iSpeak Blog
Congratulations to Prof. Christoph Herwig, PhD, Christian Wölbeling, and Thomas Zimmer, PhD—authors of the 2017 Article of the Year. Their article "A Holistic Approach to Production Control: From Industry 4.0 to Pharma 4.0" as published in the May-June...
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It’s time for another edition of Reading Roundup featuring the top blog posts of December 2017. Start off your week by catching up on what the pharmaceutical industry was reading in December. FDA, Data Integrity, and the Dreaded Twenty-Five Words “Your...
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ISPE’S Member of the Year Award was established in honor of Max Seales Yonker, an active member, leader, and contributor to ISPE and to the industry. When ISPE lost this bright spirit to cancer in 2005, we honored her memory with an award that...
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Christine M. V. Moore, PhD, Global Head and Executive Director, Merck & Co., led “Changes in the Regulatory Landscape,” an education session held 31 October during the 2017 ISPE Annual Meeting & Expo. The first speaker, Ellen F. Morrison, Assistant...
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As co-chairs of the Barrier Track program at the 2018 ISPE Aseptic Conference, Michael Faia and I built this year’s program around real-world case studies from an all-star line-up of leading sterile manufacturers including:  Biogen Bristol Meyers...
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ISPE announced its full technical program and keynote speakers for the 2018 ISPE Aseptic Conference taking place 6 - 7 March in Reston, Virginia. The following keynote addresses will showcase industry leaders offering compelling and enlightening...
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ISPE announced its keynote speakers and full technical program for their 2018 Facilities of the Future Conference, taking place 20–22 February in Bethesda, Maryland USA. Returning for the first time since the launch event in 2016, this event will explore...
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The annual ISPE Aseptic Conference continues to provide cutting-edge education in aseptic technology. The 2018 ISPE Aseptic Conference, 6 -7 March in Reston, VA, marks 27 years of providing information to ensure safe and reliable product supply while...
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Joe Robinson, QCxP, CPIP Regional Manager, Midwest Region CAI Where did you go to college/university and what was your major? (and if it wasn’t...
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  One of the first education sessions at the recent 2017 ISPE Annual Meeting & Expo in San Diego, California, was “Aligning System Validation and Data Lifecycles,” held Sunday afternoon, 29 October, even before the opening keynote was...
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The European Commission has chosen Amsterdam as the new host of the European Medicines Agency (EMA) headquarters. The city was awarded the coveted prize after it won a coin toss with Milan, which received the same number of votes after three rounds of...
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As global regulators sharpen their focus on data integrity, issues have emerged around practices observed in operations that generate data used to make drug product decisions.  One such practice is “testing into compliance”-- repeatedly analyzing a...
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It’s time for another edition of Reading Roundup featuring the top blog posts of October 2017. Start off your week by catching up on what the pharmaceutical industry was reading in October. The New Normal - Pharmaceutical Engineering Magazine...
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It may have been Halloween, and some participants may have been in costume, but the membership breakfast Tuesday morning for Day 3 of the 2017 ISPE Annual Meeting & Expo was all about receiving treats rather than playing tricks. The hallmark of each...
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DAY 2 WRAP UP! Incoming Board of Directors Chair Timothy Howard, Vice President, Commissioning Agents, Inc., opened day two of the 2017 ISPE Annual Meeting & Expo by thanking delegates for their attendance. “Whether this is your first annual meeting...
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Greetings from San Diego! “America’s Finest City” welcomed some 1,600 attendees, including 255 delegates from 34 countries from outside the United States, to the 2017 ISPE Annual Meeting & Expo at the San Diego Marriott Marquis & Marina on 29 October. ...
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Know Before You Go! Conference Essentials Explore the Conference Program Travel Tips Hotel Dining Options Registration and Information Hours Saturday, 28 October | 1300–1800 Sunday, 29 October | 0700–1800 Monday, 30 October | 0700–1800 Tuesday,...