Implementing the Best Practices for FDA Inspection Preparation and Management by compliance2go
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Website https://compliance2go.com/product/?pid=CP2014-440 |
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Category Biotechnology ;Medical Device ;Pharmaceutical
Deadline: April 29, 2015 | Date: April 30, 2015
Venue/Country: Online, U.S.A
Updated: 2015-03-26 21:00:29 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThis webinar is intended to help you get familiar with how to implement the best practices for FDA inspection preparation and management integrated with emotional intelligence (EQ) 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 and management program will also be discussed. At the end of the webinar, you can have a great opportunity to drastically improve your current FDA inspection preparation and readiness program or equivalent with awareness and confidence.Areas Covered in the Session: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 Awareness and Exercising Sound JudgmentGood Business and Employment PracticesTransparency, Accountability and IntegrityPractical, Actionable and Sustainable Recommendations: Best PracticesConclusionWho will benefit: (Titles)CEOsVPsCompliance OfficersAttorneysRegulatory AffairsClinical AffairsQuality Assurance R&DConsultantsContractors/SubcontractorsAnyone Interested in the FDA (BIMO) Inspection ProcessWebinar 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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