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INTERPHEX 2013 to be held April 23–25, 2013, at the Javits Center in New York will highlight pharmaceutical regulation QA/QC, product development, facility, process design, manufacturing, packaging, and supply chain programs.
The INTERPHEX Conference Program, to be held Apr. 23–25, 2013, at the Javits Center in New York, New York, has been developed to span the pharmaceutical manufacturing life cycle. The conference tracks and accompanying sessions have been configured to reflect the project team environment firms use to usher products from development to commercial distribution, according to a Feb. 26, 2013, INTERPHEX press release.
The conference will feature a variety of programs from quality-by-design and process analytical technology tutorials to sound development of a design space. Industry thought leaders will provide insight from a variety of arenas including academia, consulting, and pharmaceutical manufacturing. All functional areas are addressed in five comprehensive session tracks: regulatory QA/QC, product development, facility and process design, manufacturing and packaging, and supply chain.
Pharmaceutical Technology will host two sessions. In a keynote address, Jim Miller, President, PharmSource Information Services, Inc. will discuss forces shaping the contract services industry in “Recalibrating the Pharmaceutical Services Opportunity”, scheduled for Wednesday, Apr. 24, at 9 am. In a panel discussion, “Lessons Learned: Successes and Challenges In Implementing Quality By Design,” manufacturing and regulatory experts will share their insight and practical experience in implementing QbD, including strategies for defining a design space, adaption of manufacturing processes, the feasibility for real-time release testing, and the keys to continuous process verification. The panel is scheduled for Wednesday, Apr. 24, at 10:15 am.
Other sessions include “Current Continuous Process Validation Program (CCVP) Following FDA Current Guidelines,” presented by Victor Hernandez, EMD Millipore, which will review how firms are frantically backfilling knowledge in order to maintain products throughout their lifecycle. Additionally, Robert Dream's session entitled “Biopharma’s Flexible Imperative” will discuss the new model biopharmaceutical facility, one far less rigid than earlier prototypes. Dream, from HDR Company LLC, will discuss external influences on the new flexible model, including the timely role of biodefense.
In other keynote sessions, Congressman Bill Cassidy’s, MD, (R-LA) presentation, “Policy Recommendations for Improving Patient Access to Drugs in Shortage,” will touch upon potential improvements to the current reimbursement system to avoid future drug shortages and Dr Rajesh Nair, president, Indegene will discuss “Reorganizing for the Future: Succeeding in the New Pharmaceutical Industry.”
Rounding out INTERPHEX’s educational component will be a series of Exhibit Hall Technology Floor Tours: OSD Technologies, Advanced Aseptic Technologies, Biomanufacturing Technologies, and Modular Construction Technologies. Tours will offer critical insights followed by a walking tour to select vendors showcasing the latest technology and equipment on the show floor.