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Medical Device IVD Regulations Training - Live Webinars, Recordings & CDs

Recorded/CD
How to Prepare for the New EU Medical Device Regulations

How to Prepare for the New EU Medical Device Regulations

  • Speaker: Richard Young
  • Product ID: 705513
  • Duration: 90 Min
The course is designed to review critical elements of the new regulations and will be run as an interactive 2 hour course designed for business leaders with a good working knowledge of current requirements.
CD/Recorded
$279
Recorded/CD
FDA Inspections: What Regulations Expect

FDA Inspections: What Regulations Expect

  • Speaker: Joy McElroy
  • Product ID: 705346
  • Duration: 90 Min
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.
CD/Recorded
$249
Recorded/CD
FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products

FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products

  • Speaker: Dev Raheja
  • Product ID: 703898
  • Duration: 60 Min
This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.
CD/Recorded
$25
Recorded/CD
LDT including CDx; CLIA versus FDA's Authority

LDT including CDx; CLIA versus FDA's Authority

  • Speaker: Abdel Halim
  • Product ID: 703399
  • Duration: 60 Min
This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.
CD/Recorded
$229
Recorded/CD
cGMPs for Medical Devices, Including In Vitro Diagnostic Devices

cGMPs for Medical Devices, Including In Vitro Diagnostic Devices

  • Speaker: David Lim
  • Product ID: 702349
  • Duration: 90 Min
This 90-minute webinar will discuss the current good manufacturing practices (cGMPs) for medical devices and in vitro diagnostic devices.
CD/Recorded
$229
Recorded/CD
Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH

Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH

  • Speaker: Alfredo J Quattrone
  • Product ID: 700442
  • Duration: 60 Min
This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.
CD/Recorded
$149
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