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Webinar On FDA Inspections

Managing the Myth and the Reality

Description :When FDA shows up at your front door to announce an inspection, what do you think is going to happen?  More importantly, what are you going do?An ex-FDA investigator will conduct this webinar to share an “insider’s” perspective about inspections. You may find answers to the question, “What is he thinking?” when the investigator starts digging through the complaint files or starts reading memos on lunch room bulletin board.Firms with an established FDA inspection protocol typically understand what happens during an inspection and why an inspection should be managed carefully. Many firms do not understand FDA inspections or may not have given them serious thought. That type of firm seemingly plans in a panic. Areas Covered in the Session :FDA’s overall inspectional programFDA inspection preparationFDA regulatory Compliance ProgramsInvestigations Operations ManualInspectional techniquesWho Will Benefit:Note: All of the following areas are subject to FDA inspectional coverageSenior Executives who are ultimately responsible for the firmIn-house legal counselSenior managers for OperationsSenior managers for MarketingRegulatory Affairs ManagersQuality Assurance ManagersManufacturing and Design ManagersRisk managersFDA consultants


19 Jan 2016 @ 01:00 pm

19 Jan 2016 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar



Organised by

Compliance Trainings (deactivated)

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