Industries: Pharma / Biotech

Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy

Course Director: Kerry Potter

Course Fee: $2650.00 Regular Registration / $2450.00 Early Bird (30 Days in Advance)

Course Description -

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

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.

Course Agenda

First Day

Course Introduction and Expectations

Regulatory Expectations for Investigations

  • FDA (21 CFR and Guidance Documents)
  • EU (Eudralex, Volume 4)
  • ICH
  • FDA 483s and Warning Letters
  • Landmark case

Investigation Process Overview

  • Purpose, basics and sources (types and categories) of investigations
  • Elements of a thorough investigation process (Discovery through
  • Closeout)
  • Classification levels
  • Investigation planning, action items and documentation
  • Company culture

Skills and Tools of an Effective Investigator

  • Characteristics and techniques
  • Reading and documentation practices
  • Technical writing

Second Day

(Re) Introduction to Root Cause Analysis (RCA)

  • Principles of root cause analysis
  • Why root cause analysis is difficult
  • Methodology of root cause analysis

Defining the Deviation

  • The problem statement
  • Active listening and interviewing
  • Process mapping
  • Brainstorming tools
  • "Is/Is Not" technique

Identifying Root Cause

  • 5 Whys
  • Relations Diagram
  • Ishikawa diagrams (Fishbone)
  • Fault Tree Analysis vs. Failure Modes and Effects Analyses (FMEA)
  • Challenges

Third Day

Corrective and Preventive Actions (CAPA)

  • What is the CAPA System
  • Definition and regulatory interpretation
  • Identifying and writing of corrective actions
  • Abuses of the CAPA system
  • Discuss robustness and effectiveness review

Management of the investigation

  • Members of the Investigation Team
  • CAPA management/team

Members of the Investigation Team

  • Culture
  • Compliant document extensions and interim reports (justification)
  • Management communication and notification
  • Metrics and trending
  • Interim controls, timetables and other reports
  • Policy and Standard Operating Procedures
  • Escalation action assessment
  • Common barriers and solutions
  • Investigator training

Wrap Up and Review

Learning Objectives

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.


