Preparing for FDA BIMO Inspection and Management
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Deadline: May 28, 2014 | Date: May 28, 2014
Venue/Country: 38868 Salmon Ter, Fremont, U.S.A
Updated: 2014-04-17 18:47:49 (GMT+9)
Call For Papers - CFP
Instructor: David LimDescription:This webinar is intended to help you get familiar with how to prepare for and manage an FDA BIMO inspection integrated with emotional intelligence (EQ)-based practical and actionable guidance so that a firm's preparation and readiness for an FDA BIMO inspection can be done in a more effective, less burdensome, and easily manageable manner at all levels of organization.This webinar will discuss what you need to be aware and become familiar with for your job to get done easier and in a less burdensome, straight-forward manner. The best practices for FDA BIMO inspection preparation and readiness purposes including a list of Dos and Don'ts before, during and after the inspection will be discussed. In addition, some key factors contributing to the overall efficiency and effectiveness of your FDA inspection readiness asnd management program will also be discussed.At the end of the webinar, you will be presented with ample information to drastically improve your current FDA inspection readiness program or equivalent with awareness and confidence. Objectives of the Presentation:Statutes and RegulationsDefinitionsFDA ManualsRegulatory Requirements for ComplianceFDA BIMO Inspection: Scope and DepthInspection Types and CategoriesInspection ClassificationInspection ProcessHosting an FDA InspectionHow to Answer QuestionsFDA Forms 482 and 483Dos and Don'ts Before, During and After FDA InspectionResponding to 483: Best PracticesMisconception and Frequent MistakesEnforcement CasesImproving AwarenessExercising Sound JudgmentGood Business and Employment PracticesTransparency, Accountability and IntegrityPractical, Actionable and Sustainable Recommendations: Best PracticesConclusionWho can Benefit:CEOsVPsCompliance OfficersAttorneysRegulatory AffairsClinical AffairsQuality AssuranceR & DConsultantsContractors/SubcontractorsAnyone Interested in the FDA (BIMO) Inspection Processhttp://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500301?expDate=Ourglocal
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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