Failure Investigations

Course Description

This course is designed for manufacturing, quality control, quality assurance and others operating in a cGMP environment. This course focuses robust, efficient system for conducting failure investigations; how to obtain relevant data and communicate with various departments; what to include in an investigation; and how to use this information to build a case for product disposition and appropriate, effective corrective and preventive actions. With a focus on documentation, application of good technical writing skills to compiling an investigation report will be explored.

Course Topics

Each course can be customized to the learning needs of a particular organization. Following is a list of topics available for this course:

Introduction to Failure Investigation

• "Failure" defined within the GMP Operation
• Failure and the need to investigate
• Implications of failure investigation - patient, product, business
• The regulators - FDA's view

Elements of Failure Investigation

• Description
• Inquisition - building a case by gathering evidence
• Writing techniques
• Conclusion

Case Studies for GMP Operations

• Raw materials
• In-process materials
• OOS and laboratory failures
• Compliance failures
• Post distribution product

Failure Investigation in an Effective Quality System

• Failure reporting
• Conducting failure investigations
• Failure investigations and corrective action
• Failure investigations and preventive action
• Risk Assessment and Management
• Managing and defending failure investigations
• Continuous improvement

Instructors

• Frank Matarrese, GxP Consultant