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 email@example.com TEL 949.275.1148 . We look forward to seeing you at the seminar.
Pages to are hidden for
"Seminar Announcement - Download as DOC"Please download to view full document