FDA Inspections - Do's & Don'ts

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

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About the Author
Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, as well as internal and external public relations.