ISPE Blog - News and information from the International Society for Pharmaceutical Engineering http://blog.ispe.org News and information related to the International Society for Pharmaceutical Engineering and the pharmaceutical manufacturing industry. Mon, 16 Nov 2009 17:50:51 +0000 http://wordpress.org/?v=abc en hourly 1 OSD Forms Baseline Guide, 2nd Edition Released at ISPE Annual Meeting http://blog.ispe.org/?p=370 http://blog.ispe.org/?p=370#comments Mon, 16 Nov 2009 17:50:51 +0000 Marni Schribman http://blog.ispe.org/?p=370 ISPE has released Oral Solid Dosage (OSD) Forms Baseline Guide, Second Edition, at its annual meeting in San Diego this week. The FDA-reviewed publication updates content from the original work to current industry standards, practices, and regulatory requirements.

Read more on the FiercePharmaManufacturing web site…

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]]> http://blog.ispe.org/?feed=rss2&p=370 CMC-Biotech Working Group Consortium Unveils A-Mab Case Study at ISPE Annual Meeting http://blog.ispe.org/?p=366 http://blog.ispe.org/?p=366#comments Tue, 27 Oct 2009 14:05:31 +0000 Marni Schribman http://blog.ispe.org/?p=366 ISPE has announced a major extension of its Product Quality Lifecycle Implementation® initiative (PQLI®) further into biotechnology. This significant development comes after the decision of the CMC-Biotech Working Group consortium to provide their A-Mab case study to ISPE. The public availability of the final version of this case study will be announced during the PQLI session at the ISPE 2009 Annual Meeting.   Read more…

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]]> http://blog.ispe.org/?feed=rss2&p=366 Preview. Post. Participate. http://blog.ispe.org/?p=363 http://blog.ispe.org/?p=363#comments Mon, 26 Oct 2009 18:10:32 +0000 Marni Schribman http://blog.ispe.org/?p=363 Now you can get event-related updates, post your thoughts, preview exciting gatherings, and experience everything that is the 2009 ISPE Annual Meeting. Stay connected during the before, during, and after the event by…

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]]> http://blog.ispe.org/?feed=rss2&p=363 ISPE Adjusts Online Learning Pricing Structure to Provide Greater Value and Meet Global Economies http://blog.ispe.org/?p=358 http://blog.ispe.org/?p=358#comments Thu, 22 Oct 2009 15:35:45 +0000 Marni Schribman http://blog.ispe.org/?p=358 “ISPE is sensitive to the fact that current economic conditions around the world make it difficult for pharmaceutical manufacturing professionals to obtain the knowledge and training they require,” said ISPE President and CEO Robert P. Best. Read more…

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]]> http://blog.ispe.org/?feed=rss2&p=358 ISPE Announces 2009-2010 Board of Directors Election Results http://blog.ispe.org/?p=355 http://blog.ispe.org/?p=355#comments Fri, 09 Oct 2009 12:13:53 +0000 Marni Schribman http://blog.ispe.org/?p=355 “I’m very pleased with the diverse composition of our incoming Board of Directors,” said ISPE President and CEO Bob Best. “ISPE’s Members can only benefit from the myriad of backgrounds represented by our incoming Board in terms of geography, areas of interest, and areas of expertise.” Read more…

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]]> http://blog.ispe.org/?feed=rss2&p=355 New ISPE GMP Online Course Now Available http://blog.ispe.org/?p=350 http://blog.ispe.org/?p=350#comments Wed, 07 Oct 2009 19:35:52 +0000 Marni Schribman http://blog.ispe.org/?p=350 GMP: USFDA GMP Inspection Approach for Quality Systems
This highly-interactive, pre-recorded online course reviews the quality system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. Quality system elements reviewed include: annual product reviews, compliant files, discrepancies and failure investigations, change control, reprocessing, returns/salvages, stability testing, quarantine systems, and validation/verification.

Click here for more information and to purchase the course from ISPE’s Online Store.

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]]> http://blog.ispe.org/?feed=rss2&p=350 ISPE 2010 Tampa Conference http://blog.ispe.org/?p=344 http://blog.ispe.org/?p=344#comments Mon, 05 Oct 2009 19:53:27 +0000 Marni Schribman http://blog.ispe.org/?p=344 Registration for the ISPE 2010 Tampa Conference  is now open. Location and preliminary seminar information is already posted and will be updated daily. Let’s all start thinking about new learning opportunities and new prospects for 2010!

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]]> http://blog.ispe.org/?feed=rss2&p=344 The Latest ISPE News Tidbits On Twitter… http://blog.ispe.org/?p=338 http://blog.ispe.org/?p=338#comments Tue, 22 Sep 2009 17:49:46 +0000 Marni Schribman http://blog.ispe.org/?p=338 Pharma professionals invited to network poolside at ISPE 2009 Annual Meeting COP Night Reception — http://bit.ly/2rvrIx.

Go to ISPE’s Twitter page or search #ISPEAM09 for more great Society announcements.

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]]> http://blog.ispe.org/?feed=rss2&p=338 “Thank you for this great opportunity to participate in the Maintenance Excellence webinar…” http://blog.ispe.org/?p=334 http://blog.ispe.org/?p=334#comments Mon, 21 Sep 2009 15:42:55 +0000 Marni Schribman http://blog.ispe.org/?p=334 “Thank you for this great opportunity to participate in the Maintenance Excellence webinar.  Although I have many years of experience in maintenance and engineering, the subject matter and presentation provided a much needed benchmark. I look forward to receiving the slides and will purchase the presentation for our maintenance library when it becomes available.”  — Director of Operations & Facilities at RTI-Biologics, Inc.

Click here for more information about ISPE’s Online Learning opportunities.

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]]> http://blog.ispe.org/?feed=rss2&p=334 ISPE Adds Five More Sessions to Annual Meeting Education Line-up http://blog.ispe.org/?p=322 http://blog.ispe.org/?p=322#comments Tue, 15 Sep 2009 17:08:54 +0000 Marni Schribman http://blog.ispe.org/?p=322 ISPE has added five more sessions to the 40+ already planned for its 2009 Annual Meeting being held 8-11 November in San Diego, California, USA. The five new courses are:

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