1-Day Seminar Announcement
Inspection Readiness – Assessing Your Site’s State of Inspection Readiness
How Prepared Are You for an FDA Inspection?
How do you currently assess your site’s state of inspection readiness?
What metrics do you use?
Do you know your risks?
How do you prioritize your risks?
What are your plans to defend or mitigate your risks?
This one day (full day) seminar will:
• Provide you with a tool to consistently and effectively identify, prioritize, track, measure
and mitigate inspection risks as part of an on-going inspection readiness program.
• Ensure your continued focus on compliance, risk prioritization and continuous
• Supply you with recommendations, templates, checklists and tools to:
• Begin implementation of an Inspection Readiness Program at your site.
• Increase your level of inspection preparedness.
• Improve your efficiency during an inspection.
Agenda / Schedule
• 8:00 – 9:00 AM Registration and Continental Breakfast
• 9:00 – 10:00 AM Inspection Overview
– Inspection Logistics and Tactics
– FDA Profiles, Culture and Interview Techniques
– Recent 483 Trends
– EU vs. US GMP Regulations
• 10:00 – 12:00 Inspection Readiness
– Inputs / Data Collection
– Risk Prioritization
– Pareto Analysis
– Continuous Improvement
• 12:00 – 1:00 PM Lunch
• 1:00 – 2:00 PM Using the Template: Group Exercises
• 2:00 – 3:00 PM Additional Tools and Recommendations
• 3:00 – 3:30 PM Action Plan and Checklists for Your Next Inspection
• 3:30 – 4:00 PM Closing Remarks
Hosts / Speakers
1. Mike Ferletic
President / Consultant / Enterey, Inc.
13 years of biotech and pharmaceutical experience
2. Jim Anthony
Senior Manager / Consultant / Enterey, Inc.
11 years of medical device, pharmaceutical and biotech experience
Wednesday, May 7 , 2008
Holiday Inn Express Hotel and Suites
34280 Pacific Coast Highway
Dana Point, CA 92629
Registration / Cost
$249 per person
$225 per person (2 or more attending from the same company)
Register on-line at our website www.enterey.com after March 31 or if you have additional
questions or comments, please e-mail or call us at:
We look forward to seeing you at the seminar.