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Training of employees is required under the FDA Good Manufacturing Regulations (cGMP). It is also a major component of the employee competence now required under ISO 13485:2016. Making sure you comply with these requirements might seem easy, but documenting and tracking all types of training for all employees, is not always easy. Making sure that your system for meeting these requirements meets all the current requirements is essential to maintain compliance of your Quality Management System
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.
Description of the topic:
FDA training and ISO 13485 Training requirements will be presented. How training fits into the ISO 13485:2016 requirements for assuring that all employees are competent will be addressed and compliance approaches discussed. 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 the 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
Areas Covered in the Session :
Who will benefit:
· Quality Management
· Human resource managers
· Quality Specialists
· Training supervisors
· Production supervisors
· Quality specialists
· Quality Associates
· Operations and Manufacturing Managers
Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada. Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP.