Course Agenda
Day 1

8:00 – 8:30 AM: Registration

8:30 – 10:00AM: Lecture 1: The Inspection Process
  • Systems and traditional inspection approaches
  • Managing the process
  • Establishing clear SOPs and Policies
  • Interacting with FDA inspectors
  • Common 483s and warnings
 
10:00 – 10:15AM: Break

10:15 – 12:00 noon: Lecture 2: Case Study of a Manufacturing Facility Inspection
  • FDA inspection questions
  • Documentation
  • CAPA: corrective and preventive actions
  • ‘Out of Specification’ prevention and response

12:00 – 12:45PM: Lunch

12:45 – 2:15PM: Lecture 3: Legal Concerns
  • Executive responsibility and vulnerability
  • Management review
  • Staff training and liabilities
  • FDA authority and powers
  • FDA audit limitations

2:15 – 2:30AM: Break

2:30 – 3:30PM: Lecture 4: FDA Inspection Checklist: Do’s and Don’ts
  • Documentation preparations
  • Hosting investigators
  • What not to say, what not to do: Do’s and dont’s
  • Key roles and players in an audit
  • Responses to the inspections
 
Day 2

8:30 – 10:00AM: Lecture 5: Emerging Issues
  • Part 11 signatures and records: latest interpretation, 483s
  • QbD product development and design: latest interpretation, 483s
  • Special device issues
  • Other emerging 483 issues
 
10:00 – 10:15AM: Break

10:15 – 12:00 noon: Lecture 6: Follow-up to an Audit
  • Managing the bad news: notifications, news releases and social media tools
  • Responding to 483s
  • CAPA and process control
  • Audit finding appeal process and dispute resolution
  • Dealing with Warning letters, injunctions and Alerts

12:00 – 12:45PM: Lunch

12:45 – 2:15PM: Lecture 7: Uses and Limitations of Internal Audits
  • Fear factor
  • Inside versus outside
  • Checklist
  • Internal audit reports
  • A model for FDA inspections