Webinar On Laboratory Developed Tests
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| 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 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 For more information about this event please visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1552 |
| URL: | https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1552 |
| Date: | Monday, June 15, 2015 |
| Time: | 5:00pm-6:00pm UTC |
| Duration: | 1 hour |
| Access: | Public |
| Category: | Webinar* |
| Created by: | Public Access |
| Updated: | Wednesday, May 27, 2015 6:15am UTC |
| : | $249 |
| : | 4169154458 |
| : | suzzane.d@compliancetrainings.com |
| : | Compliance Trainings |
| : | 4169154458 |
| Comments: | None |