"The best course I’ve taken!! I enjoyed the interactions, dialog, and exercises." Theodora M., QA Manager, Solid Biosciences
"Great course with many activities which gives us a chance to brainstorm and learn for ourselves." Megha S., QA Systems, Dr. Reddy’s
"I was extremely pleased with the instructor and how to approach deviations investigations. I thought Day 3’s case study was great in capturing all of the skills provided by the first two days. The structure of the course works well because there is a buildup of skills that set the platform to helping identify root cause analysis." Cassie P., QA Associate, Wave Life Sciences USA
"Much more informative vs. other training providers. I really enjoyed the case study and being able to use the planning and interview techniques to find the root cause of the problem." Lauren M., Quality Documentation Scientist, Puresyn
"This course provided more information and real life examples than others I’ve attend with different training providers. The instructor was knowledgeable and the course was well structured." Stephen B., Snr. Manufacturing Specialist, Amicus Therapeutics
"This course covered a lot of different techniques to conduct root cause analysis and investigations. Also covered so many other areas like flow charts, metrics, interviews, websites that are good sources. Other courses I’ve taken have only concentrated on one thing." Dyliana F., Stability Coordinator, Unipharma
"This was the best course I’ve ever taken." Luz M., Quality Systems and Compliance Mgr., Unipharma
"The instructor engaged the audience and delivered information that was clear to understand." Kimberly S., Manager, Talent Acquisition, Amicus Therapeutics
"This course was great compared to others I’ve taken with different training companies." Viviana C., Senior Quality Specialist, Agios
"Super in-depth and full of hands on activities to keep everyone engaged." Srvidya R., Principal Technical Specialist, Eurofins Lancaster Labs
"This course was more informative and very hands-on compared to others I’ve taken." Danielle H., Quality Compliance Manager, RemedyRepack
"This course was very worthwhile! I would highly recommend it to my peers." Mary A., Senior PV Specialist, Pharmacyclics
"The course was very comprehensive. The examples were real-life situations that made you understand the techniques and made the information much easier to comprehend." Mark T., QC Director, Amicus Therapeutics
"This has been the most fun and interesting trainings I have ever attended. I feel like I learned more than I have in similar trainings. The instructor was great and I enjoyed the quality/quantity of the take-home materials and the hands-on activities." Melissa C., Senior Manager Quality Systems, Abbvie Stemcentrx
"PHENOMENAL! Highly interactive. The instructor used powerful examples and activities. The problems were derived from actual situations." Oscar T., Program Manager, The Henry Jackson Foundation for Military Medicine
"This course provided very good examples and case studies. The course Director kept us focused and made the topic interesting." Ines L., Validation Team Lead, Hovione FarmaCiencia
"The instructor was very engaging, knowledgeable and challenged us to think through things using the tools he gave us." Christine B., Manager GMP Manufacturing, Moderna Therapeutics
"Fantastic! Great course and the facilitator was phenomenal." Joseph T., Validation Specialist, Commissioning Agents (CAI)
"This was one of the best training courses I have ever attended. The material is very useful in my work, even though I don’t do many investigations." JoAnn B., Assoc. Manager Doc Control, Gilead
"The Course Director is a very good instructor and kept the class engaged for 2 days. Lots of opportunity to practice what you learn. I feel I have a better understanding of how to use the tools." Duval C., Sr. Manager – Quality, Gilead
"The course was great, and I learned several valuable tools to help with my daily work tasks. Our instructor was very good at keeping the room "alive", and allowing us to figure out the problems for ourselves with some guidance. I would recommend this course to anyone in the industry that has dealings with root cause and CAPA." Carl S., Manufacturing Supervisor, Thermo Fisher Scientific
"The course was well-planned, timed and executed. The instructor was able to keep the group engaged by performing multiple group activities (case studies, projects). The instructor also fielded the groups' questions effectively and was able to relate the course material to real time issues concerning MTF. I took away the important lesson of drilling down to the true ROOT cause, defining the scope, and not jumping ahead before truly defining the root cause or trul ruling out any additional scenarios." Greg N., Assoc. Manager Contracts & Value Analysis, MTF
"This training was an eye opener. I am walking away from this, feeling like MTF will find the true root cause 90% of the time – instead of 10%. Thank you!" Cindy H., QA Compliance Specialist, MTF
"Would not change anything about the course! Great job!!" Jim. D., Sr. QE, Bruker Daltonics
"The Course Director was very knowledgable and supportive. He was willing to take extra time to help everyone and was a great presenter. Good use of time and a mix of activities and lecture." Jaclyn F., Validation Engineer, Genzyme
"Excellent delivery of information with consistent methodology of events/topics." Ronald Z., Production Sub-assembly Supervisor, Bruker Daltonics
"The class is perfect! The Course Director provides good examples and the class was very interactive. The instructor is very experienced and brings great industry examples to make us understand it better." Hitesh B., Industrial Engineer, Forest Laboratories
"Good overview of the tools, processes, and regulatory requirements of the investigation (CAPA) process. I will go away with a different interpretation and make some changes and improvements to our current CAPA process - with this, will also make some personal changes." Wayne A., Plant Manager, Rockline Industries
"This course has the information to take you to the next level. The interactive nature of the course was fantastic. CAPA and Root Cause can effect each company at a different level, and the unique perspectives provided by the Course Director were excellent. I am extremely pleased with the knowledge that I am taking back with me." Donna C., Manager of QA and RA, Positron Corporation
"Great instructor! Well schooled. Teaches well. Personable. Keeps the class interesting." Mike P., VP, Director of Operations, Celeste Ind. Corp
"The case studies were excellent and working in a team environment was a great exercise. The Course Director blended the right amount of interaction between attendees made the training interesting and beneficial. It is a great course for introducing CAPA and RCA analysis. I recommend the course to any GMP compliance related personnel." Jennifer L., GMP Compliance Manager, Pfizer
"The Course Director was superb. I really enjoyed the group project parts of the course." Darby O., QA Associate, Dendreon Corp.
"This was a fantastic course! It not only simplifies the CAPA process, it provides enough information to implement a CAPA system or improve on existing CAPA system." Sandra L., Sr. Manager, QC, Hollister Stier
"I definitely enjoyed this course a lot. I learned new material even after working in the pharmaceutical industry for over fifteen years! Thank you!" Jose C., Quality Specialist, Amgen

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.