Medical Device Employee Training - 2017
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.
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:
- Quality Management
- Human resource managers
- Quality Specialists
- Production Supervisors
Speaker and Presenter Information
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.
Relevant Government Agencies
Medical Device
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Wed, May 17, 2017, 10:00am - 11:00am
PT
Cost
General Admission: | $150.00 |
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All