Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This course highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis.
The primary objective of this course is to recognize the value of conducting proper root cause analysis and documenting failure investigations. Emphasis is placed on the application and practical, hands-on aspects of how to facilitate root cause analysis. Additionally, the course will provide attendees with the principles and techniques involved in identifying failures and deviations, categorizing problems, assigning responsibility and tracking team activities.
Additional benefits of this class include:
- Learn not just from the Director, but tap into the knowledge of your peers: Participants will have the opportunity to anonymously submit their challenges, problems, and issues for classroom discussion. Ample time is provided to address specific problems and questions of individual participants
- Explore the use of brainstorming, process mapping and regulatory resources
- Participants will also have the opportunity for one-on-one consultation with the Course Director during course breaks and in the evenings
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
This Root Cause Analysis training course is designed for personnel who are responsible for the failure and deviation investigation process in a GMP environment, specifically Root Cause Analysis for CAPA. These include, but are not limited to, positions in Manufacturing and Packaging, Quality Assurance/Quality Control, and those support groups who initiate, conduct and/or manage investigations in a pharmaceutical, clinical manufacturing, biologics and medical device environment. This course will be practical in its application and particularly valuable to those newer to this field or those who wish to refresh their knowledge of root cause analysis and investigative techniques.
This course provides clarification of regulatory expectations and guidance, and 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 practice root cause analysis techniques and identify corrective and/or preventive actions towards successful remediation and closeout.
Attendees will gain a perspective of effective interviewing and writing skills, discuss common pitfalls, and develop tips and techniques for thorough investigations and elimination of recurring failures and deviations. Additionally, attendees will learn through hands-on activities such as group discussions and case studies tailored to regulated industries.
Frequently Asked Questions
My group does not produce commercial products, only clinical. How would this course help my organization?
Regulatory aspects of investigations and corrective/preventive actions from pharmaceutical, medical device and biological regulations are presented. However, the course material is presented, demonstrated and practiced so as to be applicable to any industry.
Nearly all deviations are caused by human error; why would I invest time and money in such a course?
True - the majority of deviations are detected as a result of human error. However, what we need to determine is what caused the error. This course demonstrates (and allows participants to practice) how to reveal what was the underlying source (root cause) that caused the human (or material or machine) error to occur.
My company is a small organization. The material appears to be geared for larger organizations that have resources and time to commit to the investigation process.
While it may appear that way, the material is presented so that any organization can adopt and adapt the principles, techniques and roles of the investigation process and root cause analysis. The "take home" of the course is utilizing all of these elements in a way that streamlines your investigation process and enables your company to conduct them in a timely fashion.