FDA requires equipment in the pharmaceutical and medical device industries to be qualified before scientists and engineers are trained on its operation and subsequent use. Qualification is important as it determines that the equipment functions as the vendor intended, and is capable of supporting the work being performed for a reasonable amount of time. Any failures in equipment generally lead to research or production slow-downs, lost revenues, sanctions, or worse. As a result, starting with robust and compliant qualification efforts is a must to mitigate risk and ensure success.
When qualifying, most errors happen during testing. Improper testing may result in delays in work, late product launches, slow or stop production, and may have a negative impact on FDA submissions. Again, failure to qualify may result in anything from a FDA 483 citation to a plant closure.
With demanding timelines and various guidelines from FDA, ISPE, and USP, it can be difficult to determine how to put the regulations into practice so that equipment performs consistently and reliably.
Join our interactive online training course to learn tips and tricks for executing, as well as streamlining, qualification activities. You will learn what is most important in the process, and common areas of failure.
Upon completion of the course, you will:
- Recognize what should be tested as part of your qualification process
- Determine how much should be tested to comply with equipment qualification guidelines
- Establish best practices for documentation
- Analyze ways to expedite the qualification process
- Understand the top pitfalls, and how to resolve them