1. and Compliance Symposium
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/approving 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