Global Compliance Investigative Service (GCIS)

$695.00$1,390.00

Description

Overview: 

Global Compliance Investigative Services is a GMP Refresher program that illustrates three different types of incidents that involve 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 the root cause of problems
  • Check anything out of the ordinary in your processes
  • Quality is ensured by following procedures

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

Objectives:

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

  1. Recognize and recall that there are quality systems providing checks and balances in all departments that ensure our products are safe and effective.
  2. Recognize that change control is a critical process and changes must be reviewed, approved and communicated.
  3. 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

  1. 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.
  2. 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.
  3. 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!

 

DVD Running time: 25 minutes

Program package includes:

  • Leader’s Guide
  • Discussion Guide and Answer Key
  • Assessment and Answer Key

Click below to see the program Introduction.

Click below to see a sample of the Gritty Water System

Click below to see a sample of The Woozy Patient

Click below to see a sample of Do Particles Matter?

Additional information

License Type

Single Use (Play on 1 Computer or use DVD Player and Monitor) ($695), Network/Plant Wide (WMV Files for Use on Shared Drive) (+$695.00)

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