FDA Medical Device Compliance and Enforcement: Lessons from Last Year and Your Game Plan for This Year Webinar, Feb. 27, 2019

New FDA proposals create new inspectional approaches. Experts explain how to keep up to date

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Feb 13, 2019, 00:00 ET

FALLS CHURCH, Va., Feb. 13, 2019 /PRNewswire-PRWeb/ -- FDA Medical Device Compliance and Enforcement
Lessons from Last Year and Your Game Plan for This Year
**An FDAnews Webinar**
Wednesday, Feb. 27, 2019, 1:30 p.m. - 3:00 p.m. EST
http://www.fdanews.com/fdamdcomplianceenforcement

New FDA proposals — including the pre-certification program and de novo regulation — create new inspectional approaches and risks for 2019.

Up to date with the latest thinking?

Bethany J. Hills, Chair, FDA Practice and Aaron Josephson, Senior Director — both of Mintz Levin — will provide a comprehensive understanding of compliance and enforcement trends and the contextual relationship of policy and regulation. Attendees learn about:

  •     What areas the FDA targeted in inspections in 2018 and has focused on for enforcement in 2019
  •     The nuances in compliance areas that create risk and should be closely monitored in quality systems
  •     The differences and revisions in inspectional programs affecting all medical device regulatory and quality professionals
  •     Enforcement tools the FDA will be using in 2019 to ensure compliance and evolving trends in how the FDA seeks enforcement
  •     The business implications of FDA enforcement trends and compliance policy through its new initiatives

Join on February 27 and keep up to date with the latest thinking on FDA medical device compliance and enforcement.

Meet Your Presenters:
Bethany J. Hills, MPH, J.D., Chair, FDA Practice, Mintz Levin
Bethany is Chair of the firm's FDA practice and leverages deep FDA regulatory experience and exceptional knowledge of the health care delivery system to help international and domestic health technology companies enter and navigate the US health care market. Bethany helps companies manage the full range of FDA regulation issues, from inspections and investigations through complex regulatory challenges affecting everything from product approvals and product labeling to collaborative research, supply, and distribution agreements. She focuses on mission critical strategic engagements, including all aspects of FDA communications.

Aaron Josephson, Senior Director, Mintz Levin
Prior to joining ML Strategies, Aaron spent 10 years with the US Food and Drug Administration, most recently as a senior policy advisor in the Center for Devices and Radiological Health where he led legislative policy development activities related to all aspects of medical device regulation and oversight. He also apprised members of Congress and their staffs about FDA policies and programs and advised multiple FDA Commissioners and other senior officials on strategy and content for meetings with Congress, industry representatives, and other stakeholders. In addition to negotiating the reauthorization of the medical device user fee program (MDUFA), Aaron led FDA's implementation of key provisions of the 21st Century Cures Act and the FDA Reauthorization Act.

Who Will Benefit:

  •     Quality and regulatory professionals
  •     Operational and management
  •     Executive and strategic
  •     Legal and compliance

Webinar Details:
FDA Medical Device Compliance and Enforcement
Lessons from Last Year and Your Game Plan for This Year
**An FDAnews Webinar**
Wednesday, Feb. 27, 2019, 1:30 p.m. - 3:00 p.m. EST
http://www.fdanews.com/fdamdcomplianceenforcement

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/fdamdcomplianceenforcement
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

SOURCE FDAnews