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Event Information
Conference: September 20 - 24, 2010 · Exhibition: September 21-23, 2010 ·
Document Title
Raw Materials / Supply Chain
Raw Materials / Supply Chain
- Agenda overview: Go to the agenda overview to view the detailed agenda for each track or symposium.
- To view the complete agenda: Please download the PDF brochure.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
7:00
Registration and Coffee
Raw Materials/Supply Chain
Point Counterpoint Session:
Integrating Raw Materials and Suppliers into a Pharmaceutical Quality System
8:00
Co-Chairpersons' Remarks:
Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc.
Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec
Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc.
Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec
8:05
Risk Assessment and Management for Raw Materials
A holistic risk assessment approach is described, including supplier capabilities, quality systems, and material safety data. In addition, an assessment of material properties on the process, which links parameters to critical quality attributes, is required. The information required is significant but the outputs can result in a clearer prioritization of the data required, more rational setting of specifications, avoidance of redundant testing and a better foundation for continuous improvement.
Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc.
A holistic risk assessment approach is described, including supplier capabilities, quality systems, and material safety data. In addition, an assessment of material properties on the process, which links parameters to critical quality attributes, is required. The information required is significant but the outputs can result in a clearer prioritization of the data required, more rational setting of specifications, avoidance of redundant testing and a better foundation for continuous improvement.
Duncan Low, Ph.D., Scientific Executive Director, Process Development, Amgen, Inc.
8:30
Supply Chain Risk Management Methodologies
Using case studies, this talk will demonstrate the usefulness of applying an analytical driven sourcing methodology to mitigate risks within a company's supply chain. In addition, this talk will address Biogen Idec's approach to ensure objectives of assurance of product supply, product quality and financial compliance within the supply chain through a instituting a decentralized GMP sourcing model. Issues like organizational approaches, governance structures, sourcing tools and risk management techniques will be discussed.
Joydeep Ganguly, Associate Director, Manufacturing Sciences, Biogen Idec
Using case studies, this talk will demonstrate the usefulness of applying an analytical driven sourcing methodology to mitigate risks within a company's supply chain. In addition, this talk will address Biogen Idec's approach to ensure objectives of assurance of product supply, product quality and financial compliance within the supply chain through a instituting a decentralized GMP sourcing model. Issues like organizational approaches, governance structures, sourcing tools and risk management techniques will be discussed.
Joydeep Ganguly, Associate Director, Manufacturing Sciences, Biogen Idec
8:55
Global Adventitious Agent Regulations of Raw Materials Used in Biopharmaceutical Manufacturing
Abstract unavailable at press date.
Barbara Potts, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.
Co-author: T.W. Tanaka
Abstract unavailable at press date.
Barbara Potts, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.
Co-author: T.W. Tanaka
New, Unpublished Data
9:20
Case
Study
Supplier Perspective on Risk Assessment and Management of Critical Raw Materials for the Manufacture of Biological TherapeuticsStudy
The pharmaceutical market is requiring greater characterization and transparency of the supply chain for critical raw materials used in manufacturing due to the continuing need to minimize variability and increased regulatory oversight. This presentation will focus on techniques for characterization and a case study on how these techniques improved our understanding of the solubility of these components to enhance the consistency of the manufacturing process.
David Kolwyck, Technical Manager, SAFC, a division of Sigma Aldrich
9:45
Networking Refreshment Break in Exhibit and Poster Hall
Sponsored by
10:30
Implementing a Raw Materials/Supplier Management Risk Mitigation Strategy with Limited Resources
- What do you do after you assess the risks?
- What can you use to compensate for identified risks-- short term and long term?
- Tactics for small firms
- Leveraging information
10:55
New Applications of Analytical Methodologies for Raw Material Characterization
Abstract not available at press date.
Maureen Lanan, Ph.D., Principal Scientist, Analytical Development, Biogen Idec
Abstract not available at press date.
Maureen Lanan, Ph.D., Principal Scientist, Analytical Development, Biogen Idec
11:20
Audience Interactive Panel Discussion with All Session Presenters
12:30
Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their posters for discussion.
Poster presenters are requested to stand by their posters for discussion.
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