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Webinar On Laboratory Developed Tests

 
  May 22, 2015  
     
 


Compliance Trainings, Online
2015-06-15


Description :

FDA has edged closer and closer to regulating IVDs developed in laboratories rather than by a typical manufacturer registered with the FDA. Public debate pits an initiative for imposing standardized regulatory controls against decades of using laboratory-developed tests by licensed clinicians. This brings to mind some very practical questions? How do physicians change the logistics of their practice? How can clinical institutions provide specialized care when their tools are taken away? FDA regulation hammers specialized medical practices by throwing the process into a regulatory mill. A test developed by the doctor would now require production by manufacturer, who is subject to layers and layers of regulatory controls. As a consequence, there is no useful or timely turn around for supplying special in vitro reagents. Can the doctor order, receive and use a special reagent the same day now?

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

Practitioners

Healthcare maintenance organizations

Medical device and diagnostic manufactures

Risk managers for healthcare practices

Regulatory affairs managers for IVD manufacturers

Cost control consultants for healthcare practices

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

 

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

 
 
Organized by: Compliance Trainings
Invited Speakers:

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.

 
Deadline for Abstracts: 2015-06-15
 
Registration:

For more information about this event please visit

 

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1552

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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