The Key Essentials of Effective Regulatory Inspections

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Feb 21, 2017
60 minutes
Product Description

Best Practices to Ensure a Smooth and Complete Regulatory Inspection to Demonstrate CFR Compliance

The purpose of a regulatory inspection is conducting an activity which demonstrates that your company is operating according to the proper CFR requirements and has been 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 can be a daunting experience for some.

This webinar by expert speaker Danielle DeLucy, MS, will help you prepare and plan for regulatory inspections and ensure that inspection activity flows smoothly with minimum disorder. You’ll learn how you can properly alert key members that an investigator has arrived; what proper protocol you need to follow for setting up the inspection room and any associated “war” rooms that will support the inspection; and how you can manage requests from the investigators in a timely and accurate manner.

The information in this presentation emphasizes on helping you minimize stress and disorder during regulatory inspections. Upon completion of this session, you will learn the proper way to set up for a regulatory inspection; how to properly speak to inspectors during the audit; and ensure that the inspection is smooth and effective to demonstrate your compliance to CFR requirements.

Session Highlights

  • Learn how to set up support groups/rooms for the inspection
  • Learn how to properly communicate with the inspector
  • 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
  • Learn how to use your internal Quality Assurance groups to help identify issues prior to an inspection
  • Learn how to deal with certain tasks, including:
    • 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 should attend?

  • 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

At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Danielle DeLucy

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous...   More Info
More Events By The Speaker

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