The document describes an upcoming webinar on efficient and effective FDA and ISO management reviews. The webinar will be led by Betty Lane, who has over 30 years of experience in medical device quality assurance and regulatory affairs. She will discuss how companies can make management reviews fit their needs and get senior management involvement, covering requirements and effective approaches. Attendees will learn how to engage management and efficiently conduct and document reviews.

1. Efficient and Effective FDA and ISO
Management Reviews
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

2. 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

3. Description:
The Webinar will discuss how to make your Management review fit your company and
the best ways to get involvement from your senior management. This presentation will cover
the requirement for management review from FDA cGMP and ISO 13485 and approaches
that can make these effective. Management review should be a key part of keeping your
quality management system efficient and effective. It will cover how to get the attention of
your senior management as well as practical advice on efficient methods for conducting and
documenting management reviews.
Why Should you Attend:
Are your management reviews effective or do you have trouble getting senior
management engaged? Perhaps you are not using an effective approach that fits
your company or your management. It is not only important to know what must
be covered, but how to present this information to your management team. Learn
how to get management's attention to the information being presented and how
to make it fit your company culture. Obtain practical information on conducting
and documenting management reviews.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

4. 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

5. Reach us on :
www.onlinecompliancepanel.com
Our
links
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com