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					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
        improvement.
    • 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
            – Basics
            – Inspection Logistics and Tactics
            – FDA Profiles, Culture and Interview Techniques
            – Recent 483 Trends
            – EU vs. US GMP Regulations
    •   10:00 – 12:00 Inspection Readiness
            – Template
            – Inputs / Data Collection
            – Scoring
            – Risk Prioritization
            – Pareto Analysis
            – Metrics
            – 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

Date

    
                          th
        Wednesday, May 7 , 2008

Location

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)
                                                              st
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:

       E-mail jim.anthony@enterey.com
       TEL 949.275.1148
.
We look forward to seeing you at the seminar.