ISPE Updates and Expands Guidance for Testing of GxP SystemsEnsure sufficient test coverage starting with a correct scope of testing
Mon, 01/21/2013 - 10:09
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a leading authority on best practices for the pharmaceutical industry, has issued updated and expanded guidance to help pharmaceutical companies maximize testing… ISPE Releases New Guidance for Designing and Constructing PACLAW FacilitiesThe industry’s only guidance of this type for PACLAW facilities
Thu, 07/05/2012 - 12:46
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) has released its new guidance relating to the design, construction, and commissioning and qualification of packaging, labeling, and warehousing (PACLAW) facilities… ISPE and FDA Discussed Strengthening Safety at Joint CGMP ConferenceConference addressed how tools are being applied to mitigating risks and manage global supply chains
Tue, 06/12/2012 - 12:35
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) just concluded its two-day current good manufacturing practices (CGMP) conference, which was co-sponsored by the U.S. Food and Drug Administration (FDA). Held June… ISPE Releases New Book in Pharmaceutical Quality Life Cycle Series<em>Change Management System as a Key Element of a Pharmaceutical Quality System</em>
Wed, 06/06/2012 - 11:47
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) has released the latest volume in the Product Quality Lifecycle Implementation (PQLI) series, Change Management System as a Key Element of a Pharmaceutical Quality… ISPE, ILF Engage with U.S. and Asian RegulatorsTwo meetings focused on top industry concerns for pharmaceutical professionals and groups
Mon, 05/21/2012 - 13:01
(ISPE: Tampa, FL) – The International Society for Pharmaceutical Engineering (ISPE) continued its mission to provide a neutral ground for pharmaceutical industry professionals and regulators to discuss industry issues at ISPE affiliate meetings in… Global Regulators and Pharma Execs Speak at FDA-ISPE CGMP ConferenceSpeakers focus on global quality, worldwide compliance, and the future vision of the pharmaceutical industry
Wed, 04/18/2012 - 11:26
(ISPE: Tampa, FL) — The International Society for Pharmaceutical Engineering (ISPE), which provides an educational forum for the pharmaceutical industry, has brought together a substantial lineup of global regulatory officials and pharmaceutical… Current Good Manufacturing Practices ConferenceCo-sponsored by ISPE and FDA, June 4–5, 2012, in Baltimore
Thu, 03/15/2012 - 12:38
(ISPE: Tampa, FL) -- The Food and Drug Administration (FDA) has joined with the International Society for Pharmaceutical Engineering (ISPE) to deliver an integrated learning conference focused on industry and regulatory viewpoints concerning current… ISPE Issues Guidance for Clinical Trials Comparator ManagementPharmaceutical industry resource for product sourcing and blinding
Tue, 03/06/2012 - 13:20
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a society for professionals involved in the engineering and manufacture of pharmaceuticals and related products, has issued industry guidance to advise clinical… ISPE Supports Pharmaceutical Industry with Guide for Project ManagementSpecific tools and techniques to integrate regulatory compliance with the project life cycle
Thu, 01/19/2012 - 16:02
(ISPE: Tampa, FL) – The International Society for Pharmaceutical Engineering (ISPE) has released a new industry guidance document, Project Management for the Pharmaceutical Industry. This guide is the first document of its type to discuss and… ISPE Expands Commissioning and Qualification Guidance Series New guide bridges gap between Baseline Guide and full ICH Q8, Q9, Q10 adaptation
Mon, 12/12/2011 - 09:15
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global nonprofit association of 22,000 pharmaceutical science and manufacturing professionals, has released a new guidance document on pharmaceutical…
