Course Search

Find A Masters

1000's of Masters Courses from across the globe

Find An MBA

MBA & Business Masters courses from the World's leading Business Schools

Find A PhD

The World's largest PhD opportunities database

Course Details

Laboratory-Developed Tests - Medical devices 2017


Like this CPDs ?

Like This Course?


Extra CPD Information

More Info


Location of CPD provider

Institution Location


Related CPDs

Related Courses


Essential Medical Statistics (3) June 2021
University of Oxford
Department for Continuing Education

eCPD Small animal medical nursing online 2021
Royal Veterinary College
CPD Unit

Non-medical Prescribing for Health Care Professionals - Level 6
Birmingham City University
Faculty of Health, Education and Life Sciences

Compliance4all
Healthcare
Contact Provider
N/A
60 Minutes
Conference (Online)
-
-
£150.00
Regulatory Specialist, QA Manager, QA Trainer
Online / Distance Learning Course

Overview:
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests.

Why should you Attend:
This 1 hour session will explore the reasons FDA has for claiming such jurisdiction, and the objections to FDAs' position articulated by the clinical laboratory community, and others.

Areas Covered in the Session:
"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 Will Benefit:
QA Specialist
Complaint Coordinator
Regulatory Specialist
QA Manager
QA Trainer
All above in Medical Device companies

Speaker Profile:
Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]




Find CPD

Copyright ©2005-2021
All rights reserved

Find CPD is a database of Continuing Professional Development (CPD) Courses in the UK

FindCPD is a trading name of FindAUniversity Ltd.
FindAUniversity Ltd, 77 Sidney St, Sheffield, S1 4RG, UK. Tel: +44 (0)114 268 4940 Fax: +44 (0) 114 268 5766
Cookie Policy    X