When: 8:30 am – 1:30 pm, Wednesday, April 6, 2005
Where: VWR Scientific Products | 3745 Bayshore Blvd., #D, Brisbane, CA 94005 map and directions

Who Should Attend: Members of the Management and Operations team in a start-up company will benefit from this workshop. This session is of particular interest to those in the areas of quality assurance, program management, purchasing, legal, and finance.

The scope of this workshop applies to all types of services that a bio-start-up company can use (e.g., API sourcing, clinical trials execution, human resources, lab supplies, legal, methods development, product manufacturing, project management, quality systems, toxicology, etc.).

Three key topics will be addressed as presentations and in breakout sessions where participant can work through a situation facing their company:

Due Diligence in Selecting Vendors (e.g., defining needs and objectives; narrowing list to possible few; confidentiality; site visit planning & execution; comparing options). Presented by Paula Mendenhall, Pharm D., Senior Vice President of Operations, DURECT Corporation. Entrepreneur Perspective by Michael K. Eckstut, Vice President of Business Operations, Life Sciences for Conformia Software, Inc.

Quality Agreements to Establish Deliverables (e.g., evaluating quality system of vendor; defining project/product specifications; what does success look like; what are penalties/recourse for non-delivery). Presented by Lewis Michaels, Sr. Director of Compliance at Peninsula Pharmaceuticals, Inc.

Project Management to Control the Process (e.g., determine appropriate degree of tracking based on project maturity, what key activities to track; tying budget items to key activities; how to communicate to team). Presented by Chad M. Nikel, MBA, PMP, Senior Project Manager at Integrated Project Management Company, Inc. Entrepreneur Perspective by Jennifer Lorenzen, Executive Director, Development Programs, Corcept.

Program participants will be served lunch, followed by an opportunity to tour VWR Distribution Center.

Pre-registration: $60 BayBio Members | $75 non-Members. Available on-line through April 4, 2005.
Walk-in registration: April 6, starting 7:30am is $80 for BayBio Members | $90 for non-Members.
All sales are final - BayBio offers no refunds.


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