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Clinical Trials and Pharmaceutical Root Cause Analysis Training


Today, clinical trial professionals are provided with guidelines, regulations, company policies, procedures, and endless amounts of training to help them with the conduct of clinical trials.

Despite all the training, guidelines, regulations, company policies, and procedures in place to assist with the conduct of a clinical-trial, problems including unanticipated situations or safety issues arise.

Clinical research professionals are often unable to give their full attention to every detail of the study due to the speed in which the trial progresses, the strain on company resources, or many of the other day-to-day factors that impact ones’ time and attention.


This is why the pharmaceutical industry has turned to root cause analysis (RCA), an important approach for identifying the underlying causes of an incident so that the most effective solutions can be identified and implemented – rapidly.

In FDA-regulated industries, root cause analysis (RCA) is perhaps the most frequently used tool for identifying the source of a good manufacturing practice (GMP) deviation and determining an appropriate corrective and preventive action (CAPA).

RCA has become especially important to pharmaceuticals in clinical trials. RCA analysis within clinical trials is primarily formally used when implementing corrective and preventative actions internally or externally linked to other stakeholders.

Clinical trials today are complex multi-disciplinary processes involving multiple partner entities working together to satisfy stringent regulations to improve patient lives by bringing innovative therapy to the market. Due to competitive nature of the pharmaceutical industry, there is a push toward increasing efficiency in order to deliver on-time, on-budget accurate representation of clinical trial data to regulatory authorities.

RCA methodology can save time and money as it leads to investigating events of undesirable programming quality and provides a corrective intervention to prevent its future occurrence.

With the pharmaceutical industry focus on building better clinical quality systems that include risk management, the use of proactive RCA at all levels of performance management in clinical trials is essential such as during risk assessment.

There are considerable occasions where root cause analysis (RCA) can be used in running clinical trials, but not just for non-compliance root cause assessment.

Another important opportunity to use root cause analysis is in an anticipatory environment. RCA can support the conciliatory effort of sponsor and/or investigational site cross-functional teams to identify why something could go wrong within a study.

Additionally, root cause analysis tools can link interventions directly to the root cause to better mitigate risks — especially when linked to risks to human subject protection, quality data and project milestones.

Clinical Trials and Pharmaceutical Root Cause Analysis Training Courses by Tonex

Clinical Trials and Pharmaceutical Root Cause Analysis Training is a 2-day workshop style, hands-on training course designed for professionals in clinical trials, biotech and pharmaceutical industries.

Tonex’s Clinical Trials and Pharmaceutical Root Cause Analysis Training workshop ensures professionals involved in conducting investigations learn more about the RCA tools and gain practical knowledge to drill down to the root cause(s) of an event.

Participants learn about structured techniques such as brainstorming, 5 whys, 6 Ms, 6 Ss, Fishbone Diagram, (Ishikawa)/Cause & Effect Diagram along with other concepts and tools commonly used to assess risk and performing Corrective and Preventive Action.

Using use of cases, case studies, and group hands-on exercises, the training workshop provides tools and techniques to investigate, conduct in-depth analysis, generate investigation reports and correct the issues.


Who Should Attend?

  • Biotech, pharmaceutical, biologists and medical device specialists and professionals
  • Pharmacovigilance & Drug Safety Specialist
  • Directors and Project Managers
  • Operations/Support Manager
  • Quality assurance and control, safety, risk, safety, manufacturing and packaging  professionals
  • R&D team
  • Production managers
  • Clinical trial professional
  • Product engineers and designers
  • Anyone responsible for the failure and deviation investigation process in a GMP 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.

