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By using our site or clicking on "OK", you consent to the use of cookies . Upcoming Events Register for Live & On Demand Pharma Best Practice Webinars ISPE Best of Pharma Series - Available NOW Feature 06 May, 2021 | News & Press Releases ISPE Convenes Regulators and Industry to Discuss Challenges & Solutions for Quality Risk Management ISPE will convene regulators and industry leaders from around the world at the 2021 ISPE Global Pharmaceutical Regulatory Summit on 16 June and at the 2021 ISPE Asia Pacific... 04 May, 2021 | iSpeak Blog ISPE Member Spotlight - Alice Redmond, PhD You are an active and engaged ISPE Member! You sit on the ISPE Board of Directors, the ISPE Foundation Board, and the Steering Committee of Women in Pharma®. Can you share... 01 May, 2021 | Sponsored Content Implementing Continued Process Verification with Bio4C™ ProcessPad Continued Process Verification (CPV) is the lengthiest and most data heavy phase of process validation. It requires continuous monitoring of processes against defined limits... Calendar Of Events 17 May, 202117 | Classroom Training Quality Management Systems Training Course Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to... 22 June, 202122 | Classroom Training Pharma Facilities Project Management Training Course Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project... 28 June, 202128 | Classroom Training GMP Fundamentals for the Pharmaceutical Industry This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European... Videos 29 April 2021 | Video 503B Compounding Pharmacies: Principles, GMPs and Case Studies Join us on 6 May 2021 for the FREE live webinar "503B Compounding Pharmacies: Principles, GMPs, and Case Studies" to take an in-depth look at how this field has developed since section 503B was created as part of the... 27 April 2021 | Video Introducing the 2021 FOYA Category Winners Technology and innovation in the pharmaceutical industry are more critical now than ever before as healthcare worldwide is straining from the COVID-19 pandemic. Even in these trying times, it is important to spotlight... 26 April 2021 | Video What Are Some Critical Elements to Ensure Full Transparency between Industry & Regulatory Agencies? The global pharmaceutical industry continues to face unexpected challenges in responding to the world’s pandemic. The impact on normal operations has been felt in companies of all sizes, with varying manufacturing... Guidance Documents See More Documents Good Practice Guide: Maintenance 2nd Edition Good Practice Guide: Maintenance 2nd Edition Published January 2021 Maintenance can impact both the quality of products and the compliance of pharmaceutical processes. Maintenance programs have long been recognized as critical to the success of the operations they support. Read Full Description Good Practice Guide: Equipment Reliability Good Practice Guide: Equipment Reliability Published December 2020 Equipment reliability is concerned with the risk of failures in equipment and processes, providing focus on equipment availability, fitness for purpose, and cost. The strategy and tactics of reliability contribute to realizing the value of equipment throughout its useful life and mission. Read Full Description APQ Guide: Corrective Action & Preventive Action (CAPA) System APQ Guide: Corrective Action & Preventive Action (CAPA) System Published November 2020 The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System provides a quality management framework for assessing and advancing CAPA system maturity level by evaluating several key components. Read Full Description GAMP RDI Good Practice Guide: Data Integrity by Design GAMP RDI Good Practice Guide: Data Integrity by Design Published October 2020 This ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity. Read Full Description See More Documents New Eurasian Economic Union (Eurasia) Affiliate formed ISPE would like to recognize our newly formed Eurasian Economic Union (Eurasia) Affiliate. The Affiliate provides a local forum through which professionals in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan can contribute to the advancement of the pharmaceutical manufacturing industry. Learn More IT Services: Applying Good It Practice & Automation Pharmaceutical Engineering Magazine This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for... 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. 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