Proper Management of Regulatory Agency Inspections
Danielle DeLucy, MS, is the 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 filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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.
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.
- 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
Why 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