Effective Regulatory Inspections

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Deadline: May 17, 2016 | Date: May 17, 2016

Venue/Country: Online, U.S.A

Updated: 2016-05-06 14:59:22 (GMT+9)

Call For Papers - CFP

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.

Why You Should Attend:

To learn the how to set up support groups/rooms for the inspection.

Learn how to properly communicate with the inspector

To be able to organize requests from the inspectors and process them in a timely and accurate manner.

Know what is expected of you and your company

Learn what not to say or do during an inspection.

To learn how to use your internal Quality Assurance groups to help identify issues prior to an inspection.

Areas Covered in the Seminar:

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

Who Will Benefit:

Site Quality Operations Managers

Quality Assurance personnel

Plant Managers and Supervisors

Manufacturing Superintendents and Managers

Individuals whose job knowledge and/or expertise may be called upon during an audit

Regulatory Affairs Managers

Learning Objectives:

Upon completion of this session, attendees will learn the proper way to set up for a Regulatory Inspection, ensuring the inspection flows smoothly throughout the duration, and the proper way to speak to inspectors while they are performing the audit.

Webinar includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of attendance