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
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