In this course, you will be provided with a general awareness of FDA inspections of pharmaceutical testing and manufacturing facilities, including purpose, types, and areas/operations typically inspected. You will also explore how firms should handle FDA inspections and interact effectively with FDA Investigators.
This course will educate the learner about the importance of properly responding to reports of alleged medical device problems. The learner will be able to apply this knowledge to handle complaint events in compliance with FDA regulations.
After completing this course, you will be able to identify the primary elements in an effective pharmaceutical complaint handling system. You will also recognize how to document complaint information as required by FDA regulations and understand the basic requirements for complaint evaluation and investigation. You will be able to recognize the types of complaints that must be reported to FDA according to the Adverse Drug Experiences regulations, and identify the importance of using statistical techniques to identify complaint trends that may indicate potential quality problems.
This course introduces the learner to FDA design control regulations by providing basic information about the key procedures followed during the design and development of a product. The design plan requires documentation of training, planning validation, design transfer and changes, formal review, a design history file, and human factors.
After completing this course, you will be familiar with the FDA requirements for manufacturing plants and grounds including design and construction, and requirements for sanitation, equipment and utensils, automated equipment, contamination prevention, and record keeping.