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Expertise at Your Fingertips: Virtual & On Demand Conferences Connecting You with Regulators & Industry Thought Leaders Just Published: ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls Online Live Training Courses in Sept. on Industry-Critical Topics Feature 3 September 2020 | Video Commissioning and Qualification FAQs Why is commissioning & qualification important? Is qualification the same as verification? What is a key factor when implementing a risk management approach to commissioning and qualification? What is a common... 01 September, 2020 | iSpeak Blog Learn How Key Pharma Manufacturers & Suppliers are Dealing with Supply Chain Issues Ensuring supply of critical medicines during the COVID-19 pandemic has been a severe challenge and tested the limits of the pharmaceutical industry. Join us virtually, along... 31 August 2020 | Video 2020 ISPE Europe Annual Conference Teaser Talks: Pharma 4.0™ - Managing the COVID-19 Crisis The 2020 ISPE Europe Annual Conference has been reimagined into an interactive virtual experience that will immerse you in crucial conversations inside the industry, with the business partners and regulators associated... Calendar Of Events 17 September, 2020 | Affiliate/Chapter Women In Pharma: Establish Your Stance & Credibility in the Workplace ISPE New Jersey Chapter’s Women in Pharma® invite you to our 2020 Virtual Event Establish Your Stance & Credibility in the Workplace Join other ISPE industry professionals for... 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 3 September 2020 | Video Commissioning and Qualification FAQs Why is commissioning & qualification important? Is qualification the same as verification? What is a key factor when implementing a risk management approach to commissioning and qualification? What is a common... 31 August 2020 | Video 2020 ISPE Europe Annual Conference Teaser Talks: Pharma 4.0™ - Managing the COVID-19 Crisis The 2020 ISPE Europe Annual Conference has been reimagined into an interactive virtual experience that will immerse you in crucial conversations inside the industry, with the business partners and regulators associated... 21 August 2020 | Video 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference: Impact of COVID-19 The 2020 ISPE Asia Pacific Pharma Manufacturing Virtual Conference & Executive Forum has been reimagined into a virtual experience that will immerse attendees in actionable, interactive discussions around strategies to... Guidance Documents See More Documents Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls Published August 2020 This guide provide a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations. Read Full Description 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 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 Technology Trends: The Transition to Digitalization Pharmaceutical Engineering Magazine In the pharmaceutical industry, digitalization involves developing and implementing digital technologies at all levels of pharmaceutical operations. The aim is to transform the industry by capturing, analyzing, and using vast amounts of data collected from... 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 ×...