Medical Device Employee Training - Requirements and Implementation Tips

Why Should You Attend:

Training is required by the FDA and ISO 13485, but determining training needs and tracking of training can be challenging, especially as companies grow. 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 being properly trained and to assure regulators that they are.

This webinar will present specific FDA training requirements. It will focus on techniques for needs assessment and keeping records of in-house training and will also cover how experience and outside training can be integrated into this training. It will provide information and tips on best practices for assuring your employees are properly trained and you can demonstrate it.

Learning Objectives:

• 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

Areas Covered in the Webinar:

• Types of training requirements from the FDA and ISO 13485
• Examples of ways to document training needs for employees
• Various ways to monitor the effectiveness of each type of training
• 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.
• Specific techniques for monitoring and documenting training effectiveness

Who Will Benefit:

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

Betty Lane
Founder and President, Be Quality Associates LLC

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 for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the RAPS, Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.

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