The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that your products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful inspection is being prepared to communicate how your quality systems assure this state of control.
What does a successful inspection look like? First, zero observations but that depends on your level preparedness and how you handle and manage the inspection. This includes such factors as: timely delivery of documents, good interview skills, your ability to demonstrate controlled systems and self-confidence. Do you have what is needed to have that successful inspection?
The arrival of an investigator for an unscheduled inspection can be an intimidating experience. However, 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,
Manage the activities of the inspection, the investigator and your inspection personnel,
Develop a system for an analysis of what happens after the inspection.
Why you should attend:
Recognize the purpose of the inspection
Anticipate what information the investigator can and will request
Learn how to properly communicate with the inspector
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 not do during an inspection
Recognize your inspection 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 and/or Compliance personnel
Plant Managers and Vice-Presidents of Quality
Manufacturing Superintendents and Managers
Individuals whose job knowledge and/or expertise may be required during an audit (Subject Matter Experts)
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
