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 regulationApplicable regulationsUse and availability of LDTsIdentify logistical risksSteps for implementationInteractive Q&A Session Who Will Benefit:A must attend webinar for:Clinical laboratoriesPathology practice groupsMedical institutions (hospitals) using Laboratory Developed TestsPractitionersHealthcare maintenance organizationsMedical device and diagnostic manufacturesRisk managers for healthcare practicesRegulatory affairs managers for IVD manufacturersCost control consultants for healthcare practicesPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458