Managing and Reducing Drug and Device GxP Deviations


8:30 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 10:00 a.m.

Introduction and Workshop Objectives
  • Why is it important to conduct thorough investigations?
  • What are the FDA/EU regulatory expectations for proper notification and investigations?
  • Why improve the quality of an investigation process?
  • Understanding key elements of the complete deviation handling process:
  • Discovery of a deviation
  • Assessing the event
  • Classifying the event
  • Conducting failure investigation
  • Identifying root cause
  • Identifying and implementing CAPA
  • Verifying CAPA’s effectiveness

10:00 a.m. – 10:15 a.m.


10:15 a.m. – 11:00 a.m.

What is a Deviation or Non-Conformance?

  • Interactive Exercise: Explore the different types of deviations and apply this knowledge to real-life events.
  • Defining and understanding “unplanned/unexplained” events versus “out-of-specification” events
  • How to determine that “something” has occurred and comply with corresponding FDA and international notification regulations?
  • Determining when certain events are controlled by local procedures and do NOT require notification to authorities
  • Creating SOPs that help all employees understand and consistently report deviations

11:00 a.m. – 12:00 p.m.

What are the First Steps During the Discovery of a Deviation? Assessing and Classifying Deviations

  • Best practices for assessing and evaluating information currently available
  • How to verify all calculations and raw data to best understand your starting point
  • Commonly overlooked steps to identify and define the appropriate initial procedures
  • 3 successful strategies for assembling a cross-functional team to investigate deviations
  • Conducting an impact assessment and determining event severity
  • The first 24 hours — how to determine the immediate impact
  • Analyzing the ongoing impact throughout the investigation phase
  • Tips for determining if an event is critical and could impact other batches or sites
  • Interactive Exercise: Writing a notification record that effectively communicates the who, what, where, when — but not the why — of an event. Attendees will collectively create a notification record that will be used throughout the workshop.

12:00 p.m. – 1:00 p.m.


1:00 p.m. – 2:30 p.m.

Best Practices for Performing Successful and Accurate Failure Investigations 

  • Proven techniques to pick effective investigation leaders and conduct successfulmstrategy meetings
    • Determining if leaders have the appropriate technical background and can devote the time
    • Communicate scope of meeting in advance — how to avoid the discussion going in 100 directions
    • Sharing all relevant background information creates more prepared participants
    • 10 tips for eliminating the common barriers to effective teamwork meetings
  • Executing a re-test protocol
    • Defining what will be tested
    • How to justify the number of replicates
    • Determining the criteria by which all results will be evaluated and results used
  • How to assure team members are not “testing into compliance”
  • Five tips to create effective investigation documentation
    • Capture events chronologically
    • Organize thoughts in order of importance
    • Remember the problem statement, “what happened?”
    • Capture ALL information
    • Discount nothing and be accurate — this is an investigation

2:30 p.m. – 2:45 p.m. 


2:45 p.m. – 5:00 p.m.

Qualitative Tools to Support Superior Root Cause Analysis — Discover What is Essential While Performing a Root Cause Analysis

  • Shout it out! Using flip charts, white boards, post-it notes and anything else you can find to capture ideas
  • Strategies to encourage idea capture — this is not the time to challenge ideas
  • Interactive Exercise: Brainstorming why pizza delivery times are longer on the weekends than weekdays. How many reasons can you come up with?
  • Best practices for using process maps as a problem solving tool — creating a process map for pizza delivery
  • Determining true cause and effect using fishbone diagrams to visualize problems and chart effective solutions
  • The five whys — how to take a precise problem statement and ask why… five times or more
  • Interactive exercise: Determine root cause of OOS potency assay. Determine team leader, apply problem-solving techniques, identify root cause and report to the group.
5:00 p.m.

Session Wrap-up


8:30 a.m. – 9:00 a.m.   

Continental Breakfast

9:00 a.m. – 10:45 a.m.

Integrating Quantitative Tools Into Your Root Cause Analysis — Identify Tools and How to Integrate Them Into Root Cause Analysis

  • Building effective and visually appealing run charts that allow teams to see and interpret variations
  • Incorporating Pareto charts into root cause analysis — how Parto charts can illustrate contributing factors and their order of severity or impact on a deviation
  • Interactive Exercise: Attendees will take data from a bar chart and create a Pareto chart to illustrate where problems lie — and will need to answer the following questions:
    • What does the resulting chart tell you?
    • Should a second level chart be created?
    • What other data would be useful?
    • What direction does this lead you?
    • What are your next steps?
  • Generating valid histograms and utilizing Kepner Tregoe models
10:45 a.m. – 11:00 a.m.


11:00 a.m. – 12:00 p.m.

Root Cause Evaluation and the Decision Making Process — Follow the Data

  • 3 strategies for determining the most probable root cause
    • Asking yourself and your team, “what do we really know?”
    • Determining what can be excluded from the final decision
    • Deciding what the data really tells you
  • How to determine if there can be more than one root cause. Best practices for separating primary from contributing causes
  • How to vet your root cause documentation — four questions you must ask yourself
    • Are all my activities in performing the investigation evident?
    • Did I ensure due diligence?
    • Have I captured everything relevant to this investigation?
    • Do I have all evidence that supports my conclusions?
12:00 p.m. – 1:00 p.m.


1:00 p.m. – 2:30 p.m.

Corrective and Preventive Actions — Managing the FDA’s #1 Inspection-Related Violation

  • Define and discover the difference between corrective actions and preventive actions
  • Case study: 6 common pitfalls where small and large companies have fallen short of required CAPA
  • Manage CAPA responsibilities to build successful investigation procedures
  • Avoiding the five most common CAPA-related audit observations
    • Inadequate — did not sufficiently address root cause
    • Inappropriate — did not address root cause
    • Not corrective action, but preventive action
    • Not clearly defined
    • Not completed in the timeframe identified
  • Recognize how CAPA increases the effectiveness of an investigation
  • Interactive Exercise: Develop a preventive action plan with a real scenario customized to manage and deploy required procedures.
2:30 p.m. – 2:45 p.m. 


2:45 p.m. – 4:30 p.m.

Writing Useful Investigation Reports That Employees and Management Understand and Can Put Into Practice

  • Deploying the six-step process for report writing: capture thoughts, organize, create a draft, peer review, update draft and route for review/approval
  • Understanding formatting guidelines for numbers — use numbers to show sequence, chronology, data and series information
  • Understanding how to use figures for measurements, percentages and statistics
  • Basic rules for writing effective reports
    • Paragraphs should be limited to seven sentences
    • Sentences limited to 15 to 20 words
    • No more than seven bullets per heading
    • Use n/a in blank spaces within columns
  • How to properly use “assure” vs “ensure”
  • Interactive Exercise: Attendees, in small groups will create an investigative report and report back to all attendees. They will also present their next steps.
4:30 p.m. – 5:00 p.m.

The Final Investigation Package

  • What are the regulatory expectations that must be included in the final investigation package? • What should the final investigation package consist of in order to avoid regulatory action?
  • Tips to assure the final package is self-explanatory and stands on its own • How including a table of contents can improve readability and use
  • Ideas for organizing supporting documentation that must be included with the final package
5:00 p.m.