DAY ONE
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8:30 a.m. – 9:00 a.m.
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Registration and Continental Breakfast
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9:00 a.m. – 10:00 a.m.
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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
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10:00 a.m. – 10:15 a.m.
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Break |
10:15 a.m. – 11:00 a.m.
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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
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11:00 a.m. – 12:00 p.m.
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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.
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12:00 p.m. – 1:00 p.m.
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Lunch
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1:00 p.m. – 2:30 p.m.
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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
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2:30 p.m. – 2:45 p.m.
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Break
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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.
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5:00 p.m. |
Session Wrap-up
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DAY TWO
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8:30 a.m. – 9:00 a.m. |
Continental Breakfast
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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
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10:45 a.m. – 11:00 a.m. |
Break
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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?
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12:00 p.m. – 1:00 p.m. |
Lunch
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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.
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2:30 p.m. – 2:45 p.m. |
Break
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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.
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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
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5:00 p.m. |
Adjourn
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