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Connecting Pharmaceutical Knowledge Menu Join/Renew Login Store Search Main navigation Conferences & Training Conferences Upcoming On Demand Training On Demand Online Live Custom Onsiteor clicking on "OK", you consent to the use of cookies . Expertise at Your Fingertips: Virtual & On Demand Conferences Connecting You with Regulators & Industry Thought Leaders Just Published: ISPE Good Practice Guide: Critical Utilities GMP Compliance Register for Upcoming Pharma Best Practices Webinars Feature 30 July 2020 | Video ISPE Women in Pharma® ISPE Women in Pharma® provides women in the pharmaceutical industry professional training and education to foster mentorship and networking for women and ethnically diverse people, to drive their successful career... 16 July 2020 | Video ISPE Good Practice Guide: Critical Utilities GMP Compliance Regulatory compliance of critical utilities is essential to maintaining overall facility compliance. Due to their hidden nature, critical utilities can become vulnerable to non-compliance and significantly increase the... 15 July, 2020 | iSpeak Blog Read, Learn, Innovate: Top Blog Posts from June 2020 Featured in this edition of iSpeak Reading Roundup, are the top blog posts from June 2020. Discover key insights for cleaning validation practices, risk-based approaches to... Calendar Of Events 29 July, 202029 | Classroom Training Oral Solid Dosage Manufacturing Process Training Course This training course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses... 01 September, 20201 | Classroom Training Pharma Water Generation USP WFI & Purified Water Training Course This course will cover the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the... 21 September, 202021 | Classroom Training Cleaning Validation Principles Training Course This course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning... Videos 30 July 2020 | Video ISPE Women in Pharma® ISPE Women in Pharma® provides women in the pharmaceutical industry professional training and education to foster mentorship and networking for women and ethnically diverse people, to drive their successful career... 16 July 2020 | Video ISPE Good Practice Guide: Critical Utilities GMP Compliance Regulatory compliance of critical utilities is essential to maintaining overall facility compliance. Due to their hidden nature, critical utilities can become vulnerable to non-compliance and significantly increase the... 6 May 2020 | Video 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference Teaser Talks: Pharma 4.0® The 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference is a two-day, fully interactive digital event that delivers all of the comprehensive learning opportunities from ISPE’s in-person Biomanufacturing... Guidance Documents See More Documents Good Practice Guide: Critical Utilities GMP Compliance Good Practice Guide: Critical Utilities GMP Compliance Published June 2020 The goal of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It is to help pharmaceutical organizations achieve and maintain their critical utility systems in a state of control, and then be able to efficiently demonstrate their systems’ Good Manufacturing Practice (GMP) compliance to regulatory inspectors and auditors. Read Full Description Good Practice Guide: HVAC & Process Equipment Air Filters Good Practice Guide: HVAC & Process Equipment Air Filters Published December 2019 The ISPE Good Practice Guide: HVAC and Process Equipment Air Filters aims to be a valuable reference on the selection, application, specification, testing, and operation and maintenance of filters in the pharmaceutical industry. This Guide is intended to be used as supplement to the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC), providing detailed information into the subject of air filters in HVAC and process equipment applications. Read Full Description Good Practice Guide: Asset Management Good Practice Guide: Asset Management Published November 2019 The ISPE Good Practice Guide: Asset Management provides practical guidance for establishing an asset management system that enables organizations to realize increased value from their assets, both physical and non-physical. This Guide identifies best practices in strategic asset management as outlined in the ISO 55000 series of standards. An effective asset management system translates the organization’s objectives into asset-related decisions, plans, and activities using a risk-based approach. This Guide provides recommendations, examples, and resources to help organizations in the development or improvement of their asset management system. Read Full Description Baseline Guide Vol 4: Water & Steam Systems 3rd Edition Baseline Guide Vol 4: Water & Steam Systems 3rd Edition Published September 2019 The ISPE Baseline Guide® Water and Steam Systems (Third Edition) aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. It is intended to help meet Good Manufacturing Practices (GMPs) and comply with regulations and related guidance. Read Full Description See More Documents COVID-19 Resources for Pharma Industry We recognize that the ever-changing nature of this novel virus is concerning and is requiring many of us to adjust our standard practices. Still, we want to assure you that ISPE is here to support your knowledge and connectivity needs. View Resources 2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology Pharmaceutical Engineering Magazine For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the... Read Full Article View Current Issue Not a Member Yet? Whether networking at events or collaborating through our Communities of Practice, the value of an ISPE membership is in the connections made between pharmaceutical industry professionals and Regulators to collaborate on solutions to common goals and challenges. Join Today Member Benefits Copyright © 2020 ISPE | International Society for Pharmaceutical Engineering Footer menu Contact Us FAQs Media Kit Terms of Use Privacy Policy Site Map Facebook Linkedin Twitter Youtube Mail2...