Quality Focus: Ensuring Raw Material Transparency

Quality is of utmost importance in drug development and manufacturing. The increased globalization of the pharmaceutical and biopharmaceutical industries, resulting in more complex and elongated supply chains on a raw material and ingredients basis, obligates suppliers and pharmaceutical and biopharmaceutical companies to develop ways to achieve greater transparency and understanding of those supply chains to ensure product quality and regulatory compliance. 

Pharmaceutical Technology will examine these issues in a educational webcast, Achieving Raw-Material Transparency in the Pharmaceutical/ Biopharmaceutical Supply Chain, live on Tuesday June 18 from 11:00 AM to 12:00 PM EST. This 60-minute webcast will examine industry practice and the use of regulatory guidance (FDA, EU, and ICH) for developing operational control and quality processes for mitigating risk in the pharmaceutical/biopharmaceutical supply chain. Industry experts will share ways, from both a supplier and pharmaceutical/biopharmaceutical company perspective, on ways to resolve the challenges toward achieving supply-chain transparency and its management. The webcast will feature supplier and customer strategies and a systems approach for the supply-chain transparency of critical raw materials supplied for use in regulated applications.

The panelists for the webcast include: Wes Schmidt, Divisional Vice-President of AbbVie Operations Quality Assurance; Tom Beil, Vice-President of Quality and Regulatory Affairs, Sigma-Aldrich/SAFC; and Daniel Matlis, president of Axendia. The panelists will share insight into identifying what is critical to gain supply-chain transparency for raw materials; understanding challenges in risk mitigation; and learning how to identify critical requirements when seeking to balance between cost and security as a drug moves through the pipeline from research to commercialization.

Audience members will be able to ask the panelists questions for additional insight during the live webcast on Tuesday June 18 from 11:00 AM to 12:00 PM EST. Additional information on the webcast, including how to register for the live event and on-demand viewing may be found here.