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Contract Manufacturing Resource Center

Outsourcing Excellence in China and India
Close collaboration effectively manages far-flung partnerships

Managing Contract Partners: Risk Management
In this program you will learn how to apply the best QbD and risk management practices to ensure compliance, patient safety and corporate reputation.

On-Demand Webcast: Managing Contract Partners: The Heat is On
In this program Hedley Rees discusses best practices in world-class contractor management and procurement, and how they can be woven into the fabric of your organization.

Managing Contract Partners: Do We Have a Failure to Communicate?
Are you managing your contract partners, or are they managing you?

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White Papers: In Depth Research

Ensuring a Streamlined Approach for Nasal Spray Product Development & Manufacturing
Author: DPT Laboratories
Posted: 07/18/2012
This white paper aims to provide a comprehensive overview of the CMC guidance by the U.S. Food and Drug Administration and present a streamlined approach for development and manufacture of nasal spray products. It will focus on the ability of the spray device to deliver reproducible plumes and uniform dose content.

Product & Process Transfer of a Low Solubility Compound with 6 year OTIF > 95%
Author: Alkermes, Inc.
Posted: 06/20/2012
This case study demonstrates the successful transfer of a low solubility compound into one of our manufacturing sites and achieving as a result, an OTIF (On-Time-InFull) consistently over 95%.

Case Study: Five Year Trouble Free Manufacturing for Large Pharma Company
Author: Alkermes, Inc.
Posted: 06/20/2012
This case study demonstrates a large pharmaceutical contract manufacturing engagement in which there has been five years trouble free supply with OTIF (On-Time-InFull) consistently >95%.

Pharmaceutical Outsourcing: Success Factors in Long-term Strategic Partnerships
Author: Alkermes, Inc.
Posted: 06/19/2012
Outsourcing is no longer a tactical decision but rather a partner-driven strategic activity. This paper presents essential success factors in fostering and maintaining long-term partnerships in pharmaceutical outsourcing. After completing the registration form you will have access to download the white paper in pdf format.

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