Effective Regulatory Inspections
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Deadline: May 17, 2016 | Date: May 17, 2016
Venue/Country: Online, U.S.A
Updated: 2016-05-06 14:59:22 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThe purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control.Many times, the arrival of a Regulatory Investigator is a daunting experience for some. This webinar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol for setting up the Inspection room and any associated “war” rooms that will support the inspection, and how to manage requests from the investigators in a timely and accurate manner. This preparation minimizes stress and disorder during the inspections.Why You Should Attend:To learn the how to set up support groups/rooms for the inspection. Learn how to properly communicate with the inspectorTo be able to organize requests from the inspectors and process them in a timely and accurate manner.Know what is expected of you and your companyLearn what not to say or do during an inspection. To learn how to use your internal Quality Assurance groups to help identify issues prior to an inspection. Areas Covered in the Seminar:Pre-planning and preparation activitiesWhat to do when the investigator arrivesWhat documents to have ready and on handAssignments and responsibilities for the inspection A review of Inspection Do's and Don'tsThe Opening and Close-out Sessions Who Will Benefit:Site Quality Operations ManagersQuality Assurance personnelPlant Managers and SupervisorsManufacturing Superintendents and ManagersIndividuals whose job knowledge and/or expertise may be called upon during an auditRegulatory Affairs ManagersLearning Objectives:Upon completion of this session, attendees will learn the proper way to set up for a Regulatory Inspection, ensuring the inspection flows smoothly throughout the duration, and the proper way to speak to inspectors while they are performing the audit.Webinar includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides60 Minutes Live PresentationCertificate of attendance
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