FDA Organization and Enforcement

• FDA Strategy and Organization
• The Law and Regulations
• Formal Enforcement Tools
• Informal Enforcement Tools

Latest FDA Issues and Initiatives

• Top 5 Warning Letters
• Top 10 Drug 483's
• Top 10 Device 483's
• FDA Initiatives and Changes

Management Responsibility - Latest Expectations

• Executive Vulnerability
• Organization
• Training
• Audits
• Management Reviews

Corrective & Preventive Action (CAPA) - Latest Expectations

• New Definitions
• Non-conformances Versus Deviations
• Expected Elements Of CAPA System

GMP Documents & Documentation Requirements

• Types and Controls
• Problem Areas
• Change Control Problems
• Quality Records Review

Out Of Specification (OOS) - Latest Expectations

• Scope of OOS
• Laboratory Investigation
• Production Investigation
• Copy of OOS Guideline
• Sample Warning Letters

Part 11 Elec. Signature/Records - Latest Expectations

• Current Focus
• Warning Letter Issues

• Product Development Regulations
• Most Frequent observations
• Documentation Expectations

QSIT - Current FDA Inspection Approach

• What QSIT Is
• How QSIT Works

Complaint Handling - Your 1^st Line Of Defense

• Aspects Inspected
• Records Requirements
• Tracking and Trending

FDA Inspection Do's and Don'ts

• Procedure For Inspection Accommodation
• Records Readiness
• Who To Include/Not Include
• What To Say/Not To Say

Addressing a 483

• Developing Initial Response
• Timeliness Of Response
• How To Challenge/Dispute A 483

Why Internal Audit Systems Fail

• The Pass/Fail Criteria
• Auditor Versus Verifier
• Auditor Fear Factors
• Inadequate Auditor Accountability
• Ineffective Audit Schedule/Plan