The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control.
However, the arrival of an investigator for an inspection can still be an intimidating experience. The inspection can be less traumatic if the site and its personnel are properly prepared for the inspection and the investigator. During this hour presentation, you will find out how to prepare for the inspection and minimize stress, disorder, and any misinterpretation by the investigator during the inspection with careful planning of activities and effective resource development will support a successful inspection.
Why you should attend:
* Recognize the purpose of the inspection
* Learn how to properly communicate with the inspector
* Anticipate what information the investigator can and will request
* Know how to keep the inspection from being an “emotional” event.
* Know what is expected of you and your company
* Learn what not to say or do during an inspection.
* Recognize your audit responsibilities and vulnerabilities
* Identify the internal support system of a successful inspection
* Realize what steps you/your company should take to prepare for a successful inspection
Areas Covered in the Session:
* Expectations of an audit
* Why the FDA conducts inspections
* Pre-planning and preparation activities
* What to do when the investigator arrives
* What documents to have ready and on hand
* Assignments and responsibilities for the inspection
* A review of Inspection Do's and Don'ts
* The Opening and Close-out Sessions
* Actions to take after the inspection is over
Who Will Benefit:
* Site Quality Operations Managers
* Quality Assurance personnel
* Plant Managers
* Manufacturing Superintendents and Managers
* Individuals whose job knowledge and/or expertise may be required during an audit (Subject Matter Experts)
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