Preparing for and Managing Regulatory Inspections

Onsite Training & Consulting
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Course Description

Are you ready for your next regulatory inspection? Do you know what to do before, during, and after an initial or follow-up inspection?

Don’t be caught off guard! The key to effective management of regulatory inspections is preparation. This program was developed to help participants determine how to build a robust system for handling regulatory inspection and ensuring that all employees follow the process. Discussions center on FDA’s Quality System Inspection Technique (QSIT) and how to set up a system to best prepare for successful FDA regulatory inspections of your organization.

Preparation for a regulatory inspection is just the beginning of the inspection management process. It is critical that everyone knows what to do when an inspector visits your facility, how to handle the inspection process, and what actions to take after the inspector leaves the premises. This program covers how your company can design a system to prepare for a regulatory inspection, including proper behavior of staff during the audit, as well as the follow-up process and response to possible 483 observations.


CEUs:1.5
Number of days:2
Code:FDP
Cost:$1495.00

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Objectives
  • Understand the scope of FDA’s authority and expectations.
  • Understand FDA’s enforcement actions.
  • Explain the purpose, benefits, and objectives of FDA’s QSIT.
  • Define the types of FDA inspections.
  • Describe the steps of FDA’s regulatory inspection process.
  • Understand the scope and methodology of international regulators.
  • Design a training system to effectively prepare for and manage FDA’s inspection.
  • Understand every employee’s responsibilities and potential role during an inspection.
  • Create an effective follow-up process after the inspection, including response to 483s and warning letters.
Topics
  • Types of regulatory inspections
  • FDA’s QSIT approach to regulatory inspections
  • FDA’s investigations operations manual
  • Do’s and don’ts of regulatory inspections
  • Responding to audit observations following an inspection
  • Comparing FDA and international inspections
  • Discussion of recent 483 inspectional observations and warning letters
Who Should Attend

This course was designed for managers, professionals, technicians, and supervisors in the following departments: QA, QC, production, maintenance, training, HR, validation, purchasing, IT, and others.

Upcoming dates and locations
Please contact us if you need additional information or if you don't see a date that works for you.
To register by phone, call 800.472.6477

Search by Date and/or Location
 
 
 
 
Course Name On-Site Public Dates
Location Start Date Days Cost Registration
Preparing for and Managing Regulatory Inspections CONTACT US San Juan, PR 06/27/2012 2 $1495.00 Add to Cart
Preparing for and Managing Regulatory Inspections CONTACT US Chicago, IL 08/01/2012 2 $1495.00 Add to Cart
Preparing for and Managing Regulatory Inspections CONTACT US Princeton, NJ 08/22/2012 2 $1495.00 Add to Cart
Preparing for and Managing Regulatory Inspections CONTACT US San Francisco, CA 09/12/2012 2 $1495.00 Add to Cart
 
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