Training Objectives

Upon the completion of Clinical Trials and Pharmaceutical Root Cause Analysis Training, the participants are able to:

  • Learn the basic  theory of root cause analysis and how it is applied to Clinical Trials and Pharmaceutical industry
  • Define problem statement in an unambiguous way
  • Use appropriate methods for gathering data
  • Explain all the steps of root cause analysis
  • Apply brainstorming, process mapping and regulatory resources, tools and techniques  to determine all possible causes
  • Use brainstorming tools to produce ideas for solutions
  • Discuss all the benefits and drawbacks of each solution to figure out the best and the most efficient one
  • Watch the implemented solution(s) to assess its effectiveness
  • Derive an efficient action plan
  • Identify high-risk situations and perform possible preventive actions
  • Derive a successful preventive plan
  • Recognize common limitations of root cause analysis and find approaches to remove those barriers
  • Search through the possible root causes of a failure and not just a quick fix

Training Workshop and Course Agenda

Introduction to Clinical Trials and Pharmaceutical Regulatory

  • Deviations in clinical trials
  • Most optimal Standard operating procedures (SOPs) for deviation investigations
  • FDA (21 CFR and Guidance Documents)
  • EU (Eudralex, Volume 4)
  • ICH
  • FDA 483s and Warning Letters
  • Landmark case

What is Root Cause Analysis (RCA)?

  • Identifying the underlying key causes behind review findings
  • Why is RCA important?
  • How RCA might be performed?
  • Who should perform the root cause analysis?
  • When should root cause analysis be performed?
  • Methodology of root cause analysis
  • Defining the deviation
  • Risk management
  • Internal control
  • Investigation process steps
  • Investigations and data gathering
  • Skills and tools of an effective investigator

Overview of Common Root Cause Analysis Tools and Frameworks

  • “Is/Is Not” technique
  • 5 Whys/Five whys
  • 8D methodology
  • Affinity diagrams
  • Awareness and problem definition
  • Barrier analysis
  • Brain storming
  • Brainstorming tools
  • Cause and effect diagrams
  • Corrective Actions and Preventive Actions (CAPA)
  • Define, measure, analyze, improve, control (DMAIC)
  • Failure modes and effects analysis (FMEA)/Process FMEA/Design FMEA
  • Fault Tree Analysis (FTA)
  • Flow diagrams
  • Hazard analysis and critical control points (HACCP)
  • Impact assessment
  • Ishikawa diagrams (Fishbone)
  • Kepner-Tregoe
  • Mind mapping
  • Pareto charts
  • Pivot tables
  • Process mapping
  • Relations Diagram
  • Risk tree
  • Root-cause Analysis Tools and Methodologies.
  • Run charts
  • Statistical methods and sampling
  • Statistical process capability analysis
  • Statistical process control
  • The interview
  • Trend analysis
  • Trending

Case Study 1

  • Root Cause Analysis with Examples
  • Identifying Root Cause
  • Corrective and Preventive Actions (CAPA)
  • Common barriers and solutions
  • Management of the investigation
  • Organizational Culture
  • Policy and Standard Operating Procedures (SOP)
  • Problem statement
  • Risk assessment
  • Data analysis
  • Objective risk assessment and scoring
  • Outcomes/Benefits to Client (ROI)

Workshop 1: Performing A Root Cause Analysis Project

  • Gather and Manage Evidence
  • People
  • Who was involved, what roles did they play, and who else is knowledgeable about the event? Procedures & Documentation
  • What procedures were involved?
  • Were they formal or informal?
  • Were procedures followed?
  • Were they accurate and complete?
  • What systems were involved?
  • What was their purpose and what role did they play in the event?
  • What was the work environment during the audit?
  • Was there schedule pressure?
  • Was the client collaborative?
  • Was there cohesion on the audit team?
  • Did the team feel supported at each step?
  • Write the Problem Statement:
  • Analyze Cause and Effect
  • What caused the effect?
  • Solutions
  • Reporting
  • Closing

Workshop 2: Working with Root Cause Analysis Frameworks

  • Root Cause Analysis for Drug makers and Pharmaceutical
  • Root Cause Analysis for Clinical trials
  • Kepner-Tregoe Problem Solving and Decision Making
  • Corrective and Preventive Action (CAPA)
  • 8D
  • Tracking and Trending
  • Key Elements of the Investigation Report
  • Analysis Techniques
  • Building a Sample Causal Factor Tree
  • Example Causal Factor Chart
  • Determining Potential Product Impact
  • The effectiveness of the CAPA

Clinical Trials and Pharmaceutical Root Cause Analysis Training

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