DUBLIN--(BUSINESS WIRE)--The "Managing Your FDA Inspection: Before, During and After" conference has been added to ResearchAndMarkets.com's offering.
The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection.
There should be no surprises if you have prepared properly. Firms need to understand the details about inspectional techniques to avoid making new problems for yourself during the inspection. You can save yourself a lot of corporate misery if you know what to do before, during and after an inspection.
FDA conducts inspections based on well established procedures. You can lower your anxiety level when you can predict what they will do during an inspection, what products they cover and how they will document your problems. Any type of regulated firm should the ground rules of an inspection to keep it under control. You should be able to see the hand writing on the wall if it looks bad and prepare accordingly. You should understand what is at stake based on the progress of an inspection.
How you respond to an investigator, to the inspection in general and to the FDA can seal your fate to an unhappy ending if you don't know what to do, how to do it and how fast you need to do it. Questions are encouraged. What did you want to know about FDA, but were always afraid to ask? What are the big mistakes firms make? Here the firsthand accounts of an ex-FDA investigator.
Learning Objectives
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FDA legal authority to inspect
- Over products
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Over firm's
- Scientific/clinical studies
- Premarket requirements
- Postmarket requirements
- FDA's annual inspection work plan
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Inspection Procedures
- FDA inspection Manuals
- FDA Training
- Documenting violations
- Refusals
- Human factors
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Recall procedures (What FDA expects from you)
- FDA Field Office Management
- FDA Center(s) Management
- The firm's job
- Inspectional observations (Form FDA-483)
- Responding to a 483
- Responding to a Warning Letter
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Recall procedures (What FDA expects from you)
- FDA Field Office Management
- FDA Center(s) Management
- The firm's job
- FDA enforcement actions
- Follow up inspections
- Foreign Inspections
For more information about this conference visit https://www.researchandmarkets.com/research/n8cvcb/2day_course?w=4
