Title: Efficient and Effective FDA and ISO Management Reviews
1Efficient and Effective FDA and ISO Management
Reviews
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
2Instructor 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.Bettys 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_at_onlinecompliancepanel.com
3Description
- 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.
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4Why 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_at_onlinecompliancepanel.com
5- 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
QA 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_at_onlinecompliancepanel.com
6About OnlineCompliancePanel
- Online Compliance Panel creates
and delivers comprehensive industry relevant
training sessions. These sessions are simple,
interactive and cost effective. We are a
predominantly web based information exchange
forum. Live interactions on compliance training
make the process holistic and effective. Online
Compliance Panel largely emphasizes in offering
regulatory compliance training to compliance
professionals on varied topics. These primarily
include risk management, quality management,
corporate compliance and other regulatory
compliances. Some of our primary areas of focus
include advancement and updates in regulatory
compliance, best practices and market trends. -
- For the more information about the webinar
kindly visit the link given - http//bit.ly/contractmgnt
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com