Overview: This course will review the regulatory requirements and expectations for the deviation management process, describe the roles and responsibilities of personnel associated with the investigation system, and identify principles of and techniques involved in the practice of facilitating a root cause analysis. Additionally, the sources of deviations and investigations will be examined as well as documentation of the process.
Why should you attend: Inadequate failure investigations continue to be a major GMP deficiency cited during routine regulatory inspections. Most often, companies are cited due to a lack of knowledge of the regulatory expectations and guidance, and not developing the essential skills necessary to ensure effective and efficient investigations. This program will examine each step of an effective investigation process from identification and notification through root cause analysis and development of corrective and/or preventive actions. This material will review FDA and EU regulations, and how to successfully approach a failure investigation and engage in subsequent root cause analysis.
Areas Covered in the Session:
Elements of the Investigation Process
Skills and Tools of the Investigator
Root Cause Analysis Techniques
Who Will Benefit:
Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development.