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Ref : 29051
Event :Medical Device Employee Training - Requirements and Implementation Tips

Date :Wednesday February 27th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


Further information


This webinar will review types of training requirements from the FDA and ISO 13485 for medical device employee. It will discuss techniques for monitoring and documenting training effectiveness.


  • 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


Betty Lane

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.


Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Medical Device Employee Training - Requirements and Implementation Tips Management
medical device training, quality training, training needs, training effectiveness, capa, cgmp, iso 13485, continuous improvement
Professionals, Quality Management Human Resource Managers Quality Specialists Training Supervisors Production Supervisors Quality Specialists Quality Associates Operations and Manufacturing Managers
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