Course Description:

One of the most common FDA 483 and Warning Letter citations is for inadequate deviation investigations. As FDA continues to cite inadequate investigations, it is critically important to conduct investigations to determine what happened, why it happened, and what was done to prevent the issue from re-occurring. In order to meet these goals, investigators must employ critical thinking skills for investigations. This seminar will help personnel involved in deviation investigations to understand and successfully apply fundamental deviation investigation steps and best practices. The key areas of focus will include:

  • Product containment / impact considerations
  • Fact / evidence gathering
  • Deducing the correct root cause
  • CAPA

A few primary takeaways from the course:

  • This practical, how-to course will provide participants with skills they can immediately apply to investigations within their own organizations.
  • Group exercises will allow participants to practice skill sets with feedback from the instructor.
  • The seminar will conclude with participants conducting a complete mock deviation investigation, including authoring an investigation report.

Learning Objectives:

On completing this course on FDA compliance, participants will be able to:

  • Understand regulatory requirements and FDA expectations for deviation investigations, root cause, CAPAs, and effectiveness checks
  • Understand the purpose of deviation investigations, root cause analysis, CAPAs, and effectiveness checks
  • Identify what is / is not a deviation event requiring investigation
  • Properly describe a deviation event
  • Identify immediate containment actions
  • Conduct an immediate impact assessment
  • Develop a comprehensive deviation investigation outline
  • Conduct objective, evidence-based investigations
  • Utilize good evidence gathering and interview techniques
  • Properly evaluate investigation findings
  • Differentiate between isolated events and systemic issues
  • Use root cause analysis tools to determine correct root cause
  • Develop appropriate CAPAs / effectiveness checks
  • Develop an investigation report
  • Avoid pitfalls during the investigation process

Who Will Benefit :

This course is designed from a pharmaceutical manufacturing perspective; however, since the main focus is on techniques and practices, the course material may be equally applied to biologics and medical device environments. It will benefit:

  • Deviation investigators
  • Reviewers and approvers of deviation investigation reports (e.g. deptartment heads)
  • Deviation system owners
  • Production staff / management
  • QA staff / management
  • QC staff / management
  • Regulatory affairs staff / management

Topic Background:

In 2013, inadequate investigations were the second most common 483 citation. Deviation investigations receive detailed scrutiny during FDA inspections, and FDA uses investigation reports and trends to identify potential quality problems in all areas of the company. A single inadequate investigation may lead to significant negative events, including release of sub-standard product or product recall. A pattern of inadequate investigations may require costly and time-consuming system remediation efforts.

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Regulatory Requirements
  2. FDA Inspection Expectations / Warning Letter Examples
  3. Purpose of Deviation Investigations
  4. Deviation Investigation Process Model
    1. 5 Part Process Model
    2. Key Terms and Definitions
  5. Key Investigation Principles
    1. Process / System Knowledge
    2. Objective Facts / Evidence
    3. Avoiding Investigation Bias
    4. Team Investigations
  6. Identification of Deviations
    1. What is a Deviation / Deviation Types
    2. Identifying Deviations
    3. Describing Deviations
  7. Immediate Containment / Immediate Impact Assessment
    1. Immediate Containment Considerations
    2. Potentially Impacted Lots
    3. Immediate Impact Assessment Considerations
    4. Historical Trend Review
  8. Investigation Outline
    1. Background / Baseline Information
    2. To-Do List
    3. Investigative Pathways
  9. Source Documents / Physical Evidence
    1. Gathering Physical Evidence and Documents
  10. Interviews
    1. Interview Techniques and Role Play
  11. Evaluating Investigation Findings
    1. Physical Evidence, Documents, Interviews
    2. Isolated Events vs. Systemic Issues

  1. Determining Root Cause
    1. What is Root Cause / Root Cause Analysis
    2. Root Cause Analysis Tools
    3. Performing Root Cause Analysis
    4. Group Exercise - Fishbone Diagram
  2. Determining CAPAs
    1. Purpose of a CAPA
    2. Corrective vs. Preventive Actions
    3. Developing CAPAs
    4. Effectiveness Checks
    5. Group Exercise - CAPAs and Effectiveness Checks
  3. Final Investigation Report
    1. Purpose of an Investigation Report
    2. Key Investigation Report Elements
  4. Putting it All Together: A System Viewpoint
  5. Deviation Investigation Workshop
    1. Participant Teams to Conduct Mock Investigation and Determine Root Cause/CAPAs, Based on Case Studies Provided by Trainer

Meet Your Instructor

Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance

Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of deviation - CAPA, change control, GMP auditing, GMP training, and regulatory inspection preparation and management.

Working with large and small companies, Mr. Campbell has successfully developed, remediated and implemented key quality systems. He is a skilled GMP auditor, and has audited multiple API, drug product, packaging, testing, and distribution facilities. He is an experienced GMP trainer, and has developed customized and interactive training presentations for many companies. He has also provided FDA inspection support for several clients, including readiness training, on-site assistance during inspections, and authoring written responses to inspectional observations. Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as director of quality systems.

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