MasterControl’s Santos-Serrao to Speak on What Clinical Can Learn from the Manufacturing GMP Industry about Quality & Compliance
SALT LAKE CITY, UT, UNITED STATES - Apr 6, 2017 - Patricia Santos-Serrao, RAC, director of clinical and regulatory solutions of MasterControl Inc., will speak at the 8th Proactive GCP Compliance Conference on April 6 in Philadelphia. She will focus on a topic of increasing importance to the global pharmaceutical industry, how good manufacturing practices (GMP) can be effectively implemented to achieve good clinical practices (GCP).
Even though at a high-level glance, manufacturing and clinical settings would not appear to be similar, the principles behind GMP and GCP are fundamentally similar because their overarching goal is to refine processes to ensure quality in compliance to regulatory guidelines, said Santos-Serrao. By embedding quality oversight practices into clinical trials, organizations can improve their ability to manage deviations, implement corrective actions, incorporate preventative actions, and provide adequate training to ensure adequate oversight over study sites, investigators, and vendors.
During the presentation, Santos-Serrao will examine how to evaluate vendor auditing approaches and how they can be used in GCP and incorporating GMP methodologies for identifying deviations and assigning risk levels, as well as applying those methodologies to protocol review. She will also provide information on designing a training approach that focuses on high-risk areas and on GMP CAPA methodology and applying similar processes to GCP CAPA operations.
Santo-Serrao is scheduled to present at 10:30 a.m. on the first day of the main conference in the Sonesta Philadelphia Rittenhouse Square at 1800 Market Street. Information about MasterControl and its wide array of quality and compliance management solutions is available at www.mastercontrol.com Additional information about the Proactive GCP Compliance Conference is available at http://exlevents.com/proactive-gcp-compliance/.
About MasterControl
MasterControl Inc. produces enterprise software solutions that enable life science and other regulated companies to deliver life-improving products to more people sooner. MasterControls integrated solutions securely manage a company's critical information throughout the entire product lifecycle while reducing overall costs and increasing internal efficiencies. More than 1,000 companies worldwide ranging from five employees to tens of thousands use MasterControls suite of scalable cloud solutions for document management, quality management, electronic batch record management, supplier management, and clinical and regulatory information management. MasterControl solutions are known for being easy to implement, easy to validate and easy to use. For more information, visit www.mastercontrol.com.