Best Practices

1
FDA Regulatory and Compliance Symposium Managing
Risks From Pipeline to Patient August 24-26,
2005
Best Practices Internal Compliance
Auditing Larry Gibbons
2
Using a Risk/Benefit Model

• Utilizing a RISK-BASED Schedule
• Understanding the Current REGULATORY FOCUS
• Ensuring COMPETENT Audit Teams
• Creating EXCITEMENT in the Job
• Analyzing Internal and External Findings using
  EQUIVALENT categorization
• Ensuring Corrective ACTION
• MEASURING and Reporting on Success
• Ensuring ISSUE AWARENESS at Senior Management
  Levels

3
Using a Risk/Benefit Model

• Utilizing a RISK-BASED Schedule by focusing on
  facilities/operations
• responsible for higher risk products or products
  with reports of serious adverse events
• with recent significant or repetitive regulatory
  observations
• responsible for single source product
• responsible for large profit product

4
Understanding the Current REGULATORY FOCUS

• Utilize regulatory and industry sources to
  identify top regulatory concerns
• Review FOI available warning letters, recalls,
  etc. for repetitive issues
• Analyze FDA adverse event databases for top
  product issues being reported
• Subscribe to organizations that provide
  regulatory environment analyses

5
Understanding the Current REGULATORY FOCUS
6
Ensuring COMPETENT Audit Teams

• Establish competency requirements
• Establish required experience
• Measure qualifications and competencies by
• Qualification
• Certification
• Create excitement in the job

7
Creating EXCITEMENT in the Job

• Provide unique opportunities (for example)
• An opportunity to audit interesting projects
  (Instead of just processes)
• Six Sigma training
• The challenge to assess the value added in a
  process/project in addition to compliance

8
Analyzing Internal and External Findings

• Utilizing EQUIVALENT categorization
• Critical, Major, Minor categories established
  against defined criteria
• Compare internal findings with regulatory
  findings
• Identify and communicate trends

9
Ensuring Corrective ACTION

• Provide recommendations to auditees
• Be actively involved in overseeing/reviewing/appro
  ving action plans
• Assess the adequacy of actions taken during next
  audit cycle

10
Measuring and Reporting on Success

• Expectations
• Reduction in critical findings
• General shift in findings from critical/major to
  major/minor
• Overall reduction in regulatory findings
  correlated to internal analysis
• Quarterly Reports
• Audits performed and measurements to expectations

11
Ensure ISSUE AWARENESS at Senior Management
Levels

• DO NOT spin the facts to produce the most
  favorable scenario
• Management needs to KNOW and UNDERSTAND the
  issues
• Management at the highest levels of the
  organization needs to be current on the issues at
  least quarterly

12
Summary / Review

• Utilizing a RISK-BASED Schedule
• Understanding the Current REGULATORY FOCUS
• Ensuring COMPETENT Audit Teams
• Creating EXCITEMENT in the Job
• Analyzing Internal and External Findings using
  EQUIVALENT categorization
• Ensuring Corrective ACTION
• MEASURING and Reporting on Success
• Ensuring ISSUE AWARENESS at Senior Management
  Levels

13
Discussion