Medical Device Employee Training - Requirements and Implementation Tips

Duration: 60 Minutes
This presentation will provide information and tips on best practices for assuring your employees are properly trained. Improperly or inadequately trained employees lead to both product and process nonconformities.
iso 13485
Instructor: Betty Lane
Product ID: 500508

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. 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.

Why Should you Attend:
Inadequate training to medical devices employees could 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 trained and to assure regulators that they are.

Objectives of the Presentation:
This webinar will cover the following areas:
  • Review of the 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.
Who can Benefit:
This webinar will provide valuable assistance to all personnel in:
  • Quality Management
  • Human Resources professionals
  • Quality specialists
  • Trainers
  • Regulatory Affairs
  • Quality Engineers
  • Compliance managers
  • Quality auditors
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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Minimum 10 attendees
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor 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 quality system requirements for other area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs 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 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 (RPI), and an MBA from Northeastern University.
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