Achieving Raw-Material Transparency in the Pharmaceutical/ Biopharmaceutical Supply Chain
Event Date: June 18, 2013 at 11:00 AM EDT
As regulatory demand increases on biopharmaceutical manufacturers to ensure the quality of the raw materials used for the manufacture of drug substances and formulation of finished drug products, these same demands filter back to suppliers. This 60-minute webcast will examine industry practice and use of regulatory guidance (FDA, EU, and ICH) for developing operational control and quality processes for mitigating risk in the pharmaceutical/biopharmaceutical supply chain. Learn from industry experts how to resolve the challenges toward achieving supply-chain transparency and its management as an ongoing concern.

This webcast will feature supplier and customer strategies and systems approach for the supply-chain transparency of critical raw materials supplied for use in regulated applications:
• Providing sustainable control on both sides of the supply chain
• Knowing the cost to minimizing risk (or not)
• Meaningful documentation

Key Learning Objectives:

• Discover what is critical to gain supply chain transparency for raw materials.

• Understand challenges in addressing risk mitigation.

• Learn to identify critical requirements when seeking to balance between cost and security as a drug moves through the pipeline from research to commercialization

Moderator:

Patricia Van Arnum

Executive Director
Pharmaceutical Technology

Speakers:

Daniel Matlis

President,
Axendia

Wes Schmidt
Divisional Vice President
AbbVie Operations Quality Assurance

Tom Beil
Vice President of Quality and Regulatory Affairs
Sigma-Aldrich


IMPORTANT - PLEASE READ
This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Sara Barschdorf, sbarschdorf@advanstar.com.

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