Effective Regulatory Inspections
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Course Description:
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 should you 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.
- Upon completion of this session, attendees will learn the RIGHT 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.
- To learn how to use your internal Quality Assurance groups to help identify issues prior to an inspection.
Areas Covered:
- 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 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
Registration Options
Speaker Details
Danielle Delucy
Pharmaceutical Expert
Danielle DeLucy, prior to this role has been in the industry for 13 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 filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years
Refund Policy
Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplianceTrain will issue a letter of credit to be used towards any of ComplianceTrain's future events. The letter of credit will be valid for 12 months.
ComplianceTrain will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@ComplianceTrain.com
