WHAT YOU WILL LEARN

Manufacturers follow Good Manufacturing Practice (GMP) guidelines to ensure high quality products, meet standards required by the U.S. Food and Drug Administration and to open up new markets for their products.

The course presents and illustrates ten overarching principles of GMP using lectures, case study examples and selected FDA guidance documents. In-class practical examples are used throughout the workshop with significant emphasis on sanitary design, validation and process control. Attendees will learn how GMP works in practice and how to identify non-compliance in their own manufacturing environments. Attendees will also learn how to validate a manufacturing process or unit operation and ensure that new equipment is installed and commissioned in accordance with GMP guidelines.

This workshop is designed to help attendees see GMP as part of a total quality control system and bring more manufacturing discipline to their organizations.

This course is eligible for EMCI PDUs