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Recently I was “asked” to help co-chair the 2016 Facilities of the Future Conference by a not-to-be-named board member who has my same first name.  I accepted the assignment despite the minimal pay (none) and countless hours of effort required for one...
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In a recent ISPEAK blog concerning electronic records (e-records) integrity1, Mark Newton discussed the e-records integrity concerns associated with in transit between infrastructures. Eventually, e-records in transit are warehoused in a device such as a...
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On Sunday, June 5, 2016, 85 pharmaceutical industry professionals gathered for ISPE’s first Data Integrity Workshop, held in held in conjunction with the 2016 ISPE/FDA/PQRI Quality Manufacturing Conference, 6–8 June 2016, in North Bethesda, Maryland....
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The evening of 7 June marked ISPE’s 12th Annual Facility of the Year Awards (FOYA) Banquet in Bethesda, MD where ISPE and guests gathered to honor the accomplishments of six category and three honorable mention winning companies in this year’s FOYA...
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Conrad Mutschler, Vice President, Global Supply Chain Strategy, Perrigo Company plc, opened the first Manufacturing and Operational Excellence education session on June 8, 2016, at the ISPE/FDA/PQRI Quality Manufacturing Conference on June 6, 2016.  The...
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Advancing the Validation Lifecycle Approach Register now for the ISPE/PQRI Process Validation Conference on 24 – 26 October. For the past three years, this conference has offered a much needed professional development opportunity for individuals who...
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Dr. Michael Kopcha, Director, Office of Pharmaceutical Quality, CDER, FDA, delivered the keynote address on the second day of the ISPE/FDA/PQRI Quality Manufacturing Conference, June 7, 2016. Dr. Kopcha presented an overview and update on FDA’s Office...
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The 2016 Pharma EXPO, a joint venture of ISPE and PMMI, will take place 6 – 9 November at the McCormick Place Center, in Chicago, Illinois.  Held in conjunction with the Pharma EXPO is the Pharma EXPO Conference.  This conference is a three-day,...
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The 2016 ISPE Annual Meeting & Expo promises to deliver endless opportunities to increase your knowledge and expand your network. How? It's all in the numbers... Save up to $200 on Your Exhibit by Booking before 27 June 2016 Interact with more...
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Lynne Krummen, Vice President and Head, Pharma Technical Development, Genentech Inc., delivered the second keynote at the opening session of the ISPE/FDA/PQRI Quality Manufacturing Conference, 6 June 2016: “Biotechnology: Past, Present, and Future.”...
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General: In reference to groups addressing quality manufacturing: “You guys (ISPE) are way in the forefront on quality manufacturing”. Dr. Doug Throckmorton, MD, Deputy Center Director for Regulatory Programs, FDA/CDER Noted similarities between the...
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According to a new survey by the Pew Research Center, 73 percent of adults consider themselves lifelong learners. One would think this percentage would be even higher as in today’s fast-paced world, there’s so much creation and advancement every day....
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Dr. Dara Corrigan, FDA’s Associate Commissioner for Global Regulatory Policy in the Office of Global Regulatory Operations and Policy, delivered the first of two keynote addresses at the opening session of the ISPE/FDA/PQRI Quality Manufacturing...
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This article was published in the May/June 2016 edition of Pharmaceutical Engineering® Magazine. A continuous collaborative effort is critical to the delivery of a well-designed pharmaceutical facility. One of the best ways to create this collaboration...
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Frontiers in Manufacturing Science and Quality: Cutting-Edge Developments and Futuristic Products, was the third Emerging Technologies session on June 7, 2016, at the ISPE/FDA/PQRI Quality Manufacturing Conference. Moderator Sau (Larry) Lee opened the...
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It’s time for another edition of the Reading Roundup featuring the top blog posts from May 2016.  Grab your favorite cup of coffee, kick back and catch-up on what the pharmaceutical industry was reading in May. FDA Data Integrity Draft Guidance –...