Efficient and Effective FDA and ISO Management Reviews - PowerPoint PPT Presentation

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Efficient and Effective FDA and ISO Management Reviews

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This webinar will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. – PowerPoint PPT presentation

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Title: Efficient and Effective FDA and ISO Management Reviews


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

www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com
4
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_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
6
About 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
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