Outsourcing Manufacturing of Biopharmaceuticals 2012

Outsourcing manufacturing, once used mainly as a cost-reduction or capacity supplement strategy, is now increasingly being viewed as a risk-mitigation for operational excellence and growth strategy. Ensuring consistent quality and reliable delivery require companies to understand their vendors' and contractors' areas of expertise, have good control over their supply chain networks, and have a solid risk-management strategy in place. This conference will bring these critical elements together and offer case studies on strategies that will lead toward a successful agent-sponsor relationship, thereby ensuring consistent high quality products from your CMO partners.

Topics to be covered in 2012:

-FDA and EMEA's view on Sponsors' Responsibilities for Quality Oversight
-Risk-based Approaches to Outsourcing and Technology Transfer
-QbD, ICH and Process Validation Concepts in Technology Transfer
-Scaling up in Technology Transfer from Disposables to Stainless Steel
-CMOs' Handling and Prevention of Cross-Contamination
-Raw Material / Supply Chain Network Management
-Agent-Sponsor Relations
-Outsourcing for Specialized Expertise/Technology/Formulation
-Functional vs. Integrated Service Model for Outsourcing of Biopharmaceuticals Manufacturing
-Unique Process and Analytical Transfer Case Studies
-Small Companies' Perspectives on Challenges in Outsourcing Biomanufacturing
-Outsourcing to Emerging Markets
-Control of IP during Technology Transfer to External Party
-Compare and Contract Outsourcing & Transfer of Clinical Manufacturing, Commercial Manufacturing, and Fill/Finish Operations