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.
Who should attend?
At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.
- Dr. Karl Lintner,
- Norma Skolnik,
- Danielle DeLucy, MS
- Edward F. O’Connor, Ph.D.
- Dr. David Lim, Ph.D., RAC, ASQ-CQA
- Edwin Waldbusser,
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 Events By The Speaker