How do you use FDA Guidance Documents and Recognized Standards – Perspective of a Consultant?
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Speaker : ELISABETH GEORGE
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When : Thursday, October 03, 2024
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Time : 01 : 00 PM EST
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Elisabeth is an experienced leader, business executive and consultant committed to shaping and leading global organizations in continuous improvement and innovative ways of using standards and regulations not only for compliance but also for supporting customer value. She frequently speaks at Industry and Standards Conferences where stakeholders from Regulators, Industry and Users (Clinicians and Patients) participate. She is a recent recipient of the NEMA Röntgen Award and the ANSI George S. Wham Leadership Medal recognizing her leadership and drive. She is committed to making an impact through her skills as a leader, her experience in Medical Device Regulations and Standards and her desire to be a learning partner in delivering positive business outcomes. She is presently serving on the ANSI Board of Directors. Appointed as to Global Expert Advisory Group to Korea Ministry of Food & Drug Safety.
Known as a transformational leader, her track record of setting clear strategies, driven by rigorous engagement across the total product life cycle including customer insights have permitted her to be able to focus on the big picture while also being able to have hands-on experience.
Elisabeth’s broad perspectives and drive for high-performance, whether during an aggressive innovative growth strategy session or a compliance turnaround, is her commitment to organizational culture with purpose at the core. Her versatile extensive experience working across the organization allows her to identify and integrate her diverse skills and technical competencies across all geographies into a unified, agile and empowered workforce. She understands the business and personnel challenges while helping to drive team collaborations and innovations.
Elisabeth has held senior leadership roles for more than 30 years, joining Haemonetics in 1989 as a Director of Quality and Regulatory to Sr. Director and Vice President of Quality and Regulatory positions with Hewlett Packard, Agilent and Philips.
At Philips she held the positions of Vice President of Quality, Regulatory, Sustainability and Product Security responsibility for two of the major product lines – initially the Patient Monitoring Businesses and then for the Imaging Systems Businesses. Also while at Philips she held the position of Vice President/Head of Global Regulations and Standards representing Philips in trade associations, regulatory body advisory panels and standards development organizations including to name a few: AdvaMed, AAMI, ANSI, NEMA, IMDRF, and FDA Advisory Panels.
Elisabeth holds a Bachelor’s in Science, Biomedical Engineering from Boston University and a Masters Certificate in Engineering Management from Northeastern University.
In addition, Elisabeth is serving on several Boards both professional (ANSI)as well as City Government including Vice President of Central Beach Alliance Board, Board Member of the Marine Advisory Board and Vice President, Secretary and Governance Committee Chair of Suits Stilettos & Lipstick Board of Fort Lauderdale.
In her spare time, Elisabeth enjoys spending time with her family, traveling, boating, scuba diving and loves to try new food while paring it with good wines.
Examples of Present Consulting Work:
- Global Regulatory Strategy – Across complete TPLC including Standards Strategy and Clinical Support including pre-submission meeting support.
- Quality System Improvement – Process development to support business strategy and compliance.
- Audit Work – Preparation, Execution and 3rd Party Support for Pre-submission, ISO 13485 and FDA QSR as well as general support for ISO14001 and ISO 28001.
- CAPA and Compliant Review and Support including risk management and post market surveillance and field action activities.
- Training Support – Developing and presenting.
This event will help you to learn about the FDA’s Guidance Documents and their recognition of standards. The FDA is the regulator for medical devices, and they want to ensure products are safe and effective. An optimal way of doing so is through the use of standards. Standards are developed by a cross-section of personnel from clinical and technical areas. The FDA is one of those stakeholders which allows them to understand the standards content and how to use them in designing and testing of products and solutions. The FDA utilizes international and national standards. This event will give you the basics behind how the FDA is involved and how they recognize these standards as a part of their guidance documents directly. It will also support awareness of how to use their databases which will support getting your products to market in a timely and effective manner.
Areas Covered
- Who are the Stakeholders and what is their role?
- What is the value as well as the challenges in utilizing guidance documents and international standards?
- How does the FDA use standards to support compliance and conformity assessment of your solutions?
Who Should Attend
Medical Device: Regulatory and other functions support the development of medical devices.
Why Should You Attend
As regulations get more complex and technologies are changing at a rapid rate, it’s important to find ways to support all stakeholders to medical devices by getting your products to market quickly in a safe and effective manner. The FDA has guidance documents and recognizes international standards allowing its stakeholders a level of transparency in requirements.
Topic Background
Opportunity to learn the perspective of how the FDA uses Guidance Documents and Standards in support of medical device regulatory compliance.
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$199.00
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