| SUNDAY, November 9, 2008 |
| Time |
Event |
| 7:00 AM - 5:00 PM |
Sunday Activities |
| 11:00 AM - 6:00 PM |
Registration Open |
| 6:00 AM - 6:30 PM |
First Timer's Orientation |
| 6:30 AM - 9:30 PM |
Welcome Reception |
| |
| MONDAY, November 10, 2008 |
| Time |
Event |
Lab Area |
Exhibit Area |
| 7:00 AM - 8:00 AM |
Continental Breakfast |
Closed |
Closed |
| 8:00 AM - 8:30 AM |
Welcome |
Closed |
Closed |
| 8:30 AM - 10:00 AM |
Keynote Speaker — Bruce Jenner |
Closed |
Closed |
| 10:00 AM - 10:15 AM |
Break |
Closed |
Closed |
| 10:15 AM - 12:00 PM |
Product Roadmap & Sneak Peak Demos |
Closed |
Closed |
| 10:00 PM - 1:15 PM |
Lunch |
Open |
Open |
| |
| |
Hall 1
Business/Industry Trends |
Hall 2
Best Practices
Case Studies |
Hall 3
Technology Innovation |
|
|
| 1:15 PM - 2:15 PM |
Slim Down with Lean Quality - Best Practices on Process, Resources and Automation |
Tips & Tricks in implementing SmartAudit in a global Pharmaceutical Co. - Novo Nordisk |
Paving the Way to eMDRs - Pilgrim |
Open |
Open |
| 2:15 PM - 3:15 PM |
Supporting New Trends & Controls for Supplier Quality with SmartSolve- Nikki Willett |
Case Study -
Stryker Biotech |
SmartEngineer - Engineering Collaboration for 3D Models. Demo included. - Pilgrim |
Open |
Open |
| |
| 3:15 PM - 3:30 PM |
Break |
Open |
Open |
| |
| 3:30 PM - 4:30 PM |
Applying Risk Management across the Product and Operational Value Chain |
Q&MIS to SmartSolve Migration - Air Liquide |
SmartSolve Forms Designer and Introducing SmartDesigner - Pilgrim |
Open |
Open |
| 4:30 PM - 6:00 PM |
FDA Regulated SIG Group |
Manufacturing SIG Group |
World Wide Blood Forum |
Closed |
Closed |
| |
| 6:30 PM - 7:30 PM |
Cocktails on the Waterfront |
| 7:30 PM - 10:30 PM |
Dinner and Party |
| |
| TUESDAY, November 11, 2008 |
| Time |
Event |
Lab Area |
Exhibit Area |
| 7:30 AM - 9:00 AM |
Continental Breakfast |
Closed |
Closed |
| |
| |
Hall 1
Business/Industry Trends |
Hall 2
Best Practices
Case Studies |
Hall 3
Technology Innovation |
|
|
| 8:00 AM - 9:00 AM |
Workshop -
Rights & Rights Groups Training |
Workshop -
Risk-Based Validation Pack Training |
Workshop -
Setting up for eMDR Submission Training |
Closed |
Closed |
| 9:00 AM - 10:00 AM |
Environmental Health & Safety - Going Green |
The Power of SmartSolve for FDA Design Controls Case Study - Osmetech |
SmartConnector for SAP and Oracle |
Open |
Open |
| |
| 10:00 AM - 10:30 AM |
Break |
Open |
Open |
| |
| 10:30 AM - 11:30 AM |
How Does Industry Prepare for FDA Inspection? - GxP Associates |
Case Study - Millipore |
Receiving and In-Process Inspections - Introducing SmartInspect. Demo included. - Pilgrim |
Open |
Open |
| 11:30 AM - 12:30 AM |
Global Auditing Practices |
Supplier Quality Case Study - Medtronic ERS |
Technical Optimization & Tuning SmartSolve for Best Performance. - Pilgrim |
Open |
Open |
| |
| 12:30 AM - 1:30 PM |
Lunch in Downstairs Indoor/Outdoor Dining Area |
Open |
Open |
| |
| 1:30 PM - 2:30 PM |
Quality and Outsourcing |
Case Study - TBD |
SmartDoc & Regulatory Submissions - Pilgrim |
Open |
Open |
| 2:30 PM - 3:30 PM |
Nightmare of Managing Product Recalls -
Pre-Event Planning |
QAD ERP System to Pilgrim Integration (Osmetech Case Study) - QAD |
eLearning & SCORM Integration with SmartTrain. Demo included. - Pilgrim |
Open |
Open |
| |
| 3:30 PM - 3:45 PM |
Break |
Open |
Open |
| |
| 3:45 PM - 4:45 PM |
Workshop -
Using SmartDoc folders training |
Workshop -
Q&MIS 8 New Features training |
Workshop -
Using Forms Designer on Existing SmartSolve Forms training |
Closed |
Open |
| |
| 4:45 PM - on |
Free Night |
Closed |
Closed |
| |
| WEDNESDAY, November 12, 2008 |
| Time |
Event |
Lab Area |
Exhibit Area |
| 7:00 AM - 8:30 AM |
Continental Breakfast |
Closed |
Closed |
| |
| |
Hall 1
Business/Industry Trends |
Hall 2
Best Practices
Case Studies |
Hall 3
Technology Innovation |
|
|
| 7:30 AM - 8:30 AM |
Workshop -
Using SmartDesigner to Create New Forms training |
Workshop -
Setting up Translation Manager for Local Orgs training |
Workshop -
Risk-Based Validation Pack training (repeat) |
Closed |
Closed |
| 8:30 AM - 9:30 AM |
Quality Performance - Measuring ROI and Cost of Quality |
Case Study - TBD |
SSA Family of Integration Products (ICM, MSA, CSA) - Pilgrim |
Open |
Open |
| 9:30 AM - 10:30 AM |
Product Liability and Good Documentation Practices |
Case Study - Irish Blood |
Visualizing your Pilgrim Data (sneak peak SmartPulse). Demo included. -Pilgrim |
Open |
Open |
| |
| 10:30 AM - 10:45 AM |
Break |
Open |
Open |
| |
| 10:45 AM - 11:45 AM |
Update in FDA Trends |
Case Study - TBD |
SmartSolve Introducing SmartDesigner (repeat) |
Open |
Open |
| |
| 11:45 AM - 12:15 PM |
Pick up Lunch-to-Go |
Closed |
Closed |
| |
| 12:15 PM - 1:00 PM |
Ask Pilgrim Executives Panel |
Closed |
Closed |
| 1:00 PM - 2:30 PM |
Closing Remarks |
Closed |
Closed |
Please Note:
Schedule is as of 7/21/08 and is subject to change. Check back for updates. |
