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When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
Learn moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
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. In this accredited, 90 minute online course, 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.
This training is essential background information for anyone who will interact with FDA during an inspection. Learning what to do and what not to do will improve inspection outcomes and this gained knowledge will be particularly beneficial to professionals in the following areas:
– Quality Control
– Manufacturing
– Senior Management
– Regulatory Affairs
– Quality Assurance
Managers and supervisors of this personnel will also benefit from this training by learning about the challenges faced by them.
Danielle DeLucy, MS
Owner, ASA Training & Quality Consulting LLC
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 23 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.