Webinar On Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs
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Category Medical Devices
Deadline: April 28, 2015 | Date: April 28, 2015
Venue/Country: Mississauga, Canada
Updated: 2015-04-13 22:08:10 (GMT+9)
Call For Papers - CFP
Description : The US Food and Drug Administration (FDA) states in warning letters “this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…” This webinar will address the said current good manufacturing practice (cGMP) requirements to help you stay in conformity with 21 CFR Part 820 (QSR).Accurate understanding and interpretation of cGMP requirements found at 21 CFR Part 820 can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the market faster.This webinar is intended to help you get familiar with FDA’s Quality System Regulations (cGMP) for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the best practices for implementing 21 CFR Part 820 (QSRs), which helps assure that medical devices are safe and effective for their intended use. This 60-min webinar will help you ensure if you engage in the best practices for establishing and maintaining quality management systems necessary to achieve compliance and to remain compliant with 21 CFR Part 820 (cGMPs).Areas Covered in the Session :Applicable LawsFDA Quality System RegulationsDefinitionsDesign Control: Design And Development Planning, Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, And Design ChangesDesign History File (DHF)Quality System Procedures, Purchasing Controls And ServicingInspection, Measuring And Test EquipmentProcess ValidationCorrective And Preventive Action (CAPA) And Complaint FilesQuality Requirements For Premarket Approval (PMA) ApplicationDevice History Record (DHR) And Device Master Record (DMR)Mistakes While Implementing QSRsHow to Avoid MistakesFrequent Citations in 483s and How to AvoidTop 20 Items Cited in 483sLessons Learned: Best PracticesWho Will Benefit:CEOsVPsCompliance OfficersAttorneysR&D and Manufacturing ManagersManagers (RA, QA/QC, CA)ConsultantsContractors and SubcontractorsPrice tags:LiveSingle Live : For One Participant$ 189Corporate Live : For Max. 10 Participants$ 699RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 239For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada Customer Support : #416-915-4458 Email : supportcompliancetrainings.comFor more information about this event please visithttps://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1513Like Us On facebook:https://www.facebook.com/events/1413859228918769/
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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