November 7 – 10, 2011
Chapter One: Quality System & Regulatory Requirements Throughout Product Life Cycle – from Discovery to Commercialization
Pepperdine University: Westlake Village Campus
Schedule of Classes
Click here for regular prices
| Mon. Nov 7 to Nov 10. |
9:00 am – 4:00 pm |
Full week of Classes $500 |
| Mon. Nov 7 | 9:00 – 12:00 |
Quality System for Start-up Companies (Development to Early Phase) and Quality System Overview (Phase 3 to Commercial) |
| Mon. Nov 7 | 1:00 – 3:00pm | Implementing a Robust Quality System and Vendor and Supplier Qualification Program $92.50 |
| Mon. Nov 7 | 9:00 – 12:00 | Product Life Cycle from Discovery to Commercialization $92.50 |
| Mon. Nov 7 | 1:00 – 3:00 |
Risk Assessment |
| Tues Nov 8 | 9:00 – 12:00 | Avoid Communication Pitfalls that Sabotage Quality & Regulatory Goals $92.50 |
| Tues Nov 8 | 1:00 – 3:30 | Theory of Mind and Prioritizing Your Business Through Focused Awareness $92.50 |
| Tues Nov 8 | 9:00 – 12:00 | Welfare in Biomedical Research $185.00 |
| Tues Nov 8 | 1:00 – 4:00 | Auditing Animal Facilities and Writing an Animal Research Protocol $92.50 |
| Wed Nov 9 | 9:00 – 12:00 | US Food and Drug Administration (FDA) Inspections $92.50 |
| Wed Nov 9 | 1:00 – 4:00 | Current Good Manufacturing Practice (CGMP) Audits: How to Prepare for US-FDA (Foreign) CGMP Inspections $92.50 |
| Thurs Nov 10 | 9:00 – 12:00 | Project Management for Quality Organization $92.50 |
| Thurs Nov 10 | 9:00 – 12:00 | Contract Facility (CMO/CTO) Management $92.50 |
| Thurs Nov 10 | 9:00 – 12:00 |
What is New in FDA |
