This is especially true for start-up and other small medical device companies, or rapidly growing companies. Specific FDA training requirements will be presented.
Why should you Attend:
This presentation will provide information and tips on best practices for assuring your employees are properly trained and you can demonstrate it. Improperly or inadequately trained employees lead to both product and process nonconformities.
Areas Covered in the Session:
Review of types of training requirements from the FDA and ISO 13485
Providing examples of ways to document training needs for employees
Looking at various ways to monitor the effectiveness of each type of training
Who Will Benefit:
Human resource 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.
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