COURSE ID 3044

Successful FDA Inspections: Essential Preparation and Management Tools

AVAILABLE On-demand
12 Hours

On-Demand

Offering Price
$ 2150
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Team Training

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.

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Remember – 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.

Regulatory inspections should demonstrate that your company is operating according to proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate the ways in which your quality systems assure this state of control. The arrival of a Regulatory Investigator can be a daunting experience.

In this 12-hour intensive and accredited ON DEMAND training 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 can assure your confidence and minimize stress and disorder during the inspections.

This overview training has been designed for the needs of professionals in all areas of the life sciences including pharmaceutical and biopharma science, medical devices, analytical chemistry, clinical and pre-clinical and specialty chemical.

Attending this training is beneficial to professionals in:

– Quality Control

– Quality Assurance

– Research & Development

– Technical Operations

– Contract Manufacturers

– Manufacturing and Filling Operation

Regulatory affairs personnel as well as individuals who are responsible for the review or audit of inspections and reports should likewise consider participating in this training.

course instructor

Danielle DeLucy, MS
Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, MS’s Courses
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.