A Comprehensive View of FDA Regulations for Medical Devices
Website https://www.complianceonline.com/fda-regulations-for-medical-devices-seminar-training-80118SEM-prdsm |
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Deadline: February 24, 2020 | Date: March 05, 2020-March 06, 2020
Venue/Country: San Diego, CA, U.S.A
Updated: 2020-01-02 23:35:19 (GMT+9)
Call For Papers - CFP
Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.”This two day interactive course on FDA regulations for medical devices will:Cover more than just the Quality Management SystemProvide an overview of regulations and how they fit togetherExplain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementationHelp attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standardsTeach the current device marketing regulationsDiscuss how to handle FDA inspections and effectively respond to inspectional observations and 483sKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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