Webinar On Laboratory Developed Tests

Event Details

Time: June 15, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Ct
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: May 22, 2015

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Event Description

Description :

The webinar clarifies the regulatory concern that FDA has and whether subjecting Laboratory Developed Tests (LDTs) to FDA's device Quality System Regulation can make a measurable difference in the safety and effectiveness (reliability) of special IVDs. The arguments on both sides of the issue will be identified and how regulation may adversely impact the quality of health care we have today. The presumption by FDA is that regulation will improve these special IVDs and, thereby, improve the quality of health care.

You will learn how reporting regulations, such as FDA's manufacturing regulations (Quality System Regulation (21 CFR Part 820)), Medical Device Reporting (21 CFR Part 803) and Reports of Corrections and Removals (21 CFR Part 806) would apply to LDTs. Once you identified the regulatory obligations, the logistical issues will be discussed and the types of game plans that may be necessary.

Areas Covered in the Session :

Reasons for FDA regulation

Applicable regulations

Use and availability of LDTs

Identify logistical risks

Steps for implementation

Interactive Q&A Session

Who Will Benefit:

A must attend webinar for:

Clinical laboratories

Pathology practice groups

Medical institutions (hospitals) using Laboratory Developed Tests