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Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe, firstname.lastname@example.org.
Pharmaceutical manufacturing is evolving as the industry adopts the science- and risk-based approach inherent in FDA’s quality-by-design (QbD) initiative.
Pharmaceutical manufacturing is evolving as the industry adopts the science- and risk-based approach inherent in FDA’s quality-by-design (QbD) initiative. QbD has raised the bar in augmenting process understanding to ensure consistent product quality, and equipment manufacturers, ingredient suppliers, and manufacturers are responding with innovation in their products and services.
Shows such as INTERPHEX 2013 enable attendees to come together to share scientific innovation and discuss the trends and topics affecting the industry. One such topic is the QbD initiative and its impact on the pharmaceutical industry. Pharmaceutical Technology is hosting a panel discussion on implementing QbD during the INTERPHEX sessions, taking place Wednesday, April 24, at 10:15 am. Manufacturing Editor Jennifer Markarian will be moderating a special panel featuring Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co.; Chris Moreton, vice-president pharmaceutical sciences at FinnBrit Consulting; and Jonathon Thompson, technical sales consulting supervisor at Invensys. The panel 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 will also discuss the benefits and challenges of QbD implementation.
Another topic that continually impacts the industry is outsourcing. Jim Miller, a member of Pharmaceutical Technology’s Editorial Advisory Board and regular Outsourcing Outlook columnist, will present Wednesday’s Keynote Address on Recalibrating the Pharmaceutical Services Opportunity. Don’t miss Jim’s discussion on the implications of the changing bio/pharmaceutical R&D model for contract service providers.
Bringing suppliers and pharmaceutical/biopharmaceutical companies together is the focus on the Pharmaceutical Technology/BioPharm International Marketplace, a new Advanstar and Dun & Bradstreet Credibility Corp. Online Marketplace Community, which connects buyers and sellers with the information and insights they need to collaborate and make purchasing decisions. The Marketplace further delivers valuable information through the Pharmaceutical Sciences, Manufacturing, & Marketplace Report, a biweekly newsletter that reports on the latest technical developments in five main communities: solid dosage, semisolid, and specialty dosage forms; parenterals; pharmaceutical analysis; chemical API manufacturing; and biologic API manufacturing. We welcome you to stop by the PharmTech booth (Booth #4139) to learn more.
We hope you find everything you are looking for at this year’s INTERPHEX, and that you will join Pharmaceutical Technology in the years to come in discussing the topics and innovations that shape the industry.
Pharmaceutical Technology and BioPharm International