be integrated into and employees’’ training records. Most medical device companies are generally good at specific job-related training, although often not good at documenting this training. From a regulatory perspective, training must be documented. From a company perspective, without properly assessing training needs, documenting actual training and making sure that training is effective, you may not be able to adequately assess if employees are properly trained and to assure regulators that they are. 

This webinar will provide valuable assistance in: 

• Understanding FDA and ISO training requirements
• Understanding how to manage an effective training process
• Developing and documenting employee training needs
• Techniques for tracking training for all sized companies
• Understanding training effectiveness and ways to document it

This presentation will provide information and tips on best practices for assuring your employees are properly trained and you can demonstrate it. Training is required by the FDA and ISO 13485, but determining employee competence, including training needs and tracking of all employee training can be challenging, especially as companies grow. No one disputes the importance of proper training for all employees in a medical device company. Yet defining needs for all employees, either individually or by position description, is not always easy. This is especially true for start-up and other small medical device companies. Improperly or inadequately trained employees lead to both product and process nonconformities. These can be costly, and potentially even a safety risk to users of your product, themselves or other employees.