Laboratory-Developed Tests - Medical devices 2017

What topics are covered by the course?

Definition of medical device, (21 USC 321(h))and how it has been interpreted by FDA and the courts
"Enforcement Discretion" and how it has been applied to LDT regulation
Extent of CLIA 88 authority over LDT performance
Role of US Congress in answering the question of FDA authority
International (EU) approach to LDTs

Who should attend?

QA Specialist
Complaint Coordinator
Regulatory Specialist
QA Manager
QA Trainer

What will I be able to do on completion?

Full Details & Registration Link:

How will I be assessed?

Netzealous LLC DBA - Compliance4All
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements.

Guide Price: $ 150

Delivery: Online
Category: Business & Management »
Duration: 60 Minutes
Qualification: N/A

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