COURSE ID 3036

Equipment Qualification in the GxP Environment

AVAILABLE LIVE ONLINE
Date(s) and Time:
May 2, 2024
11:00am EDT - 12:30pm EDT
Duration: 90 Minutes

Can't attend the live course?
Select the on-demand option during registration, and we will automatically send you the recording when it is ready.

Course Instructor

Joy McElroy

Early-Bird Offer

Limited Availability until April 19, 2024

$ 265
Price
$ 295
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

View Course Outline

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:

  • 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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