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Current Good Manufacturing Practice for Medical Devices Including IVDs


Tuesday, November 27, 2012
Online Training
Wilmington, United States

http://bit.ly/RAExXW

Event Type: Conference

Overview: This webinar is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the cGMP requirements set out in the Quality System Regulations (QSRs), which help assure that medical devices are safe and effective for their intended use. 

Areas Covered in the Session:

 

  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Overview and review of the US QSRs for medical devices
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Flexibility of the QSRs
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Definitions
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Quality system requirements
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Management responsibility
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Audits
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Personnel
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Design control

Who Will Benefit: 

  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">CEOs
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">VPs
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Compliance officers
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Attorneys
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Clinical affairs
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Regulatory affairs
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">Quality assurance
  • http://www.globalcompliancepanel.com/images/compliance/arrow1.gif); background-position: 0% 0%; background-repeat: no-repeat no-repeat;">R&D
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