Equipment Qualification in the GxP Environment

Duration: 90 Minutes
Course Instructor

Joy McElroy

$ 195
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

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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. Adherence to GxP (i.e., documentation, laboratory, manufacturing, clinical), are precursor to medical/pharmaceutical production because it is codified (21CFR).

The accredited training will delve into the controls and the laws needed to support GxP in Equipment Qualification. In addition, discussions will include the current understanding of the use of Automated Equipment focusing on Good Automated Manufacturing Practices (GAMPs).

Upon completion of this course, you will be able to:
• Articulate the reasons for GXP for respective role
• Explain what makes good equipment/manufacturing controls
• Describe the repercussions associated with not adhering to GXP

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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

Course Instructor

Joy McElroy

Joy McElroy

Consultant to the Pharmaceutical and Biotech Industries

Joy McElroy’s Courses


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