Live webcast What Firms Should Do to Best Prepare for and Manage Audits by EU Notified Body and FDA
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Website https://compliance2go.com/product/?pid=CP2014-430 |
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Category Biotechnology;Medical Device;Pharmaceutical
Deadline: March 30, 2015 | Date: March 31, 2015
Venue/Country: Online, U.S.A
Updated: 2015-03-03 17:16:48 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThis webinar is intended to help you get familiar with regulatory audits by the US Food and Drug Administration and EU Notified Bodies.This webinar is further intended to help you understand what you can do to best prepare for and manage the audits by EU Notified Bodies and FDA with increased awareness.The FDA enforcement actions have recently increased. In EU, EU commission issued recommendation concerning unannounced audits by notified bodies in medical device industry.As a medical device firm, you are subject to regulatory audits or inspection by the US FDA and EU notified body if you bring your medical device products into the US and EU countries allowing CE-marked products. This webinar will cover the details of how you can proactively prepare for and manage the audits. Why Should you AttendTo learn how to adequately prepare for and manage regulatory audits by the US FDA and EU notified bodies. Areas Covered in the WebinarStatutes and Regulations in US and EUDefinitionsEU Unannounced AuditsComparative Overview of both ISO 13485 and 21 CFR Part 820Understanding Auditing StrategyAudit Objectives and ProcessHow to Audit Quality Management SystemsVarious Audit ApproachesQuality Systems and Subsystems in ISO 13485Quality Systems and Subsystems under 21 CFR Part 820FDA and ISO 13485Communication during Audit or Inspection: Dos and Don’tsGood Practices: Speaker’s Suggestions and RecommendationsConclusionWho will BenefitRegulatory AffairsQuality ProfessionalsR&D Complaint And Risk Management PersonnelConsultantsContractors/SubcontractorsCEOsVPsClinical AffairsOther Interested PartiesWebinar Includes:Q/A Session with the Expert to ask your questionCopy of PowerPoint slides (PDF print only)60 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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