Managing and Reducing Drug and Device GxP Deviations

DAY ONE

8:30 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 10:00 a.m.

• 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.

Lunch

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. 

Break

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.

Session Wrap-up

DAY TWO

Continental Breakfast

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

Break

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?

Lunch

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.

Break

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.

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

Adjourn