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Webinar On FDA Inspections : Managing the Myth and the Reality

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?

FDA may inspect firms at a reasonable time, within reasonable limits and in a reasonable manner.  Whether or not an inspection appears reasonable depends on a person’s point of view. FDA investigators rely on well established procedures and techniques. In an FDA investigator’s mind, there really is no mystery about what happens during an inspection or why. The fact is though that many firms do not understand how an inspection is conducted and what follow-up regulatory action, if any, may be looming on the horizon.Why should you attend: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. How you manage an FDA inspection and the outcome of an inspection can have a material impact on the firm’s business, if not survival. The core direction of FDA inspections is to determine a firm’s level of compliance with FDA requirements and collect evidence to use against the firm for failing to comply with any regulatory requirement. The negative inspectional outcome can be costly in terms of money, lost business, consent decrees and the prosecution of the firm’s executives. Every FDA inspection concludes with a warning to that effect. 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 consultantsPrice Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458


18 Nov 2014 @ 01:00 pm

18 Nov 2014 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar



Organised by

Compliance Trainings (deactivated)

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