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FDA Inspection Essentials
Module 1: FDA Inspections 101
- Unannounced FDA visits – how to prepare and react
- Preparing for FDA audits / PAI preparation – what training should look like for key players
- Basic concepts that should be employed by everyone regulated by the FDA – review of quarterly quality topics to keep current
Module 2: Company Preparedness
- How a company can prepare for situations like this – training SMEs and beyond
- How a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business
Module 3: Observations and Lessons Learned
- How should a company respond to 483 observations or a warning letter – deadlines, tracking, and closures
- Lesson learned – reviews of the observations and overall inspection experience
Module 4: Real-Life Situations
- Case Scenarios – review of real-life scenarios that you could encounter during inspections
Overview of the webinar
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 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.
Who should attend?
- Quality Control Personnel & Management
- Manufacturing Personnel & Management
- Senior Management
- Regulatory Affairs Personnel & Management
- Quality Assurance Personnel & Management
Why should you attend?
- Upon completion of this session, attendees will:
- Learn Pre-planning and preparation activities
- Know What to do when the investigator arrives
- Know What documents to have ready and on hand
- Develop Assignments and responsibilities for the inspection
- Be Aware of Inspection Do's and Don'ts
Faculty - Miss.Danielle Delucy
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.