The FDA Inspection: Preparation, Management, and Follow-up
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Website https://compliance2go.com/product/?topic=the-fda-inspection-preparation-management-and-followup |
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Category Biotechnology , Medical Device , Pharmaceutical
Deadline: May 28, 2015 | Date: May 28, 2015
Venue/Country: Online, U.S.A
Updated: 2015-05-09 17:52:09 (GMT+9)
Call For Papers - CFP
DESCRIPTIONDoes the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.Areas Covered in the SessionHow to prepare for an FDA inspectionDevelopment and contents of an SOP for FDA inspectionPersonel training before inspectionHow to behave during an inspectionLimitations of scope of inspectionResponse to investigation findingsFDA guidance documents used by their inspectors.Who will benefit: (Titles)This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:Executive/senior managementRegulatory managementQA managementAny personnel who may have direct interaction with FDA officialsQuality system auditorsConsultantsWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides60 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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