Medical Device Employee Training

Overview:

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, can be a real challenge. This is especially true for start-up and other small medical device companies, or rapidly growing companies. Specific FDA training requirements will be presented. Techniques for needs assessment and record keeping will focus on in-house training while also covering how experience and outside training can be integrated into this training. Although this presentation will focus on what works for small and medium sized companies, the principles are equally applicable to larger companies.

In this presentation will cover the requirement for training for FDA cGMP and ISO 13485 and approaches that can make this training effective. Included will be best practices for planning, setting an agenda, notifying attendees, as well as what and how to document your training. The Webinar will discuss how to make your training fit your company needs and size, including covering a variety of ways training can be documented and tracked.

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. These can be costly, and potentially even a safety risk to users of your product, themselves or other employees. Most medical device companies are aware of this, and 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 and to assure regulators that they are.

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
• Provide examples of simple spreadsheets that can be used to track training needs and records in one file.These are ideal for small and medium sized companies
• Overview of types of solutions that can be applied to larger medical device companies
• Description of specific techniques for monitoring and documenting training effectiveness
• Review of types of training requirements from the FDA and ISO 13485
• Providing examples of ways to document training needs for employees

Who Will Benefit:

• Quality Management
• Human resource managers
• Quality Specialists
• Production Supervisors
• Training Supervisors
• Quality Specialists
• Quality Associates
• Operations and Manufacturing Managers

Speaker Profile

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 for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Others Details

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