Overview: This program is intended for those personnel who are concerned with the analysis and correction of problems (deviations and failures).
This course provides clarity to the regulatory expectations and guidance, and to the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and notification through documentation. Participants will review root cause analysis techniques and observe how to identify corrective and/or preventive actions towards successful remediation and closeout. This high-level overview will provide clarification on the steps of an effective investigation, what documentation is required along the way, and how to establish a comprehensive and compliant investigation system.
Why should you attend: Inadequate failure investigations continue to be a major GMP deficiency cited during routine and "for-cause" inspections conducted by the FDA. While the FDA recognizes that failures are a part of business, it expects comprehensive investigations of those failures, the application of scientific judgment and sound solutions to the identified problems. This webinar highlights a successful approach to the identification of deviations and failures, the failure investigation plan, and effective root cause analysis for corrective actions.
Areas Covered in the Session: - Elements of a thorough investigation process (Discovery through Closeout)
- Identifying the Problem
- Introduction to Root Cause Analysis
- Define corrective action and preventive action
- Effective Documentation of the Investigation Process
- Skills and Tools of an Effective Investigator
Who Will Benefit: The content will be beneficial to those with new responsibilities in the area of investigations or those who would like to refresh their knowledge of the investigation process.
- Pharmaceutical manufacturing and packaging
- Quality, Manufacturing
