COURSE ID 3036

Equipment Qualification in the GxP Environment

AVAILABLE On-demand
90 Minutes

On-Demand

Offering Price
$ 295
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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

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 90-minute accredited ON DEMAND webinar 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 the Good Automated Manufacturing Practices (GAMPs).

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 and Supervisors

 

 

course instructor

Joy McElroy
Consultant to the Pharmaceutical and Biotech Industries

Joy McElroy’s Courses
Joy McElroy, has 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies. Ms. McElroy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2019 Ms McElroy started her own company, McElroy Training and Consultancy. She currently works with Easi.