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Limited Availability until April 19, 2024
Whether your operation is covered by GMP, GLP, or GCP, there is a regulatory requirement to ensure that all equipment used has been properly demonstrated and documented to be functioning properly. Commonly referred to as Installation Qualification, Operational Qualification, and Performance Qualification. IQ/OQ/PQ provides the framework under which this process can be appropriately performed. Overlooking this critical first step or improperly performing it can invalidate any data generated.
The course will explore the regulatory requirements associated with GxP environments. Adherences to GxP (i.e., documentation, laboratory, manufacturing, clinical), are precursors to medical/pharmaceutical production because it is codified (21CFR).
This training will delve into the controls and laws needed to support GxP in Equipment Qualification. In addition, discussions will include the current understanding of the use of Automated Equipment focusing on the Good Automated Manufacturing Practices (GAMPs).
Upon completion of this course, you will be able to:
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This webinar has been designed for professionals in the Pharmaceutical, Medical Device, and Biopharmaceutical industries. It will especially benefit engineers and scientists engaged in any FDA-regulated areas. Those working in validation, engineering, and manufacturing will find the course very valuable. In addition, managers and supervisors in these departments will also find the course beneficial.
• Engineers
• Manufacturing
• Managers
• Supervisors
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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