PDA/FDA Pharmaceutical Supply Chain Conference 2013

Building on earlier PDA-cosponsored conferences and workshops on pharmaceutical supply chains, the 2013 PDA/FDA Pharmaceutical Supply Chain Workshop will explore how various sectors of the regulated industry have adapted to the emerging global culture; address the benefits of modernization and innovation as well as the ongoing challenges of supplier (CMOs, ingredients) management.

This workshop will also provide a forum to further implementation of innovative approaches aiming to prevent illicit acts such as counterfeiting, diversion and economic adulteration from threatening the safety of the drug supply as well as provide an overview of Contract Manufacturing from a variety of perspectives: The contract giver, the contract provider and an independent third party viewpoint. Sessions will discuss the challenges clients and CMOs face within the pharmaceutical and biopharmaceutical industry as well as provide thought-provoking case studies on common CMO-based questions about regulatory expectations, corporate responsibility and sub-suppliers.

Learning Objectives

By participating in the two day conference, participants will gain current knowledge from industry and regulatory experts and be able to:

• Provide insights gained from global regulatory, health, and trade organizations that are actively trying to solve pharmaceutical supply chain issues.

• Explain the common challenges the industry faces in ensuring supply chain integrity in the pharmaceutical ingredient and drug product supply chains.

• Evaluate existing supply chain management practices.

• Evaluate methods to enhance supplier quality management including supplier selection and qualification processes, as well as on-going monitoring and management.

• Evaluate approaches and emerging technologies used to improve supply chain distribution controls for incoming materials and components.

• Benchmark and learn about best practices with pharmac