3D Tissue Models
Regulatory Audits & Inspections
San Diego Marriott La Jolla
4240 La Jolla Village Drive, La Jolla
California, USA

Schedule of Presentations:

Monday, December 10, 2007
07:45:00 Registration and Breakfast
08:45:00 Chairperson’s Welcome and Opening Remarks
09:00:00 Auditing Vendors For Regulated Computer System Rich Poser
12:00:00 Luncheon
13:00:00 Successful Management Of An FDA Inspection: Before, During And After Kristen Grumet
15:00:00 Afternoon Break And Refreshments
15:15:00 Essential Quality Agreements In The Inspection And Management Of CMOS (Contract Manufacturing Organizations) James Nelson
16:00:00 Qualification And Inspection Of Laboratory Instruments & Equipment Rich Poser
17:00:00 Update From The PDA’s Standard Audit Criteria Task Force Peter J. Miller
17:15:00 Interactive Panel Discussion Rich Poser, Kristen Grumet, James Nelson, Peter J. Miller
17:45:00 End Of Day One
Tuesday, December 11, 2007
07:30:00 Breakfast
08:25:00 Chairperson’s Opening Remarks
08:30:00 Auditing Techniques To Determine Compliance Risks John Shaeffer
10:15:00 Experiences From Computer System Validation Auditing And Common Problems
11:00:00 Mid-morning Break
11:15:00 Exploring The Do’s And Don’ts When Being Audited Virgina L. Corbin
12:00:00 Luncheon
13:00:00 Auditing Software Vendors David Nettleton
14:30:00 Break And Refreshments
14:45:00 How To Prepare For A Vendor Audit Virgina L. Corbin
16:15:00 How To Care And Maintain An Effective Supplier Audit Program Peter J. Miller
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