Global Compliance Investigative Service (GCIS)

Global Compliance Investigative Services is a GMP Refresher program that illustrates three different types of incidents that involved cGMPS. The program follows an investigative service team as they try to determine the root cause of each incident.

Through the investigations, three key rules are emphasized:

• Investigate thoroughly to find root cause of problem
  
• Check anything out of the ordinary in your processes
  
• Quality is ensured by following procedures

The program reminds participants the importance of adhering to Good Manufacturing Practices.

Objectives:
At the end of this program, participants will be able to:

• Recognize and recall that there are quality systems providing checks and balances in all departments that ensure our products are safe and effective.
• Recognize that change control is a critical process and changes must be reviewed, approved and communicated.
• Recognize and describe that deviations in the manufacturing process must be investigated to ensure the quality and purity of drug products.

Topics:

• I. Introduction
• II. Program Objectives
• III. Investigations

The Case of the Woozy Patient: When a patient complains that they are feeling woozy--and perhaps didn't get their full dose of product, there are several areas to investigate. The team looks at the packaging and filling, dispensing laboratory and lot release to try and determine how a low fill could have occurred--or did it? This case illustrates the need for a thorough investigation to determine root cause.

The Gritty Water System: Particulates are found in the water system--but where did they come from? Could a new cleaning solution be the culprit? Follow the investigative team as they try and determine a root cause but also put the company's change control process under the microscope.

Do Particles Matter? They do if they get into a batch. But if the particles are eliminated in the filter system is that acceptable? The GCIS team takes on this case to determine--if particles do matter!

Program package includes:

• DVD: Running time: 25 minutes
• Leader's Guide
• Discussion Guide and Answer Key
• Assessment and Answer Key

This product is shipped directly from the US producer.