Reporting Failure Investigation and Process Deviations

Because of its comprehensive content, this course will prove most valuable to personnel in research and development, manufacturing, quality assurance, and quality control laboratory, who are involved in conducting and reporting failure investigations and deviations.

This includes but not limited to directors, managers, supervisors, team leaders, and scientists from a GMP environment, needing in depth knowledge on conducting and reporting failure investigations and process deviations.

Learning Objectives

Providing a step-by-step foundation for conducting failure investigations, this training course highlights FDA requirements and quality assurance overviews on how to document the results from your failure investigation. Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause U.S. Food and Drug Administration (FDA) inspections. The FDA recognizes that failures are a part of business but also expects comprehensive investigations, the application of scientific judgment, and learning from the experience and permanent solutions to the problems identified.

This course provides clarification on the scope of relevant guidance and the essential skills necessary to ensure compliant documentation. Attendees will examine each step of an effective investigation and learn what documentation is required along the way, perform Root Cause Analysis and explore FDA expectations regarding CAPA. Additionally, participants will learn to avoid common obstacles to success and practice conflict resolution skills. This three-day workshop outlines tips and techniques to improve failure investigations and identifies proposed corrective action which ensures successful implementation and closeout.

Course Description

This continually updated course covers appropriate reporting of failure investigations and process deviation to satisfy FDA regulatory requirements. Among the topics to be discussed will be:
Discussion on FDA expectations regarding failures and process deviations
Exploring deviation or incident reports, nonconforming material reports
NCR (nonconformance report)
Out-of-Specification (OOS) results and validation failures
Examining roles, responsibilities and guidelines for documenting the investigation
Analyzing challenges and solutions for improving the review and approval process
Examining best practice elements of technical writing
Examining how each component fits within the CAPA system
Performing Root Cause Analysis using best practice, step-by-step tools
Documenting fact-based conclusion and proposed corrective actions
Recommending and implementing Corrective Actions
Auditing the failure or process deviation investigation to ensure follow-through and completion, Anticipating and avoiding common barriers and obstacles