The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control.

Many times, the arrival of a Regulatory Investigator is a daunting experience for some.  This webinar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol for setting up the Inspection room and any associated “war” rooms that will support the inspection, and how to manage requests from the investigators in a timely and accurate manner.  This preparation minimizes stress and disorder during the inspections.

Who Should Attend:

Quality Control Personnel & Management

  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management
  

Learning Objectives:

Upon completion of this session, attendees will:

·         Learn Pre-planning and preparation activities

·         Know What to do when the investigator arrives

·         Know What documents to have ready and on hand

·         Develop Assignments and responsibilities for the inspection

·         Be Aware of  Inspection Do's and Don'ts

Course Outline:

Module 1:

FDA Inspections 101

I. Unannounced FDA visits – how to prepare and react

ii    Preparing for FDA audits / PAI preparation – what training should look like for key players

iii  Basic concepts that should be employed by everyone regulated by the FDA – review of quarterly quality topics to keep current

Module 2:

Company Preparedness

I    How a company can prepare for situations like this – training of SMEs and beyond

ii    How a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business

Module 3:

Observations and Lessons Learned

I     How should a company respond to 483 observations or a warning letter – deadlines, tracking, and closures

ii     Lesson learned – reviews of the observations and overall inspection experience

Module 4:

Real-Life Situations

I      Case Scenarios – review of real life scenarios that you could encounter during inspections