These two discussions will be instrumental in educating leading pharma and biotech manufacturing teams about the systems that can be put in place to achieve better process understanding and predictability and ultimately grow their bottom lines
LAFAYETTE, Colo. (PRWEB) October 28, 2008
Neway will present "Achieving the Goals of QbD and Process Analytical Technology (PAT) – Bridging the Gap between Process Development and Manufacturing" at the University of Heidelberg's PAT Conference Oct. 28-30 in Heidelberg, Germany, organized by the European Compliance Academy (ECA). The presentation will reveal how manufacturers can achieve the "Desired State" of manufacturing through Quality by Design (QbD) saving both time and money by early design of processes with reduced variability and lower tech transfer risk. Highlights include how to undertake Design Space Development, Design for Manufacturing and PAT to achieve manufacturing process excellence using the principles of QbD.
Rothman will present "Leveraging Process Intelligence for Product Lifecycle Management" at the WBF (The Forum for Automation and Manufacturing Professionals) European Conference Nov. 10-12 in Barcelona, Spain. He will address how to bridge the gap between IT and Manufacturing teams and the advantages gained by both through collaborative implementation of Manufacturing Intelligence software.
"These two discussions will be instrumental in educating leading pharma and biotech manufacturing teams about the systems that can be put in place to achieve better process understanding and predictability and ultimately grow their bottom lines," said Aegis' President and Chief Executive Officer, Robert Di Scipio.
Founded in 1999, the ECA is an independent organization chaired by a Scientific Advisory Board with 10 members of the pharmaceutical industry and regulatory authorities. With nearly 3,600 members, ECA has become the leading European association with regard to pharmaceutical Quality Assurance and GMP compliance. The members from all over Europe and abroad represent close to 60 countries. The ECA Advisory Board represents European regulatory authorities as well as the pharmaceutical and biopharmaceutical industry. By their voluntary work, the board members support ECA in fulfilling its mission to impart most relevant knowledge on the interpretation and implementation of GMP and regulatory requirements. More information is available at http://www.gmp-compliance.org and http://www.pat-conference.org.
WBF provides an open forum for the exchange of information related to the management, operation, and automation of manufacturing processes. Created in 1994, members of the non-profit, professional organization include end-users, vendors, consultants and academics. WBF provides organization, management, and structure to facilitate networking among its members and sharing of knowledge and information related to manufacturing processes. WBF documents best practices and guidelines for implementation of standards that apply to batch control and the exchange of batch data, as well as conducting technical conferences and technical training programs. WBF is a charter member of The Automation Federation (http://www.automationfederation.org). More information about WBF is available at http://www.wbf.org.
Aegis Analytical Corporation provides the only fully integrated manufacturing data management software system that enables life sciences companies to accelerate products to the market, improve operating efficiencies and Quality by Design initiatives, and satisfy regulatory obligations. More than just a manufacturing data warehouse, data historian or dashboard, Aegis' Discoverant software solution presents a complete view of the manufacturing process from raw materials to finished product to provide on-demand data access integrated with user-centric investigational analytics and reporting capabilities for all data types. To learn more about Discoverant, visit: http://www.aegiscorp.com.